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Reamed versus minimally reamed nailing: A prospectively randomised study of 100 patients with closed fractures of the tibia
Injury, Int. J. Care Injured 42 (2011) S4, S17–S21
Reamed versus minimally reamed nailing: A prospectively randomised study of 100 patients with closed fractures of the tibia C. Gaebler a, *, M.M. McQueen b , V. Vécsei c , C.M. Court-Brown b a b c
Sportordination Vienna, Vienna, Austria Academic Department of Trauma and Orthopaedics, Royal Infirmary of Edinburgh NHS Trust, Edinburgh, United Kingdom Department for Trauma Surgery, Medical University Vienna, Vienna, Austria
A R T I C L E
I N F O
Keywords: Intramedullary nailing Reaming Union Complications
A B S T R A C T It is generally accepted that in tibial fractures the results of reamed intramedullary nailing are better than those of unreamed. However, it is not known whether the clinical effects of reaming are cumulative or if minimal reaming would induce the same beneficial effects as more extensive reaming. This international multicentre study has investigated the effects of different degrees of reaming. 100 patients with closed diaphyseal tibial fractures were prospectively randomised in two centres. Method of treatment was reamed nailing up to 12 mm inserting an 11 mm tibial nail (n: 50), and minimally reamed nailing up to 10 mm inserting a 9 mm tibial nail (n: 50). All patients included in the study had follow-up studies at 4, 8, 12, 16, 26 and 52 weeks after trauma. Sixty-six male and thirty-four female patients with an average age of 37.5 years were included in the study. Gender, age, and injury side were identical in both groups. There was no significant difference of complications in the two methods. The rate of deep wound infections was higher in the reamed group (n: 3) versus the minimally reamed group (n: 1). Union occurred earlier in the reamed group (17 wks) compared to patients with minimally reamed nailing (19 wks), and there were more patients with reamed nails in whom the fracture had healed by 16 weeks (57%) versus the minimally reamed group (43%), however, this was not statistically significant. Pain scales were similar for both groups from week 4 to week 52. A considerable number of outcome parameters including knee and ankle function, as well as the comparison of time intervals to restart certain activities, and return to work showed no significant statistical difference between the two groups. However, patients of the extensive reamed group returned earlier to running, training, and normal sports activities. This study found no significant evidence that more extensive reaming gave better results, however there seemed to be a tendency of more aggressive reaming to induce earlier fracture healing with a tendency of faster recovery times. © 2011 Elsevier Ltd. All rights reserved.
Introduction Tibial fractures are the most common fractures of long bones. They are frequently associated with severe soft tissue injuries, which often lead to a high rate of complications such as malunion, non-union and infection. 1 –12 Intramedullary stabilisation for these fractures has already been used by Incas and Aztecs 13 , and was reinvented by European surgeons in the early nineteenth century, using ivory rods. 14 The publications of Gerhard Küntscher opened the era of modern intramedullary nailing with metallic nails. 15 State of the art for treatment of closed tibial fractures is stabilisation with reamed intramedullary nails. It is a well known fact that intramedullary nails can influence fracture healing by mechanical and biologic means. 16 The mechanical effect is through * Corresponding author: Prof. Dr. Christian Gaebler, MD, Sportordination Vienna, Alserstrasse 28/12, 1090 Vienna, Austria. Tel.: +43-1-2280028. E-mail address: [email protected] (C. Gaebler). 0020-1383/$ – see front matter © 2011 Elsevier Ltd. All rights reserved.
