Megaprosthesis versus Allograft Prosthesis Composite for massive skeletal defects

G Model JCOT 459 No. of Pages 18

Journal of Clinical Orthopaedics and Trauma xxx (2017) xxx–xxx

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Review article

Megaprosthesis versus Allograft Prosthesis Composite for massive skeletal defects Deepak Gautam, Rajesh Malhotra* Department of Orthopedics, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi, 110029, India

A R T I C L E I N F O

Article history: Received 1 September 2017 Accepted 20 September 2017 Available online xxx Keywords: Megaprosthesis Allograft prosthetic composite Massive skeletal defect Bone tumors Failed total hip arthroplasty Complex trauma

A B S T R A C T

Massive skeletal defects are encountered in the setting of tumors necessitating excision, failed total hip arthroplasty with periprosthetic bone loss, periprosthetic fracture, complex trauma, multiple failed osteosynthesis and infection. Reconstruction of the segmental defects poses a tremendous challenge to the orthopaedic surgeons. The goal of osseous reconstruction of these defects is to restore the bone length and function. Currently the most commonly employed methods for reconstruction are either a megaprosthesis or an Allograft Prosthesis Composite (APC). Megaprosthesis, initially created for the treatment in neoplastic pathologies are being used for the nonneoplastic pathologies as well. The longevity of these implants is an issue as majority of the patients receiving them are the survivors of oncologic issue or elderly population, both in which the life expectancy is limited. However, the early complications like instability, infection, prosthetic breakage and fixation failure have been extensively reported in several literatures. Moreover, the megaprostheses are non-biological options preventing secure fixation of the soft tissue around the implant. The Allograft Prosthesis Composites were introduced to overcome the complications of megaprosthesis. APC is made of a revision-type prosthesis cemented into the skeletal allograft to which the remaining soft tissue sleeve can be biologically fixed. APCs are preferred in young and low risk patients. Though the incidence of instability is relatively low with the composites as compared to the megaprosthesis, apart from infection, the newer complications pertaining to APCs are inevitable that includes non-union, allograft resorption, periprosthetic fracture and potential risk of disease transmission. The current review aims to give an overview on the treatment outcomes, complications and survival of both the megaprostheses and APCs at different anatomic sites in both the upper and lower limbs © 2017

1. Introduction Massive skeletal defects are encountered in orthopaedic practice because of the bone loss due to tumor, infection, pseudotumor, osteolysis following joint replacement, complex fractures, and, failure of a megaprosthesis. The currently available solutions for the massive skeletal defects include either prosthetic implants (i.e., megaprosthesis) or skeletal allograft prosthesis composite (APC). Each of them have their own advantages and disadvantages. The mega prostheses have been widely used since the evolution of limb salvage surgery in the late 1970s. The custom-made

* Corresponding author at: Room No 5019, Department of Orthopedics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India. E-mail address: [email protected] (R. Malhotra).

implants were being used before the development of modular prostheses and their use has been extended to replace the proximal humerus, distal humerus or an entire humerus in the upper extremity. Similar implants have been developed to replace the proximal femur, distal femur, entire femur, proximal tibia, distal tibia and entire tibia as well. Most of them are designed in such a way that the soft tissue sleeve is mobilised and directly fixed over the prosthesis. 1,2 These reconstructions were insufficient due to the lack of muscle strength and subsequent instability of the adjoining joint leading to impaired function. 3 On the other hand, infection and loosening have remained as the main issues following reconstruction with the megaprosthesis.4 The Allograft Prosthesis Composites (APC) were introduced to reduce the complications of megaprostheses. The APC basically constitutes a revision type prosthesis inserted inside the skeletal allograft. The residual muscles and tendons can be attached to the

https://doi.org/10.1016/j.jcot.2017.09.010 0976-5662/© 2017

Please cite this article in press as: D. Gautam, R. Malhotra, Megaprosthesis versus Allograft Prosthesis Composite for massive skeletal defects, J Clin Orthop Trauma (2017), http://dx.doi.org/10.1016/j.jcot.2017.09.010

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allograft bone to purportedly reduce the risk of postoperative instability and provide better function.5 However, the APCs are also not devoid of complications. Periprosthetic bone resorption, nonunion at the graft-host bone junction, fractures, infection and risk of disease transmission are the complications associated with this reconstruction method. 6 The megaprostheses implantations are easy but non-biologic procedures with limited longevity whereas reconstruction with allograft gives an advantage of osteoconduction but with inherent complications. The current review gives an overview of the treatment outcomes, complications and survival of each treatment modality for different anatomic sites in both the upper and lower limbs. At the end, we also discuss the merits of these two procedures by reviewing the recently available literatures comparing them. It is imperative to mention that megaprostheses are in use since a longer duration than the APCs which may be directly related to the availability of bone bank facility in the hospitals as well as the competence of the surgeons as the letter technique is demanding and requires a learning curve. 2. Megaprosthesis for massive skeletal defects 2.1. Upper limb 2.1.1. Proximal humerus The reconstruction of the proximal humerus for massive bone defects depends on the type of resection as well the intactness of functional abductor system i.e. the rotator cuff and the deltoid muscle. Kassab et al. 7 advocated that if the resection removes the rotator cuff and the deltoid muscle (axillary nerve) then one can go either for a megaprosthesis or scapulohumeral arthrodesis. However, if the resection preserves the rotator cuff and/or the deltoid muscle, the reconstruction can be done with an allograft prosthesis composite and attaching the cuff muscles to the allograft bone. In their own study, Kassab et al. have mentioned that glenohumeral instability remains the most frequent complication following the reconstruction of proximal humerus which was seen in 37.9% of their 29 cases. The results of megaprosthesis in proximal end of humerus are affected by the fact that majority of the bone defects in the proximal humerus occur due to neoplastic lesions which are commonly seen in the paediatric patients who almost invariably require revisions. Although, the advancement in surgical technique and metallurgy have shown the improvement in functional outcome with the newer prostheses, the complications especially the neurovascular injuries, loosening of the component, instability and infection, and the need for repeated surgical procedures remain major challenges.8 The outcomes of use of megaprosthesis in different studies are summarized in Table 1.

Recent developments include silver-coated megaprosthesis to reduce the rate of infection and, trevira tube combined with the megaprosthesis to allow attachment of the remaining muscles and tendons by using fibre-wire sutures. Schmolders et al.10 found only one case of infection at a mean follow up of 26 months in their series of 30 patients treated with silver-coated megaprosthesis for proximal humeral reconstruction. Fifteen of the 30 megaprostheses were combined with trevira tube. Three patients (10%) had subluxation of which only one had to undergo a revision surgery. However, the authors failed to mention whether the subluxation occurred in the cases with trevira or without it. Marulanda et al.11 used aortograft mesh to facilitate soft tissue attachment and provide mechanical constraint, and improve the stability of shoulder reconstruction following tumor resection. There was no incidence of shoulder dislocation reported in their series of 16 patients at a mean follow up of 26 months. Further, only one patient had a superficial wound infection and none had deep infection necessitating removal of the graft and/or the prosthesis. 2.1.2. Distal humerus and elbow The distal humerus and the elbow joint are the uncommon sites for bone tumors or the metastasis. In majority of the cases, megaprostheses are indicated in the setting of failed previous arthroplasty, complex intraarticular fractures or failed osteosynthesis with bone loss. Arthrodesis is least acceptable in case of elbow. Although the survivorship of majority of the reconstruction options available is very much limited, the patients invariably want their elbow to be functioning to carry the activities of daily living. Also, successful reconstruction of the elbow gives more satisfaction to the patients. Megaprostheses are required when even the conventional revision elbow prosthesis becomes insufficient to address the massive skeletal defects. Both modular as well as custom made prostheses have been described in the literature. However, there are only few published studies and majority of them are retrospective analysis with few number of subjects that too with broad spectrum of indications including both neoplastic and nonneoplastic conditions. The outcomes reported in different studies are summarized in Table 2. Megaprosthesis using principle of compressive osteointegration have recently been introduced to enhance osteointegration by stable compression, preventing stress shielding and hence reducing the incidence of aseptic loosening. This technology involves compressing a porous-coated spindle at the implant-bone interface by a premeasured amount of force through washers and a traction bar, which in turn is secured in adjacent bone with pins. It has been used in cases with large osseous defects with remaining small segment of bone. Goulding et al.12 retrospectively reviewed 13 such prostheses in 9 patients of which seven were implanted in

Table 1 Summary of the data from the recent studies on the use of megaprosthesis for the management of massive skeletal defects in proximal humerus. Authors

Diagnosis

No of patients Average age (years)

Average Follow up

Clinical outcome

Dubina et al.9 Schmolders et al.10

Tumors

761 (30 studies) 30 (15 with trevira tube)

45

70.5

MSTS = 74% –

41

26 m

EFS = 20

12 cranial migration of prosthesis

Marulanda et al.11

Malignancy

16 (Aortograft mesh)

51

26 m

–

–

Primary tumors and metastasis

Radiological Outcome

Complications

Result

Survival

17% mechanical failure* 4% infection 2 subluxations 1 luxation and infection 1 RNP 1 recurrence 3 fractures 1 superficial wound infection

10% revisions 3 revisions

–

1 death from disease

83% at one year, 63% at 2 years

–

Abbreviations: EFS = Enneking Functional Score, RNP = Radial Nerve Palsy, m = months, *Mechanical failures including prosthetic loosening, fracture, and dislocation, CPS = Compliant Pre-stress Device, GH = Glenohumeral,PH = Proximal Humerus, SOH = Shaft of Humerus, DH = Distal Humerus.

Please cite this article in press as: D. Gautam, R. Malhotra, Megaprosthesis versus Allograft Prosthesis Composite for massive skeletal defects, J Clin Orthop Trauma (2017), http://dx.doi.org/10.1016/j.jcot.2017.09.010

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Table 2 Summary of the data from the recent studies on the use of megaprosthesis for the management of massive skeletal defects in distal humerus and elbow. Authors

Diagnosis

No of Average Average patients age (years) Follow up

Clinical outcome

Radiological Outcome

Complications

Result

Survival

Goulding et a.12

Tumors and Failed TER

13 (CPS) 45

68 m

–

–

6 revisions

–

3 PH 6 DH 1 SOH 36

25 m

MEPS = 77.08

3 RNP

2 lack of CPS fixation (one breakage) 2 loosening of ulnar component 1 bushing wear 1 infection 2 GH subluxation 23 deaths from disease

Capanna et al.13

31 Tumors

60.1

5 Failed TER Abdullah et a.14 Tang et al.15

Weber et al.16

2 Failed TER 1 Failed TER + SHA Tumors

MSTS = 22.9

3

–

6–24 m

1 UNP 1 infection 1 disassembly DASH = 53.76 –

25

38.1

45.4 m

MSTS = 23.9

Tumor and 23 Failed TER/APC 7 THRE

5 APC 11 TER

46

46 m

MSTS = 23

2 aseptic loosening of the ulnar component 2 aseptic loosening of the humeral component

5 stable Allograft 3 stable periprosthetic lysis around ulnar component 2 loosening of humeral component

93% at 5 years

5-year survival = 25.1%

None had any complications

–

–

4 revisions

11 deaths from disease

–

4 recurrence 2 nerve palsy and transient vascular compromise 1 ulnar nerve transection 8 deaths from disease 3 deaths 1 UNP unrelated to disease 1 RNP

–

1 PINP 2 infections Abbreviations: m = months, TER = Total Elbow Replacement, MEPS = Mayo Elbow Performance Score, MSTS = Musculoskeletal Tumor Society Score, DASH = Disabilities of Arm Shoulder and Hand Score, RNP = Radial Nerve Palsy, UNP = Ulnar Nerve Palsy, THRE = Total Humeral Replacement Endoprostheis, APC = Allograft Prosthesis Composite, PIN = Posterior Interosseous Nerve, SHA = Shoulder Hemireplacement Arthroplasty.

distal humeri and two in proximal ulna. At a mean follow up of 68 months, six of them had to undergo revision-all after two years of surgery. Only two failures were attributed to fixation failure. The other failures were for bushing wear, aseptic loosening and infection. 2.2. Lower limb 2.2.1. Proximal femur Massive bone loss in proximal femur is a complex condition which is usually seen both in neoplastic conditions following excision of bone tumors and metastasis, as well as in nonneoplastic conditions like failed arthroplasty, infection, complex trauma and periprosthetic fractures or multiple failed attempts at osteosynthesis. A large majority of these patients are young and are expected to live longer than the reconstruction thus requiring adequate bone stock for further revisions. The authors have an extensive experience of treating young patients with primary bone tumors and failed total hip arthroplasty with allograft prosthesis composites. On the other hand, patients with metastases, failed bipolar or unipolar hemiarthroplasty, multiple failed osteosynthesis and complex fractures in elderly are indications for megaprosthesis due to low demand and limited life expectancy with reduced likelihood of revision. The historically used monoblock megaprostheses were initially replaced with custom made prosthesis and now with the modular ones. Most of the authors have reported the use of megaprosthesis at different sites in a single series. The outcomes of use of megaprosthesis in different studies are summarized in Table 3. Despite the ease of reconstruction for restoring the structural deficiency with megaprostheses, complications are encountered

similar to those with other anatomic sites. One of the most frequent complication is dislocation. The higher incidence of dislocation is attributed to the inability to secure the residual soft tissue to the metal prosthesis .41 Ueda et al.39 used constrained Total Hip Megaprosthesis to achieve the ilio-femoral stabilization and reduce the risk of hip dislocation. Postoperative dislocation was seen in only 4 of their 25 patients treated with constrained megaprostheses following excision of the periacetabular tumors. The use of constrained liners may decrease the incidence of dislocation; however, the authors caution regarding the problems with the use of constrained liners like aseptic loosening of the acetabular component and the catastrophic failure in osteoporotic elderly patients. Nowadays, with the availability of larger heads and dual mobility cups, the use of constrained liners may be reduced. Infection remains the other major problem. The use of sliver coated megaprostheses as mentioned in the literature is supposed to reduce the rate of infection because of the antimicrobial activity of the silver.42 Hardes et al.30 compared the infection rate in 51 patients implanted with silver coated megaprostheses (22 proximal femur and 29 proximal tibia) with 74 patients in whom uncoated Titanium megaprostheses (33 proximal femur and 41 proximal tibia) were used for bony reconstruction following excision of sarcomas. At the mean follow up of 54 months, the infection rate was found to be substantially low in the silver group (5.9%) as compared to the Titanium group (17.6%). The infection rate in proximal femoral megaprosthesis alone was 4.5% in the silver coated group and 18.2% in the uncoated group. Periprosthetic fracture and/or the prosthetic breakage and subsequent implant failure remains the other problem with these expensive megaprostheses. Parvizi et al.36 advocated that the prerequisite for a successful proximal femoral replacement is the

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Table 3 Summary of the data from the recent studies on the use of megaprosthesis for the management of massive skeletal defects in proximal femur. Authors

Diagnosis

No of patients

Average age (years)