the ability of intramedullary nails to splint the fracture in a given position. As the fracture heals and the bone remodels, nails influence healing by how rigidly they stabilise the fracture fragments, and subsequently by how much stiffness they impart into the overall implant-to-bone construct. Further mechanical influence is introduced via reaming increasing bone strain up to 70%, according to Chapman’s review article. 16 The biologic effects of reaming are systemic and local ones. The systemic effects of reaming and then inserting intramedullary devices probably have minimal effects on the fracture healing per se, but undouptly promotes intravasation of fat and bone marrow fuelling the so called second hit phenomena. 17,18 However, Duwelius et al. 19 have shown that the highest pressures occur when inserting the awl to open the intramedullary canal. Several clinical and experimental studies dealing with embolisation during nailing showed that there are significant changes in alveolar arterial gradients, but systemic embolisation had little influence on the development of pulmonary dysfunction, ARDS, and MOF. 20,21
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Additionally to the systemic effects of reaming there are important local ones. Reaming has dramatic acute effects on the diaphyseal blood flow. Reaming a fracture of a long bone stimulates a strong hyperaemic reaction that in experimental animals reaches a level of several times normal. 22 This results in revascularisation of the diaphysis by converting the normal centrifugal blood supply of the cortex to a centripetal one. 23,24 This of course is dependent on the adequacy of blood supply from the periosteum and surrounding soft tissue envelope. This revascularisation can be further influenced by the presence of an intramedullary nail. Nails that fit the cortex tightly might interfere with the revascularisation of the endosteal blood supply. Advocates of unreamed nailing have suggested that intramedullary reaming is detrimental to the endosteal circulation and might therefore be associated with a higher rate of non-union and infection 16,23 –31 , whereas small diameter nails reportedly have low incidences of infection, non-union and malunion when used to stabilise closed and open tibial fractures. 5,27,31 – 35 The introduction of unreamed, small diameter nails in the treatment of tibial fractures with severe soft tissue damage was expected to lead to a decrease of some of these complications. However, other problems, like early fatigue failure of locking nails and locking screws, were reportedly increased by using unreamed, small diameter nails. 12,31,32,36 –43 Court-Brown et al. 39 demonstrated that the use of unreamed nails in the management of the common Tscherne C1 tibial diaphyseal fracture results in a significantly longer time to union, a notable incidence of non-union, the need for further operations and a high rate of failure of the implants compared with reamed nails. A meta-analysis of comparative studies 44 evaluating pros and cons of reamed and unreamed techniques showed a significant benefit of reamed nails in closed fractures. There was also evidence of a tendency for better results of reamed versus unreamed nails in open fractures. 45 The better results of reamed nails might be due to the fact that reaming extrudes marrow cells into the fracture site and into the extracortical hematoma, thus delivering potentially beneficial pluripotent cells to the healing environment. 46 In addition, the finely morselised bone produced by reaming makes more surface area of bone available from which bone morphogenetic proteins can be released into the fracture area and provide more extensive open lattice structural material for bone regeneration and fracture healing. A method to avoid the detrimental effect of reaming on the endosteal blood flow and to avoid heat-induced necrosis, but still obtaining the osteogenetic properties of reamed nailing could be minimal reaming. Although an animal study had shown no long term advantages for limited reaming 47 , the authors had stated that minimal reaming might be advantageous for the stabilisation of tibial fractures. This animal study was followed by another one, by the same authors, where cortical bone porosity and new bone formation after reaming and limited reaming of canine tibias were examined. 48 The conclusion of this study was that limited intramedullary reaming was a biologically sound alternative for the treatment of tibial diaphyseal fractures in which the circulation was already compromised. To delineate any differences in the rate of healing, infection, and compartment syndrome, as well as in the incidence of implant failure, return time to work and sportive activities, and further comparative parameters, we conducted this prospectively randomised study comparing reamed to minimally reamed intramedullary nailing in closed tibial fractures. Material and methods Two European level I trauma centres were involved in this study. The author of this study had worked at both centres and