Average Follow up

Clinical outcome

Radiological Outcome

Complications

Natarajan et al.17

Multiple Myeloma

6 (3 PF; 3 SF)

47.7

88.2 m

2 Excellent

One loosening

1 skin necrosis 2 deaths from disease 1 periprosthetic fracture

No loosening No dislocation

2 superficial infections

All alive at latest – follow up

One aseptic loosening

3 dislocations

3 revisions

2 infections

2 deaths from disease 2 deaths from disease

2 Good

Khan et a.18

Giant cell tumor

12

36

4.8 y

Ilyas et a.19

Malignant tumors

15

37

6.7 y

Bruns et al.20

Malignant tumors (23) & Non– neoplastic (22)

25 (7 PF)

40.1

2.5 y

2 Fair Mean clinical score of 28.3 (25–30) MSTS = 19

MSTS = 24.9

11 stem stress shielding

KI = 82%

Donati et al.21

Tumors

25 Malignant tumors (22), GCT (2), Osteoblastoma (1)

34

12.25 y

7

17 stem stress shielding

10 Good 7 Fair 1 Poor Bernthal et al.22 Shih et al.23

Donati et al.24

Ahlmann et al.25

Sarcomas

24 (7 PF, 9 DF, 8 PT)

37

13.2 y

MSTS = 25.9

–

Failed THA with massive bone loss

12

59

5.7 y

HHS = 83

1 HO

–

3 GT displacement 1 aseptic loosening –

Primary or metastatic tumors

Bone neoplasia

68 (38 SC, 30 UC)

211 (96PF, 78 DF, PT 30, TF 7)

61.6

50

46.5 m

37.3 m

MSTS = 22.25

5 Aseptic loosening

PF = 22 DF = 22.9

DF 4

PT = 22.25

PT 1

TF = 19.5

Bertani et a.26

Tumors and Nonneoplastic conditions

23 (13 Tumors, 8 Failed THA, 2 Trauma)

65  17.2 5.4 y

MSTS = 16.2

1 Aseptic loosening

2 extensor mechanism rupture 1 DVT 1 Septic loosening 1 dislocation of hip 1 infection

Result

4 revisions

14 re-surgeries

8 infections 2 relapse 9 Fatigue 29 revisions, failure 5amputations 11 Infections 6 recurrence (PF 3, DF 2, PT 1) 10 dislocations 97.6% limb survival at 10 years 1 Fracture

2 infections

66.7% at 5 years

–

87% at 7 years

1 revision

1 dislocation 1 stiff knee 1 recurrence of disease – All walking without aids 5 dislocations 2 revisions 3 Girdle stone arthroplasty 4 infections

4

Survival

5 revisions

–

– –

–

60% at 10 years

PF 82%

DF 58% PT 82% TF 100% 81.5% at 10 years

1 tumor extension 1 stem fatigue fracture Calabro et al.27 Malignant Tumors (7 failed previous prosthesis)

Calori et al.28

Non-union, Complex Fractures and Failed THAs

109 95 cemented 14 cementless

60

32 (11 PF, 13 DF, 2 PT, 64 6 TF)

2.5 y

18 m

MSTS = 21

–

–

5.8%infection

–

3.9% dislocation 2.9% recurrence 1%acetabular fracture 1 dislocation

6 deaths from disease

74% at 9 years

–

–

1 fracture (DF)

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Table 3 (Continued) Diagnosis

No of patients

Average age (years)

Average Follow up

Clinical outcome

Radiological Outcome

Complications

Result

Survival

Periprosthetic fractures Sarcomas

16

75

19.2 m

OHS = 39

–

2 dislocations

–

–

125

37

19 m 54 m

–

–

Infection

Revisions

–

55 PF 70 PT

22 SC + 23 UC SC + 41 UC

Ji et al.31

Tumors

Korim et al.32

Non-neoplastic conditions

7 (3 PF, 1 DF, 2 PT, 1 Patella) 356 14 studies

Authors

Curtin et al.29 30

Hardes et al.

Lundh et al.33

17 2 CF Knee 10 PPF Knee 5 PPF Hip

5 8 2 2

Ruggieri et al.37

GCT Non- Neoplastic conditions

Sarcomas

27 m

MSTS93 = 81%

3.8 y (0– – 14)

77

44 m

–

– 2.5 % loosening

–

PF DF TF Primary prosthesis

Hattori et al.34 Metastasis

Gosal et a.35 Parvizi et al.36

28

19 PF 2 IC 1 TKA 11 48

23

5.9% 17.6% PF: 4.5 vs 9 vs 9 % 18.2% PT: 6.9 vs 17.1% 3 vs 32 % 1 local 1 revision recurrence

83% implant retention 7.6% infection 0.5% prosthesis fracture 1% periprosthetic fracture 3 infections

Primary neoplasms 49 and metastasis

61.8

2.5– 86 m

MSTS = 62.3%

32 73.8

10.6 y 36.5 m

MSTS = 26.8 HHS = 64.9

21

148 m

MSTS = 66%

– 2 radiolucencies >2 mm

–

–

–

28% excellent

–

60% good

Ueda et al.39

Periacetabular tumors

12 primary 37 metastasis 25

Tumors

17 (4 PF, 7 DF, 6 PT)

9 deaths at latest 94% at 44 follow up months

2 dislocations

1 revision

86.4 % at 6 months

– 8 dislocations

– 10 revisions

100% 87% at 1 year

1 infection 4 acetabular failure 1 Leg ischemia 5 revisions

44

163 m

MSTS = 55%

1 prosthetic disconnection 1 poly wear 1 PPF 3 dislocation

–

MSTS = 78.3%  16.6%

73% at 5 years

38% disease free at 16 years

13 deaths from disease

2 deaths from disease

1 infection 1 recurrence 2 aseptic loosening

8 infections

5 revisions

4 dislocations

13 deaths from disease 1 hemipelvectomy 3 implant removal

7 local recurrence

Tan et al.40

12 % mortality

2 dislocations

1 infection

Mazurkiewicz et al.38

–

–

7 infections

47% at 5 years as well as at 10 years

75.6 months implant survival

2 dislocations 1 CPN palsy Abbreviation: PF = Proximal Femur, SF = Shaft of Femur, DF = Distal femur, TF = Total Femur, PT = Proximal tibia, MSTS = Musculoskeletal Tumor Society Score, KI = Karnofsky Index, DVT = Deep Vein Thrombosis, GCT = Giant Cell Tumor, THA = Total Hip Arthroplasty, HHS = Harris Hip Score, HO = Heterotopic Ossification, SC = Silver Coated, UC = Uncoated, OHS = Oxford Hip Score, m = months, y = years, CF = Comminuted Fracture, PPF = Periprosthetic Fracture, IC = Intercalary, TKA = Total Knee Arthroplasty, CPN = Common Peroneal Nerve.