was well informed of the practices of both of them. Approval for this prospective study was given by the Ethics Committee of the University of the Vienna Medical School. Patients were evaluated by the surgeon on-call whether to be included into the study. The study related selection criteria included closed diaphyseal tibial fractures (diaphyseal, as defined by AO/OTA classification 49,50 ), soft tissue injury Tscherne type C1 and C2 51 , age between 18 and 65 years, and stabilisation within 24 hours of trauma. Cases of an intramedullary canal diameter of less than 9 mm, polytraumatised patients, or those with additional injuries of lower extremities that affected mobilisation, brain trauma, massive lung contusion, ARDS, pathological bone conditions, Paget, patients with terminal diseases, alcoholics, and intravenous drug abusers were excluded from this comparative series. Randomisation of the patients into the 2 groups was achieved by closed envelopes that were distributed from the author of the study to both centres, avoiding surgeon’s selection bias. Patients fulfilling the all selection criteria were randomised to one of the two treatment methods following their signed informed consent. All tibias of the reamed nailing group were reamed up to 12 mm that was followed by the insertion of a 11 mm tibial nail (Stryker/Howmedica GK nail). Those of the minimal intramedullary nailing group were reamed up to 10 mm and a 9 mm tibial nail was inserted (Stryker/Howmedica GK nail). All nails were locked statically. Distraction was avoided. 7,52 If intraoperative imaging showed fracture distraction, traction was released, the nail locked distally and hammered back until image intensifying showed an acceptable result. However, all x-rays were screened for postoperative distraction. Mobilisation with full weight bearing as pain allowed was initiated as soon as possible. All patients included in the study were followed for one year. Follow up examinations took place at 4 weeks, 8 weeks, 12 weeks, 16 weeks, 26 weeks, and 52 weeks after trauma. About 270 outcome parameters were collected for each patient. We analysed the following ones: demographic data (sex, age, injury side, side dominance, mode of injury), fracture characteristics (AO/OTA classification, soft tissue injury, fracture location, intact fibula, initial tibial displacement, union time, reoperations required, malalignment), parameters of surgery (experience of surgeon, amount of reaming, technical complications, early complications as wound infection, DVT, compartment syndrome etc.), functional outcome parameters (pre-fracture mobility, employment time to restart work, change of occupation, activities of daily living as prolonged kneeling, stooping/crawling, prolonged walking walk up stairs, walk on difficult ground etc.; sporting activities, return times to sporting activities). Deep wound infection was considered present if clinical signs, CRP, and cultures from the intramedullary canal or tissue adjacent to the bone and deep to the superficial fascia were positive. Compartment syndrome was diagnosed by clinical and objective parameters. Fasciotomy was performed when compartment syndrome was diagnosed clinically, or when the compartment pressure versus the diastolic blood pressure difference was less than thirty millimetres of mercury. 53 The presence of significant correlation of compartment syndrome and the method of reaming, mode of injury, fracture type (AO/OTA classification), soft tissue injury (Tscherne classification), amount of tibia displacement in anteroposterior (AP) and lateral views (% of displacement was analysed in all patients), fracture location, and of an intact fibula were all investigated. At each follow-up examination of the range of motion of the knee, ankle, and subtalar joints, level of pain via the Visual Analogue Scale (VAS), complications (DVT, superficial wound infection, deep infection, implant failure: proximal screws, distal screws, nail; other complications), time to union, and number reoperations required to achieve union were all recorded.
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Union was defined as the presence of bridging callus on two radiographic views and the ability of the patient to bear full weight on the injured leg (if other injuries allowed). Delayed union was defined as failure of a tibial fracture to heal within 12 weeks, and non-union was defined as failure of a tibial fracture to heal within six months and persistence of pain at the fracture site. 2,3,10,11,40,54 However, Court-Brown et al. 3 , had shown that it was not worth waiting for bridging callus in closed fractures for more than 16 weeks after injury. This parameter was therefore included in the study. If no signs of bridging callus appeared within 16 weeks, and patients complained of pain when walking, exchange nailing (reamed) was performed. The two treatment groups were compared by chi-square tests, Mann-Whitney tests or Student’s t-tests, and confidence intervals for differences in percentages were calculated by Wilsons method. Percentage rates are given in respect to number of patients available at follow-up. Results From November 1999 to June 2002, 100 adult patients with closed fractures of the tibia were included in this prospective study. There were sixty-six males and thirty-four females. Main mode of injury was sports (28%), followed by twists (18%), and falls (18%). Other reasons for tibial fractures were: fall downstairs/slope (9%), pedestrians hit by car (7%), fall from height (6%), MVA (5%), direct blow (5%), and others (4%) All patients with closed fractures of the tibia and an age between 18 and 65 were randomised into reaming (n: 50) or into minimal reaming (n: 50). Table 1 summarises the baseline characteristics in each group, shown as number (%) for categorised factors and mean [sd] for quantitative ones. Comparisons by chi-squared or t-tests showed that the distribution of age, sex, injury side, etc was similar for both groups. Rate of technical complications was low in both groups. Only two misdrillings occurred in the reamed group, none in the minimally group. There were three cases (6%) of additional fractures in the reamed group, and seven cases (14%) in the minimally group. The difference was not statistically significant. Experience of surgeons (consultant level, senior registrar level, registrar level) did not influence the incidence of technical complications. There were no superficial wound infections during their stay at the hospital. Compartment syndrome (Table 2) occurred in eleven patients (22%) of the reamed group and thirteen patients (26%) of the minimally reamed group. This was not statistically significant. There was also no significant correlation of compartment syndrome and mode of injury (p = 0.58), fracture type (p = 0.77), soft tissue injury (p = 0.82), amount of tibia displacement in the AP (p = 0.3) and lateral views (p = 0.29). However, these results showed
Table 1 Baseline characteristics according to treatment group Reaming Age Sex Injury side AO group
Tscherne Fracture location
Male Female R L A B C C1 C2 Proximal Mid Distal Segmental
39 32 18 31 19 34 12 3 44 6 1 26 22 1
[± 13] (64%) (36%) (62%) (38%) (69%) (25%) (6%) (88%) (12%) (2%) (52%) (44%) (1%)
Minimal reaming 36 34 16 29 21 37 7 5 40 10 1 19 30 0
[± 15] (68%) (32%) (58%) (42%) (76%) (14%) (10%) (80%) (20%) (2%) (38%) (60%) (0%)
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Table 2 Primary outcomes according to treatment group
Compartment syndrome Non-union Union by 16 weeks Exchange nailing required Time to union Post-op distraction Post-op malalignment Week 52 distraction Week 52 malalignment
Reaming
Minimal reaming
95% CI
11 0 25 1 17 3 3 1 2
13 0 20 5 19 1 1 0 3
(43%)
–13%, +20% –8%, +7% –6%, +33%
[± 9] (2%) (2%) (0%) (7%)
–0.6%, +5.2% –15%, +6% –15%, +6% –11%, +6% –9%, +14%
(22%) (57%) [± 4] (6%) (6%) (2%) (4%)
(26%)
that there was a trend of compartment syndromes in proximal fractures of the tibia (p = 0.069), as well as in tibial fractures associated with a fracture fibula too (p = 0.053). The number of patients followed up at 4, 8, 12, 16, 26 and 52 weeks were 43, 45, 42, 44, 45, and 45 in the extensive reaming group and 46, 42, 41, 44, 41 and 38 in the minimal reaming group. Although statistics showed no significant influence of treatment on compartment syndrome, non-union, union by 16 weeks, time to union (Table 2), reaming had an obvious tendency to induce earlier fracture healing, and required a lower rate of reoperations leading to union. Fracture distraction of 3 mm and more had no significant influence on non-union, union time, and union at 16 weeks within treatment groups. Return time to certain activities is demonstrated by Table 3. There was a tendency of the reamed group to restart activities including running, training, normal sports, earlier than the minimally reamed group, however, this was statistically not significant. Only 83% of the patients in the reamed group (n: 10) who did consequent training before their accident returned to their regular training, whereas 100% of the minimally reamed group (n: 14) returned to their pre-injury regular training. Four patients developed deep wound infection. All were successfully treated. There were three deep wound infections (6%) in the reamed group, and one (2%) in the minimally reamed group, however, this was not significant (p = 0.61). There were two superficial wound infections (4%) in the reamed group, and three (6%) in the minimally reamed group. Not one case