Please cite this article in press as: D. Gautam, R. Malhotra, Megaprosthesis versus Allograft Prosthesis Composite for massive skeletal defects, J Clin Orthop Trauma (2017), http://dx.doi.org/10.1016/j.jcot.2017.09.010

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Table 4 Summary of the data from the recent studies on the use of megaprosthesis for the management of massive skeletal defects in distal femu. Authors

Diagnosis

No of patients

Agarwal et al.43

Osteosarcoma

135 (92 megaprosthesis)

Average Mean age (years) Follow up 32.4 m

Clinical outcome

Radiological Outcome

Complications

Result

Survival

EFS

3 loosening

8 infections

5 revisions

61% disease free survival at latest follow up

1 limb ischemia

3 amputations

LE = 85%

4 PPF

UE = 66%

3 implant breakage 2 recurrences 2 CPN palsy 1 RNP 2 extensor mechanism rupture

1 hip disarticulation 2 implant removal

49 DF, 22 PT, 14 PH, 3 PF, 3 TH, 1 DH)

Bruns et al.44

Malignant tumors (23) & Non-neoplastic (22)

25 (13 PF, 5PT, 7 40.1 PF)

2.5 y

MSTS = 24.9

11 stem stress shielding

KI = 82%

Ilyas et al.45 Tumors

Pala et al.46

Toepfer et.47

Tumors

48

247 (187 DF, 60 PT)

Tumors &

129(82 reviewed)

Failed Revision TKA

36 available

24

32

5.6 y

2y

MSTS = 21

MSTS = 81%

2 aseptic loosening

14 aseptic loosening (5.7%)

15 aseptic loosening (20%) 86m

20 Tumors 16 Failed rTKA Biau et al.48 Tumors

Ahlmann et al.49

Cannon50

Diaphyseal tumors

PPF of Distal Femur

Chim et a.51 Tumors

Evans et al.52

Trauma

91 (58 MP, 33 APC)

46.2  22.1 71,0  13,3 27 62 m

MSTS = 17 MSTS = 12 –

18 aseptic loosening (20%)

1 DVT 1 Septic loosening 1 dislocation of hip 6 infections

1 revision

2 SNP CPN palsy

1 recurrence 7 deaths from disease

14 recurrence (5.7%) 17 soft tissue failure (22.7%)

81.8  7.3 months implant survival

64.6% overall failure

10 failures 8 failures

23 deaths

MSTS = 90%

1 loosening of humeral prosthesis

1 humeral revision

3 Tibia 2 Femur 1 Humerus 27

–

6m

KSS = 88

–

1 infection

–

10

3y

TESS = 62.5

No loosening

70.2

47 deaths from disease

28 structural failure (37.3%) 13 infections (17.3%) 2 recurrences

21.6

–

65% at 10 years

70 % at 4 years, 58 % at 8 years

42

32 m

1 amputation

87% at 7 years

21 limb ischemia 1 prosthetic fracture 1 prosthetic fracture 1 PPF 23 infection 24 deaths from (9.3%) disease

56 DF 35 PT 6 ICEP

10 (5 DF & 5 PT) 31

2 deaths from disease

21 revisions 15 revisions All doing well

130 m 117 m 100% at one year 83% at 2 years

8 deaths unrelated to disease

–

1 delayed wound healing 1 infection 3 metastases and – deaths 1 superficial skin necrosis 1 cellulitis (All resolved) 4 recurrence All doing well

1 death unrelated to surgery

–

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Table 4 (Continued) Authors

Diagnosis

No of patients

Average Mean age (years) Follow up

Clinical outcome

Radiological Outcome

Complications

Result

Survival

Gosheger et al.53

Sarcomas

250

30.7

EFS:

20 aseptic loosening (8%) 2 cranial subluxation of humeral prostheses

30 infections (12%)

47 deaths due to disease

Prosthetic survival

45 m

39 PH

5 DH

Holl et al.54

Failed TKA

7 TH 41 PF

PH = 21 DH = 23

103 DF 12 TF 42 PT 1 TT

TH = 19 PF = 21 DF = 24 TF = 20 PT = 25 KSS = 68

20 (21 Knees)

73

34 m

2 aseptic loosening

15 DF

4 prosthetic fracture (1.6%)

60.4% at 5 years

3 femoral dislocations 8 poly wear 1 Patellar tendon avulsion

42.3 % at 10 years

2 revisions 1 non-salvage 2 deaths due to infection

–

5 prosthetic fracture

13 deaths from disease

91% at 2 years 83% at 5 years 68 % at 10 years

7 uncontrolled infections

17 deaths unrelated to surgery 10 amputations

6 infections 2 PPF

4PT 2 Both DF & PT 55

Hu et al.

Kinekl et al.56

Pala et al.57

Staals et.58

40.3

Neoplasm and non-neoplastic conditions

Tumors

Tumor

77 (49 DF, 28 PT) 38

687

15 (Expandable Malignant tumors of distal prosthesis) femur

34

8

89 m

46 m

7.9 y

104 m

MSTS = 25.2

EFS = 73%

MSTS = 23.3 (77.6%)

MSTS = 81%

5 loose cemented stems 3 asymptomatic radiolucencies

13 aseptic loosening

3 tumor progressions 15 locking mechanism failure 11 infections

33 aseptic loosening

4 recurrence 3 PPF1 patellar tendon rupture 5 joint stiffness 10 wound problem 41 soft tissue failure

1 loosening

26 structural failure (fixed prostheses only) 57 infections 28 recurrence 8 breakage

2 recurrence 1 infection

Vincent et al.59

–

196 (DF & PT) 109 cemented 87 press fit

–

–

–

–

Torner et al.60

Tumors

7 (6 DF, 1 PF) (Expandable prosthesis)

9.8

65.3 m

MSTS = 26.3

–

Cemented (29): 62% loosening 24% infection 13% fracture Press fit (16): 43% loosening 31% infection 6% fracture 6% LLD 6% recurrence 6% malrotation 1 pelvic metastasis

58% revision rate 57% at 5 years

8 implant removal 5 amputations

Over all 27 % failure rate 206 deaths from disease

70% at 10 years 50% at 20 years

9 revisions & deaths

–

2 amputations 2 deaths due to metastasis No longer use by authors 45 revisions –

2 deaths from disease

71.5% success rate (5 out of 7 functioning well at latest follow up)

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Table 4 (Continued) Authors

Diagnosis

No of patients

Average Mean age (years) Follow up

Vaishya et al.61

Resistant nonunions of DF fractures

10

74

4y

Zimel et al.62

Failed distal femoral prosthesis

27 Compliant Pre-stress Implant

30

90 m

Windhager et al.63

PPF

144 (seven studies)

68.4–81

6–58.6

Clinical outcome

Radiological Outcome

Result

1 implant failure due to MRI done for leg trauma 3 wound – problems

KSS – (pain) = 84 KSS (function) = 88 MSTS = 27 –

–

Complications

1 PPF 3 mechanical failure

4 infections 20 mechanical failures 23 nonmechanical failures

–

Survival

–

2 revised to CPC

–

1 revised to APC 3 amputation 1 fusion 0–55% revisions

–

6.6–45% mortality

Abbreviations: PH = Proximal Humerus, TH = Total Humerus, DH = Distal Humerus, PF = Proximal Femur, DF = Distal Femur, TF = Total Femur, PT = Proximal Tibia, TT = Total Tibia, EFS = Enneking Functional Score, LE = Lower Extremity, UE = Upper Extremity, m = months, PPF = Periprosthetic fracture, CPN = Common Peroneal Nerve. RNP = Radial Nerve Palsy, MSTS = Musculoskeletal Tumor Society score, KI = Karnofsky index, SNP = Sciatic Nerve Palsy, TKA = Total Knee Arthroplasty, rTKA = Revision Total Knee Arthroplasty, MP Megaprosthesis, APC = Allograft Prosthesis Composite, EMF = Extensor Mechanism Failure, ICEP = Intercalary Endoprosthesis, KSS = Knee Society Score, TESS = Toronto Extremity Salvage Score, MRI = Magnetic Resonance Imaging

length of the distal part of the femur. An adequate length is required to obtain a secure fixation of the femoral stem. If the distal bone is severely deficient then it is better to go for a total femoral replacement by sacrificing the remaining bone rather than going for a proximal femoral reconstruction alone. 2.2.2. Distal femur Primary bone tumors, benign as well as malignant are commonly seen around the knee especially at the distal end of femur which is the one of the common site for metastasis as well. Being a weight bearing bone, reconstruction of the distal femur following excision of the tumors is of utmost importance. With modern day effective treatment using neo-adjuvant and adjuvant

chemotherapy, limb salvage is the recommended treatment for tumors wherever possible. Various reconstruction options are available for the reconstruction of distal femur following tumor excision that includes arthrodesis, osteoarticular allograft, rotationplasty, megaprosthesis and allograft prosthesis composite. Because of the accessibility and ease of insertion, megaprosthesis are commonly being used. The other indications for the use of megaprosthesis are failed total knee arthroplasty with massive bone loss, periprosthetic fractures, persistent non-union despite multiple surgeries and comminuted intra-articular fractures in elderly with significant bone loss. The megaprostheses offer early mobility with maintenance of joint motion in these cases. The modern modular megaprostheses have replaced the previously