of deep vein thrombosis (DVT) occurred. There were no nail fractures in both groups. Distal screw failure occurred in ten patients (23%) of the reamed group and nine patients of the minimally reamed group (20%). This was statistically not significant. The range of motion of the knee, ankle and subtalar joints was assessed and the incidence of any observed deficit is presented in Table 4. Pain improved continually in both groups (Table 5). There was no significant difference in both groups for these outcome measures. Only three out of the 116 tested variables showed a significant difference between the two groups. Forty-eight patients complained of pain around the knee (Table 6). There was no significant correlation of pain and prominence Table 3 Time to restart activities (in weeks) Reaming Work Awkward postures Prolonged kneeling Stooping/crawling Prolonged walking Walk up stairs/slope Difficult ground Jump Climb ladder Running Training Normal sport
12 8 18 14 12 9 11 25 16 25 14 29
[± 12] [± 5] [± 12] [± 9] [± 9] [± 7] [± 8] [± 14] [± 12] [± 12] [± 11] [± 12]
Minimally reaming 12 9 18 13 13 10 13 20 16 26 17 34
[± 12] [± 7] [± 12] [± 12] [± 9] [± 8] [± 9] [± 10] [± 10] [± 13] [± 9] [± 12]
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Table 4 Deficit of ROM of the injured knee compared to the non-injured one
Week 4 %D
Week 8 %D
Week 12 %D
Week 16 %D
Week 26 %D
Week 52 %D
Knee EF Ankle DF Ankle PF Subt Inver Subt Ever Knee EF Ankle DF Ankle PF Subt Inver Subt Ever Knee EF Ankle DF Ankle PF Subt Inver Subt Ever Knee EF Ankle DF Ankle PF Subt Inver Subt Ever Knee EF Ankle DF Ankle PF Subt Inver Subt Ever Knee EF Ankle DF Ankle PF Subt Inver Subt Ever
Reamed
Minimally reamed
12 93 26 62 54 5 43 17 41 24 2 27 13 32 18 3 23 9 21 17 3 15 6 14 8 2 6 1 9 3
13 81 35 63 56 7 67 23 49 44 5 45 20 38 31 6 26 15 32 17 3 19 7 12 6 2 18 6 9 7
[9] [77] [18] [31] [36] [10] [72] [21] [34] [35] [4] [50] [17] [31] [33] [4] [41] [15] [27] [28] [7] [22] [10] [24] [17] [4] [13] [11] [15] [11]
[15] [102] [25] [32] [40] [9] [81] [23] [39] [38] [7] [96] [21] [32] [37] [8] [66] [19] [33] [30] [5] [73] [19] [21] [18] [4] [66] [18] [20] [19]
p = 0.015
p = 0.014
p = 0.039
Standard deviation in brackets. Knee EF: deficit of ROM of the knee in extension – flexion Ankle DF: deficit of ankle dorsiflexion Ankle PF: deficit of ankle plantarflexion Subt Inver: deficit of subtalar inversion Subt Evers: deficit of subtalar eversion.
Table 5 Improvement of pain according to VAS
Pain scale
Week Week Week Week Week Week
4 8 12 16 26 52
Reamed
Minimally reamed
4.0 3.6 3.4 3.0 2.4 2.0
4.0 4.2 3.9 3.0 3.4 2.0
[1.8] [2.4] [2.6] [2.6] [2.2] [1.8]
[2.3] [2.1] [2.6] [2.3] [2.7] [1.9]
Table 6 Patients complaining of knee pain
No pain Sometimes After exercise Always Needs pain medication Lost
Reaming
Minimally reaming
Nail prominent
17 12 11 4 0 6
12 18 8 0 0 12
0 3 3 1 0
Because of possible problems including heat necrosis – and the fact that intramedullary reaming is detrimental to the endosteal circulation and might therefore be associated with a higher rate of non-union and infection 23 – 27,29 – 31,58 a new generation of nails, that were inserted without reaming due to their small diameter, was developed. However, even more problems due to early fatigue fractures of both screws and nails occurred with these new implants. 12,31,32,36 – 43 A method to avoid the detrimental effect of reaming on the endosteal blood flow and to avoid heat-induced necrosis, whilst retaining the osteogenic properties of reaming is that of intramedullary nailing with minimal reaming. The study we conducted comparing reamed nailing versus minimally reamed nailing showed no significant difference in outcome and complication parameters. However, there seems to be a clear tendency that more aggressive reaming reduces the time of fracture healing compared to the minimal one. Average time to union was 17 weeks in the reamed group and 19 weeks in the minimally reamed group, although this failed to reach statistical significance (95% CI –0.6 to 5.2). Further results showed that fracture healing within 16 weeks occurred in more patients of the reamed group (57%) compared to the minimally reamed group (43%). Moreover, there was only one patient in the reamed group, who required an intervention to achieve union versus five patients in the minimally reamed group. More aggressive reaming had no significant influence on the rate of complications, despite a non significant (p = 0.61) increase on the rate of deep wound infections for the aggressive reamed group. No cases of bone thermal necrosis were noted. 58 More over we did not observe the development of any systemic effects in patients subjective to aggressive reaming. 59,60 Only three out of 116 variables of ROM (knee, ankle and subtalar joint) and further outcome parameters showed a significant difference between the randomised groups. This is actually less than one would expect by chance so there is no evidence that minimal reaming produced different functional outcomes from more aggressive reaming. Comparison of time intervals to restart certain activities showed no difference for return time to work, (12 weeks for both groups). However, patients of the reamed group returned earlier to running, training, and normal sports activities, although this was not significant. The apparent limitation of the present randomised prospective study is its numbers, and to a degree a certain selection bias due to the specialist nature of the two involved centres. It may be that a larger scale study, basing its targets and power analysis on the results of the present one, including also level 2 trauma centres would be able to provide more evidence that minimal reaming offers similar clinical and functional outcome in comparison to the aggressive reaming practice. In conclusion, although there is a tendency for faster fracture healing and earlier return times to sports and working activities in more aggressive reaming compared to minimal reaming none of these parameters reached statistical significance. Acknowledgements
of nails. However, it was obvious that not one of the patients who had no pain around the knee also had a prominent nail. There were obviously more patients of the reamed group who had no pain at all around the knee joint. However, there were also more patients of this group who complained of persistent pain. None of these differences were statistically significant. Discussion The insertion of intramedullary stabilisation devices has become state of the art for treatment of unstable fractures of the tibia. 55 – 57
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Fatigue failure in small diameter tibial nails. Clin Orthop Relat Res 1995;315:119–28. 44. Bhandari M, Guyatt GH, Tong D, Adili A, Shaughnessy SG. Reamed versus nonreamed intramedullary nailing of lower extremity long bone fractures: a systematic overview and meta-analysis. J Orthop Trauma 2000;14:2–9. 45. Bhandari M, Guyatt GH, Swiontkowski MF, Schemitsch EH. Treatment of open fractures of the shaft of the tibia. J Bone Joint Surg Br 2001;83:62–8. 46. Frolke JP, Bakker FC, Patka P, Haarman HJ. Reaming debris in osteotomized sheep tibiae. J Trauma 2001;50:65–9; discussion 50:69–70. 47. Hupel TM, Aksenov SA, Schemitsch EH. Effect of limited and standard reaming on cortical bone blood flow and early strength of union following segmental fracture. J Orthop Trauma 1998;12:400–6. 48. Hupel TM, Weinberg JA, Aksenov SA, Schemitsch EH. Effect of unreamed, limited reamed, and standard reamed intramedullary nailing on cortical bone porosity and new bone formation. J Orthop Trauma 2001;15:18–27. 49. Mueller ME, Nazarian S, Koch P, Schatzker J. The Comprehensive Classification of Fractures of Long Bones. New York: Springer, 1990. 50. Fracture and dislocation compendium. Orthopaedic Trauma Association Committee for Coding and Classification. J Orthop Trauma 1996;10(Suppl 1):v–ix, 1–154. 51. Oestern HJ, Tscherne H. Pathophysiology and classification of soft tissue injuries associated with fractures. In: Tscherne H GL. Fractures with soft tissue injuries. Berlin: Springer-Verlag, 1984:1–8. 52. Gaebler C, Berger U, Schandelmaier P, Greitbauer M, Schauwecker HH, Applegate B, et al. Rates and odds ratios for complications in closed and open tibial fractures treated with unreamed, small diameter tibial nails: a multicenter analysis of 467 cases. J Orthop Trauma 2001;15:415–23. 53. McQueen MM, Court-Brown CM. Compartment monitoring in tibial fractures. The pressure threshold for decompression. J Bone Joint Surg Br 1996;78:99– 104. 54. Hayda RA, Brighton CT, Esterhai JL, Jr. Pathophysiology of delayed healing. Clin Orthop Relat Res 1998;355 Suppl):S31–40. 55. Papakostidis C, Psyllakis I, Vardakas D, Grestas A, Giannoudis PV. Femoralshaft fractures and nonunions treated with intramedullary nails: The role of dynamisation. Injury 2011 [Epub ahead of print]. 56. Tan SL, Balogh ZJ. Indications and limitations of locked plating. Injury 2009;40:683–91. 57. Horne J, Linke B, Hontzsch D, Guerquiev B, Schwieger K. Angle stable interlocking screws improve construct stability of intramedullary nailing of distal tibia fractures: a biomechanical study. Injury 2009;40:767–71. 58. Schroeder JE, Weil YA, Khoury A, Liebergall M, Mosheiff R. Thermal tibial osteonecrosis: a diagnostic challenge and review of the literature. Injury 2009;41:235–8. 59. Giannoudis PV, Tan HB, Perry S, Tzioupis C, Kanakaris NK. The systemic inflammatory response following femoral canal reaming using the reamerirrigator-aspirator (RIA) device. Injury 2010;41(Suppl 2):S57–61. 60. Lasanianos NG, Kanakaris NK, Dimitriou R, Pape HC, Giannoudis PV. Second hit phenomenon: Existing evidence of clinical implications. Injury 2011;42:617– 29.