Table 5 Summary of the data from the recent studies on the use of megaprosthesis for the management of massive skeletal defects in proximal and distal tibia. Authors

Diagnosis

No of patients

Average age (years)

Average Follow up

Clinical outcome

Radiological Outcome

Complications

Result

Survival

Titus et al.64

Tumors

10

48

4y

MSTS = 82%

–

2 CPN Palsy

4 deaths from disease

60% living without disease

100% survival at 18 months

16 infection

No recurrence of infection No revision Excellent result 3 amputation

1 recurrence

8 arthrodesis

Calori et a.65

Post traumatic septic bone defects

9

68

18 m

WOMAC = 74.8 No loosening

Cho et al.66

Tumors

62

26

98 m

MSTS = 24.2

Hardes et al.67

Tumors

Yang et al.68

Aggressive tumors of distal tibia

RH- 44 Fixed = 18 98 SC- 56 SC = 19 UC UC = 16 (Ti) = 42 33 8

–

73.9  11.7% at 10 years

–

–

Infection SC = 8.9% UC = 16.7%

Revision SC = 14.3% UC = 50%

At 5 years SC- 90% UC=84%

MSTS = 66%

1 aseptic loosening

2 infections

2 deaths from disease

63% at 5 years

SC = 38 m UC = 128 m 77 m

2 infections 2 Quadriceps adhesions 6 cerclage wire break –

42% at 10 years Abbreviations: m = months, MSTS = Musculoskeletal Tumor Society Score, WOMAC = Western Ontario & McMaster Universities Osteoarthritis Index, RH = Rotating Hinge, FH = Fixed Hinge, SC = Silver coated, UC = Uncoated, Ti- Titanium.

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Table 6 Summary of the data from the recent studies on the use of Allograft Prosthesis Composite for the management of massive skeletal defects in proximal humerus. Authors

Diagnosis

No of patients

Mean age (years)

Average Follow up

Clinical outcome

Radiological Outcome (loosening/HO)

Complications

Ruggieri et.71

Gorham’s disease

14

35

25 m

MSTS = 77 %

–

Abdeen et al.72

Osteosarcoma(19), chondrosarcoma(8), oligometastasis(3), others(6)

36

23

5y

MSTS = 26

5 superior migration of the humeral head

2 allograft 2 fracture revisions 1 infection and fracture 1 locking mechanism failure 1 infection 1 allograft fracture 1 locking mechanism failure 1 dislocation 3 revisions

Result

Survival

–

88% at 10 years (construct survival)

4 delayed union

Gharedaghi et al.73

Bone tumors

102 8 Pelvis

24.5  5.39 2 y

–

3 loosening 3 prosthetic osteolysis –

12 PF 18 SOF 36 DF 12 PT

Black et al.74 Malignant bone tumors

Chacon et al.75

Patient treated with Reverse shoulder arthroplasty

16 humeri 6

40.7 years

Initial = 25.2y MSTS = 74% Second = 55y

–

25

–

30.2 m

1 Metaphyseal resorption 2 Fragmentation

ASES = 69.4

1 Diaphyseal Resorption

Dudkiewicz et al.76

Osteosarcoma

11

17–74

–

Kassab et al.7

Malignant bone tumors

29

–

85 m

Lazerges et a.77

Tumors

6

65.5

5.9 y

(Reverse APC)

Potter et al.78

Tumors

Teunis et al.79

Tumors

(29 studies)

Wang et al.80

Tumors

–

MSTS = 72.6% massive prosthesis MSTS = 73%

4 Nonincorporation –

98 m

MSTS: OAG = 71% APC = 79% MP = 69% Minimum 2 y FS:

25

48 m

OAG=50–78% APC=57–91% MP=61–77% MSTS:

–

–

–

–

–

1 death from diseae

–

–

–

1 non-union 1 implant failure 2 dislocation 1 allograft fracture 1 nondisplaced acromion fracture

2 non-union

2 infections 1 recurrent instability 11 GH instability 2 glenoid notches visible

QDASH = 41

49 48.5 17 OAG 16 APC 16 MP Sep-57 693 (616 studied) 143 OAG 132 APC 341 MP

6 Non-union – 6 allograft fracture 8 infection 6 Local recurrence 11 metastasis 48 limited knee ROM

–

–

5 allograft resorption

1 recurrent instability 1 non-union

OAG = 65% APC = 44% MP = 44% Per patient,

OAG = 0–150% APC = 19–79% MP = 4.5–85% 10 instability and subluxations

1 revision – 1 death from disease DFD: OAG = 7 APC = 6 MP = 12 –

2 deaths from disease

At 5 years OAG = 56% APC = 91% MP = 100% At 5 years

33–100% 33–100% 38–100% –

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Table 6 (Continued) Authors

Diagnosis

No of patients

Mean age (years)

Average Follow up

12 OAG 7 APC 7 MP

Clinical outcome

Radiological Outcome (loosening/HO)

OAG = 24.58 APC = 27.00 MP = 22.50

3 MP fractures

Complications

Result

Survival

Abbreviations: m = months, y = years, MSTS = Musculoskeletal Tumor Society Score, ASES Score = American Shoulder and Elbow Surgeons Score, PF = Proximal Femur, SOF = Shaft of Femur, DF = Distal Femur, PT = Proximal Tibia, QDASH = Quick Disabilities of Arm Shoulder and Hand, OAG = Osteoarticular Allograft, APC = Allograft Prosthesis Composite, MP = Megaprosthesis, DFD = Deaths from Disease, FS = Functional Score.

used custom made prostheses. The megaprostheses have been available both with cementless as well as cemented stems. Both fixed and rotating hinge megaprostheses are being used these days as the salvage option in the distal femoral reconstruction for massive skeletal defects. The outcomes of use of megaprosthesis in different studies are summarized in Table 4.

2.2.3. Proximal tibia The indications for the proximal tibial megaprosthesis remain the same as for the distal femur viz a critical bone defects of neoplastic, traumatic or prosthetic origin. However, the reconstruction of extensor mechanism is a great challenge, failure of which may lead to extensor lag and resultant poor knee function. The outcomes of use of megaprosthesis in different studies are summarized in Table 5. Titus et al.64 described their own technique of reattachment of the ligamentum patellae to the porous tibial tuberosity of the proximal tibial megaprosthesis, and protecting the repair with a cerclage wire through the patella and the prosthesis. In their consecutive 10 cases of reconstruction with the same technique they had only one case of ligament avulsion at mean follow up of 4 years. Calori et al.65 reconstructed the patellar tendon by lengthening the fibres of quadriceps tendon or its fascia, or patellar tendon itself, or medial gastrocnemius flap in nine cases

who required patellar tendon reconstruction along with proximal tibial megaprosthesis for post-traumatic septic bone defects. Only one patient presented with rupture of the reconstructed patellar tendon due to fall at 18 months following the surgery. The current authors have also described their own technique of reconstruction of extensor mechanism with composite allograft consisting of a patella– patellar tendon–tibial tubercle.69,70 In our series of 5 patients (4 with TKA and 1 GCT Patella), all of them are functioning well till the latest follow up of 10 years. Apart for the problems with extensor mechanism following megaprosthetic reconstruction around the knee, infection remains the major issue as it is with other sites. The silver coated megaprosthesis are also available for knee reconstruction to reduce the incidence of infection.67 Chim et al.51 mentioned that the use of primary muscle flap to cover the megaprostheses following limb salvage surgery will decrease the infection rates. Pala et al.57 compared the results of fixed and rotating hinge knee prosthesis for reconstruction of distal femoral defects and found that there was no significant difference in implant failure due to aseptic loosening and infection between the two types of prostheses. Hu et al.55 compared the survivorship of cementless and cemented diaphyseal fixed modular rotating- hinged knee megaprosthesis. They found that the survivorship of the cementless fixed component (94% at 5 years) was significantly superior to that of cemented fixed stem (75% at 5 years). In patients with

Table 7 Summary of the data from the recent studies on the use of Allograft Prosthesis Composite for the management of massive skeletal defects in proximal humerus. Authors

Diagnosis

No of patients

Average age (years)

Average Follow up

Clinical outcome

Radiological Outcome

Complications Result

Survival

Mansat et al.81

Failed TER

13

62

42 m

MEPS:

–

4 infections

5 revisions

–

2 non-unions

3 APC removal

64

75 m

4 Excellent 3 Good 1 Fair 5 Poor MEPS = 74

3 partial resorption in humeral side 4 partial resorption in ulnar side

1 infection

1 APC removal

–

60

3.4 y

MEPS = 84

92% incorporated with host bone

3 infection

9 reoperations

–

Amirfeyz et al.82

Failed TER

Morrey et al.83

22 Failed TER

Renfree et al.84

1 Failed hemiarthroplasty 1 resection arthroplasty 1 non-union 5 failed TER 3 humeral nonunion 1 Ulnar non-union

10 (11 elbows) 8 humeral APC 6 Ulnar APC 25

3 fractures 1 non-union

10 (14 APCs)

58

6.5 y

BMES = 20

79% incorporated

HSSES = 37

1 malunion 1 infection

4 resection arthroplasty 4 allograft related failures

–

1 non-union 1 complete resorption of olecranon

1 OM proximal ulna Abbreviations: m = months, y = years, TER = Total Elbow Arthroplasty, MEPS = Mayo Elbow Performance Score, OM = Osteomyelitis, BMES = Bryan-Morrey Elbow Score, HSSES = Hospital for Special Surgery Elbow Score.

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Table 8 Summary of the data from the recent studies on the use of Allograft Prosthesis Composite for the management of massive skeletal defects in proximal femur. Authors

Diagnosis

No of patients

Average age (years)

Average Follow up

Clinical outcome

Radiological Outcome

Complications

Result

Biau et al.85

Tumors

32

41

68 m

–

–

14% revision at 5 years, – 19 % revision at 10 years

McGoveran et al.86

Tumors

16

51

47 m

TESS = 71.2 (37.0 to 91.0)

–

9 revisions; 5 for mechanical reasons and 4 for infection 3 infection

Babis et al.87

Biau et al.88

Chen et al.89

Failed THA

Tumors

Tumors

Chen et al.90

Tumors

Clarke et al.91

1 Malignancy

Donati et al.92

Dubory et al.93

5 Arthritis 5 DDH Tumors

18

10 PF

59.9

–

37.9

12 y

83 m

43 m

HHS = 73 (52 to 85)

TESS = 76 HHS = 90 PMAS = PCSS = 44 MCSS = 49 EFS = 80%

Aseptic loosening in 4

1 loosening

–

Poor functional scores –

14 died

69% at 10 years

infection 5 loosening 4 fracture 4 non-union 2 stem fracture 1 resorption 3 4 infection 5 removal 1 aseptic loosening

19 revised

10 revision

–

1 sciatic nerve palsy

1 died

–

2 DF 2 PH (Autograft Prosthetic composite) 14 (Autograft Prosthetic composite) 11

28.1

65.7 m

EFS = 72.1%

–

1 non-union

3 died

85 % at 5 years

59

49 m

6 patients had no or slight pain on pain score

2 loosening

2 infection

5 revision

61% at 5 years

27

32

58 m

MTSS excellent – in 73%, good in 18 % and fair in 9%

1 non-union

3 revision

–

34.3

14.7 y

PMAS = 15.7 (8 to 21)

1 fracture 1 infection 12 loosening 2 infection

32 Malignancy Tumors

18

39

93 m

MTSS = 77% (15 to 29) MSTS = 80% 1 loosening

Tumors

PF 5 studies

13.5 to 14.5

54.3 to 69.7 m

MSTS = 71 to 86.8 %

–

Loosening and infection most common complications

Langlias F et al.96

Tumors

DF 4 studies PT 4 studies 21

38

10 years

MSTS = 77 %

4 loosening

No infection

8 re-operations

Lee S H et al.97

Total Hip 15 Replacement

60.9

4.2 year

HSS = 83.2

4 non-union 1 non-union

No dislocation 1 infection

3 re-operations

Malhotra R et al.98

Giant Cell Tumors

18

32

54 months

1 dislocation No infection

No re-operation

–

Min L et al.99

Tumors

28

–

56 m

3 died 1 re-operation

–

Lee Y S et al.100

Tumors

24

110 m

Groundland et al.95

46

No revision

Over all 54.1% at 10 year 81.4 % 51 re - operations femoral stem 6 re-operations 86% at 5 and 10 years Failure rate of APC less – than MPs at PF and more than MPs at DF and PT

Eid et al.94

14 Failed THA

72

3 fracture 2 non-union 1 delayed union leading to fracture 19 revisions;

Survival

2 loosening HHS = 91 in 13 – pt HHS = 86 in 5 pt MSTS = 26.5 – HHS = 80.6 –

–

2 infection

No loosening No infection 3 non-union 1 fracture –

2 died

81 % at 10 years

–

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residual minimal bone for stem fixation the newer prostheses that uses the principle of compressive osteointegration have proven low rate of mechanical failure at a follow up of 10 years.62 However, the ultramodern designs of using the expandable prostheses have gained little importance because of the requirement of multiple surgeries and high complication rates.58,60 Staals et al.58 cautioned against their use due to very high revision rate where 9 of his 10 survivors required revision of the implant for mechanical failure. 2.2.4. Distal tibia Reconstruction of distal tibia for massive defects due to any etiology is for restoring the ankle function. There are very few cases of megaprosthetic reconstruction of distal tibia reported in the literature.68 This may be probably due to the limited longevity of megaprosthesis along with its inherent complications. The treatment modality may not be beneficial over ankle arthrodesis. The authors have no experience of using a distal tibial megaprosthesis as a method of reconstruction for massive skeletal defect. 3. Allograft prosthesis composite for massive skeletal defects 3.1. Upper limb 3.1.1. Proximal humerus Allograft Prosthesis Composite (APC) is an alternative option for limb reconstruction for massive skeletal defects of the proximal humerus. The composite is a favorable choice that addresses the reconstructive challenges of restoring the bone stock and reconstructing the soft tissue sleeve meant for providing the stability to the joint. The soft-tissue attachments especially the

rotator cuff muscles can be attached to the allograft bone of the composite and provide a stable functional construct. The outcomes of use of Allograft Prosthesis Composite in Proximal humerus as reported in different studies are summarized in Table 6. Although the attachment of soft tissue sleeve to the allograft bone improve the function, the ultimate result depends on the extent of resection and muscle sacrifice as the rotator cuff muscles are often sacrificed especially in case of tumors. This leads to insufficient abductor action, and hence the instability and poor shoulder function. Reverse shoulder arthroplasty which was introduced to treat the arthritic shoulder with rotator cuff arthropathy operates through the action of remaining deltoid muscle. Nowadays, the reverse shoulder prosthesis is being combined with the allograft with purported advantage of improvement in the function. Lazerges et al.77 reported a series of 6 cases treated with composite reverse shoulder arthroplasty following excision of malignant tumors of the proximal humerus. At a mean follow up of 5.9 years, there was only one case of dislocation requiring revision. Quick Disabilities of Arm Shoulder and Hand (DASH) score improved from 28 to 41 and the VAS score improved from a mean of 5.1 to 2.3. The mean Musculoskeletal Tumor Society Score (MSTS) was 73% at the latest follow up and the mean satisfaction score was 8.1/10. Chacon et al.75 used this reverse shoulder allograft-prosthesis composite for revision of failed shoulder hemireplacement arthroplasty. At an average follow up of 30.2 months, the mean American Shoulder and Elbow Surgeons (ASES)score improved from 31.7 to 69.4 Nineteen patients (76%) reported a subjective good to excellent result. The range of motion improved in all the planes.

Table 8 (Continued) Authors

Diagnosis

No of patients

Average age (years)

Average Follow up

Clinical outcome

Radiological Outcome

Complications

Result

78 % at 20 year for PF

142 pasteurized autograft prosthesis composite for PF, DF, PH

Ye ZM et al.101

Tumors

Wang J W et al.102 Failed THA

12 PF

–

64 m

10 DF 3 PT 15

58.7 y

7.6 years HHS = 81 in 10 patients that retained prosthesis

3 died

1 Fracture

5 APC removed and 2 re - implanted

–

6 revision

93% at 10 yr, 75.5 % at 15yr, 75.5 % at 20 yr 83.5 % at 5 and 10 year

64 years 96 months

HHS = 57

1 loosening

2 non-union

–

36 years

MSTS = 89.3%

–

1 fracture

–

Sternheim A et al.104

21 Failed APC after revision THA Tumor 10 PF

15 years

63 months

65 % for DF 34.7 % for PT 46.9% for PH –

No dislocation

5 loosening

58.1 years

DF PT PH PR Hemipelvis

No loosening

HHS = 67.6

Failed THA in 30 hips in 28 Dysplastic patients hips

5 4 1 1 1

EFS = 23.4

2 Non-union 3 Infections 1 infection

Sternheim A et al.103

Subhadrabandhu S et al.105

Survival

–

2 infection

Abbreviations: m = months, y = years, THA = Total Hip Arthroplasty, TESS = Toronto Extremity Salvage Score, PMAS = Postel and Merle d’Aubigne ’ score, PCSS and MCSS = Physical Component Summary Score and Mental Component Summary Score as a part of Short Form 36 (SF-36) score, EFS = Enneking Functional Score, MP = Megaprosthesis, PF = Proximal Femur, DF = Distal Femur, PT = Proximal Tibia PR = Proximal Radius.

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3.1.2. Distal humerus and elbow Elbow being the less common site for primary tumors and malignancy, most of the APCs are used for salvage of failed previous total elbow arthroplasties or failed union following trauma. The outcomes of use of APCs around the elbow as reported in different studies are summarized in Table 7. 3.2. Lower limb 3.2.1. Proximal femur The reconstruction options for massive proximal femoral bone loss are limited either to a megaprosthesis or an allograft prosthesis composite. The indications for the use of megaprosthesis and their results in different studies have already been discussed in previous section. While the megaprosthesis allows early weight bearing and hence, a superior early outcome, Allograft Prosthesis Composites have shown improved functional outcome

13

and implant survival and therefore a superior long-term outcome. The outcomes of use of APCs around the proximal femur as reported in different studies are summarized in Table 8. Allograft Prosthesis Composites are indicated in younger patients. In addition to the restoration of bone stock by the allograft, the APC allows attachment of the gluteus and iliopsoas tendon thereby preventing instability. The allograft is combined with a long cementless revision stem to make a composite where the proximal part is cemented and the distal part is left as it is to obtain osteointegration with the host bone. The immediate stability is provided by the step cut osteotomy made in the host bone and the reciprocal osteotomy over the adjoining allograft. The permanent stability is achieved after union of the allograft to the host bone. There have been studies regarding the use of Autograft Prosthetic Composite following Extracorporeal irradiation of the resected segment and reimplantation with a conventional

Table 9 Summary of the data from the recent studies on the use of Allograft Prosthesis Composite for the management of massive skeletal defects in distal femur. Authors

Diagnosis

No of patients

Average Mean Follow age (years) up

Clinical outcome

Radiological Outcome

Complications

Result

Survival

Moon et al.107

Tumors

12

19

89 m

MSTS score available for 6 patients;

–

8 patients had complications non-union, fracture, infection and stem perforation

3 nonunion and 2 failures revised

–

Mo S et al.108

Tumors

12

29.5

45.7 m

–

1 fracture

1 died

–

1 1 1 1

Saidi K et al.109

Ye ZM et al.110

Farfalli et al.111

Fractures

7 APC

Tumors

9 RSA 7 DFR 12 PF

Tumors

10 DF 3 PT (Group 1) 50 APC (28 DF, 22 PT) with nonconstrained prosthesi

79

Average = 90% MSTS in 9 patients with preserved limb = 27

KSS = 74.1

–

64 m

EFS = 23.4

No loosening

35 in both

Group 1–69 m

MSTS = 25 in Group 1

–

Group 2–75 m

MSTS = 25.3 in Group 2

(Group 2) 36 APC (17 DF, 19 PT) with constrained prosthesis

4

17

59 m

MSTS = 62%

–

4 revisions

3 revisions

1 dislocation 1 non-union No dislocation

3 died

–

Group 1:

Group 1:

Group 1: 69% at 5 years and 62% at 10 years

8 infection

2 died,

3 fracture

16 APC removed

2 1 1 1

Wilkins Revision of distal RM femoral 112 et al . replacement in tumors

infection instability local recurrence infection

instability loosening local recurrence non-union

Group 2: 3 infection 3 fracture 3 loosening No fracture

Group 2: 80 % at 5 years and 53 % at 10 years

Group 2: 5 died, 9 APC removed

No revision

No loosening No infection Abbreviations: m = months, y = years, APC = Allograft Prosthesis Composite, DF = Distal Femur, PT = Proximal Tibia, RSA = revision systems, DFR = Distal Femur Endoprostheis, KSS = Knee Society Score, MSTS = Musculoskeletal Tumor Society Score.

Please cite this article in press as: D. Gautam, R. Malhotra, Megaprosthesis versus Allograft Prosthesis Composite for massive skeletal defects, J Clin Orthop Trauma (2017), http://dx.doi.org/10.1016/j.jcot.2017.09.010

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arthroplasty. Chen et al.89 reported the use of Proximal Femoral Autograft Prosthesis Composite in 10 of his 14 patients following resection of tumor. There were no complications like infection, fracture or non-union. There was 100% union at the host-irradiated bone junction within 8 months. Another similar study.90 using extensively porous coated stem for constructing the Proximal Femoral Autograft Prosthetic Composite in 14 patients showed that the union was achieved in 12 patients at a mean of 20.3 weeks. There were no major complications reported. The authors suggested that this technique could be a reliable method of managing the massive bone loss in oriental countries where the availability of obtaining allograft is an issue. The Allograft Prosthesis Composites have been currently favored by many over the other reconstruction techniques.87,98– 100 However, the problems like infection, non-union, allograft resorption, periprosthetic fracture and risk of disease transmission continue as major issues. The ultimate outcome depends on the etiology (i.e. neoplastic or non-neoplastic), intactness of soft tissue, size of defect, method of reconstruction, and preparation of the allograft. The patients’ characteristics such as age at presentation, gender, and occurrence of a pathologic fracture plays an important role in determining the function, disability, and health-related quality of life following allograft-prosthesis composite reconstruction of the proximal femur.88

3.2.2. Distal femur and proximal tibia Distal Femur and Proximal Tibia being the common sites for tumor, massive skeletal defects are commonly encountered following wide surgical excision of the lesion. Large defects can also be seen in cases of Failed Total Knee Arthroplasty, infection and complex trauma. Because of the limited longevity of megaprosthesis and the need of future revision, their use has been limited to the elderly only. Biological reconstruction in young patients using osteoarticular allografts have been associated with high rate of failures due to fractures.106 Because of the encouraging results with the use of APCs in the reconstruction of proximal femur and proximal humerus, indications have been extended for their use in distal and proximal tibia as well. The outcomes of use of APCs around the distal femur and proximal tibia, reported in different studies are summarized in Tables 9 and 10 respectively. The various studies (mentioned in the table) have shown good to excellent results following knee reconstruction with the use of APCs in distal femur and proximal tibia. The survivorship has been reported as low as 33% at 10 years for proximal tibia to as high as 80% at 5 years for distal femur. The senior author (RM) has reported the successful outcome of using a dual massive allograft (distal femoral and proximal tibial) for the reconstruction of large femoral and tibial uncontained defects in the setting of revision knee arthroplasty.120 The patient, currently at 11 years follow is doing

Table 10 Summary of the data from the recent studies on the use of Allograft Prosthesis Composite for the management of massive skeletal defects in proximal tibia. Authors

Diagnosis

No of Mean patients age (years)

Average Follow up

Clinical outcome

Campanacci et al.113

–

19

78 m

– 13 patients who retained original implant has MSTS of 22 points (range, 12 to 30 points).

6–16 y

Radiological Outcome

Complications Result

Survival

6 fracture

5 revised

2 non-union

1 died

68 months (6 to 188), 72.2% at 5 year, 56.1% at 10 year

1 infection

Donati D et al.114

Capanna R et al .115

Biau D et al.116

Biau DJ et al.117

Gilbert et al.118

58 tumor 4 reconstruction of failed procedure Tumors

Tumors

Tumors

Tumors

62

24 y

72 m

90% of patients had MSTS higher than 2 loosening 65

1.9 cm of LLD 15 infection

Tumors

73.4% at 5y

4 died

–

3 local recurrences

14

26 APC in PT

26

12

34.9 y

25 y

24 y

34.5 y

4.5 y

62 m

128 m

49 m

MSTS = 83%

–

–

MSTS = 24.3 (81%)

–

2 infection

–

2 prosthesis failure 1 stem fracture 6 infection

9 mechanical failures 6 showed signs 7 fracture of partial resorption 6 infection –

1 deep infection 1 flap failure

Jeon DG et al.119

–

13

26 y

43 m

MSTS = 23.6

1 loosening

3 infection

72 % at 5 38 re-operations (15 revisions) in 18 y patients 43 % at 10 y 10 died 68 % at 5 y 14 revised 3 died No revision 1 re-operation for infection 4 removal of prosthesis

33 % at 10 y 79% at 5 y

76.9 % at 5y

4 non-union Abbreviations: m = months, y = years, LLD = limb length discrepancy, MSTS = Musculoskeletal Tumor Society Score, APC = Allograft Prosthesis Composite, PT = Proximal Tibia.

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Table 11 Summary of the results of different studies comparing the outcome following use of megaprosthesis and allograft prosthesis composite for the reconstruction of massive skeletal defects in different anatomic sites. Authors & Anatomic site

Megaprosthesis

Outcome

Results

Survival

No. of patients

Outcome Mean Followup

Results

Survival

10 y

21% complications

1 revision

88% at 5 years

10

10 y

40% complications

3 revisions

60% at 5 years

118 m

MMT = 4/5 (hip abductors) MSTS = 87%

–

10

60 m

MMT = 4/5 (hip abductors) MSTS = 90%

–

–

Mean No. of patients Follow-up 14 Michiel et al.121 Proximal Humerus Benedetti 10 et al.122 Proximal Femur

Anract et al.123 Proximal Femur Farid et al.124 Proximal Femur

Zehr et al.125 Proximal Femur

APC

20

–

Gait: Lower cadence Higher incidence – of limp and use of crutches

52

146 m

2 infections 10% aseptic loosening MSTS = 70% HAS = 2.8/5 MSTS = 80%

17 (18 MPs)

21 73 + 11 % at 5 years and 0% at 10 years

–

86% at 10 years 20

Gait: Higher cadence Lower incidence Allograft resorption seen of limp and use of in 50% cases without crutches affecting the function

76 m

1 infection

–

77 + 12% at 5 and 10 years

86% at 10 years

10% non-union

8revisions

MSTS = 82% HAS = 4.6/5 MSTS = 87%

58% at 10 years 16(18APCs)

47% complications

18% complications

2 stem breakage

1 persistent nonunion

1 revised to rotationplasty 76% at 10 years 1 hip disarticulation 2 deaths from disease

Zimel et al.126

47

7y

1 loosening 1 infection 1 recurrence 3 instability 11% recurrence

Distal Femur

Muller et al.127 Proximal Tibia

23

62 m

ISLOS Score: 6 Excellent 11 Good

Wunder et al.128 Knee

64 (50 DF, 14 PT)

Minimum 3 years

1 Fair MSTS = 26.3

9 deaths from disease 53% alive with no disease 17% alive with disease 5 failures:

87% at 10 years 38 (Condyle sparing allograft)

18% recurrence

8 deaths from disease

81% at 10 years

68% alive with no disease

11 % alive with disease

78.8% at 10 years

19

1 amputation 4 implant removal 2 infection

7y

91% at 3 years

4 prosthesis breakage

11 (6 DF, 5 PT)

62 m

ISLOS Score:

4 failures:

10 Excellent

1 amputation

11 Good

2 implant removal

1 Fair 4 infection

1 change of inlay MSTS = 20

93.7% at 10 years

22% at 3 years

5 allograft fracture 1 loosening

Abbreviations: y = years, m = months, MMT = Manual Muscle Test, MSTS = Musculoskeletal Tumor Society Score, HAS = Hip Abductor Strength, MP = Megaprosthesis, ISLOS = International Society of Limb Salvage, DF = Distal Femur, PT = Proximal Tibia.

well without any sign of infection, graft failure or loosening of the implant. 3.2.3. Literature review comparing megaprosthesis with allograft prosthesis composite There are very few studies comparing the outcome of megaprosthesis and allograft prosthesis composite for major

reconstruction of massive bone defects. In addition, majority of them are retrospective analyses. The results are different for different etiologies and so are the survivorships. Table 11 summarizes the results of different studies comparing the outcome following use of megaprosthesis and allograft prosthesis composite for the reconstruction of massive skeletal defects in different anatomic sites.

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