Reamed versus minimally reamed nailing: A prospectively randomised study of 100 patients with closed fractures of the tibia C. Gaebler a, *, M.M. McQueen b , V. Vécsei c , C.M. Court-Brown b a b c
Sportordination Vienna, Vienna, Austria Academic Department of Trauma and Orthopaedics, Royal Infirmary of Edinburgh NHS Trust, Edinburgh, United Kingdom Department for Trauma Surgery, Medical University Vienna, Vienna, Austria
A R T I C L E
I N F O
Keywords: Intramedullary nailing Reaming Union Complications
A B S T R A C T It is generally accepted that in tibial fractures the results of reamed intramedullary nailing are better than those of unreamed. However, it is not known whether the clinical effects of reaming are cumulative or if minimal reaming would induce the same beneficial effects as more extensive reaming. This international multicentre study has investigated the effects of different degrees of reaming. 100 patients with closed diaphyseal tibial fractures were prospectively randomised in two centres. Method of treatment was reamed nailing up to 12 mm inserting an 11 mm tibial nail (n: 50), and minimally reamed nailing up to 10 mm inserting a 9 mm tibial nail (n: 50). All patients included in the study had follow-up studies at 4, 8, 12, 16, 26 and 52 weeks after trauma. Sixty-six male and thirty-four female patients with an average age of 37.5 years were included in the study. Gender, age, and injury side were identical in both groups. There was no significant difference of complications in the two methods. The rate of deep wound infections was higher in the reamed group (n: 3) versus the minimally reamed group (n: 1). Union occurred earlier in the reamed group (17 wks) compared to patients with minimally reamed nailing (19 wks), and there were more patients with reamed nails in whom the fracture had healed by 16 weeks (57%) versus the minimally reamed group (43%), however, this was not statistically significant. Pain scales were similar for both groups from week 4 to week 52. A considerable number of outcome parameters including knee and ankle function, as well as the comparison of time intervals to restart certain activities, and return to work showed no significant statistical difference between the two groups. However, patients of the extensive reamed group returned earlier to running, training, and normal sports activities. This study found no significant evidence that more extensive reaming gave better results, however there seemed to be a tendency of more aggressive reaming to induce earlier fracture healing with a tendency of faster recovery times. © 2011 Elsevier Ltd. All rights reserved.
Introduction Tibial fractures are the most common fractures of long bones. They are frequently associated with severe soft tissue injuries, which often lead to a high rate of complications such as malunion, non-union and infection. 1 –12 Intramedullary stabilisation for these fractures has already been used by Incas and Aztecs 13 , and was reinvented by European surgeons in the early nineteenth century, using ivory rods. 14 The publications of Gerhard Küntscher opened the era of modern intramedullary nailing with metallic nails. 15 State of the art for treatment of closed tibial fractures is stabilisation with reamed intramedullary nails. It is a well known fact that intramedullary nails can influence fracture healing by mechanical and biologic means. 16 The mechanical effect is through * Corresponding author: Prof. Dr. Christian Gaebler, MD, Sportordination Vienna, Alserstrasse 28/12, 1090 Vienna, Austria. Tel.: +43-1-2280028. E-mail address: [email protected] (C. Gaebler). 0020-1383/$ – see front matter © 2011 Elsevier Ltd. All rights reserved.
the ability of intramedullary nails to splint the fracture in a given position. As the fracture heals and the bone remodels, nails influence healing by how rigidly they stabilise the fracture fragments, and subsequently by how much stiffness they impart into the overall implant-to-bone construct. Further mechanical influence is introduced via reaming increasing bone strain up to 70%, according to Chapman’s review article. 16 The biologic effects of reaming are systemic and local ones. The systemic effects of reaming and then inserting intramedullary devices probably have minimal effects on the fracture healing per se, but undouptly promotes intravasation of fat and bone marrow fuelling the so called second hit phenomena. 17,18 However, Duwelius et al. 19 have shown that the highest pressures occur when inserting the awl to open the intramedullary canal. Several clinical and experimental studies dealing with embolisation during nailing showed that there are significant changes in alveolar arterial gradients, but systemic embolisation had little influence on the development of pulmonary dysfunction, ARDS, and MOF. 20,21
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Additionally to the systemic effects of reaming there are important local ones. Reaming has dramatic acute effects on the diaphyseal blood flow. Reaming a fracture of a long bone stimulates a strong hyperaemic reaction that in experimental animals reaches a level of several times normal. 22 This results in revascularisation of the diaphysis by converting the normal centrifugal blood supply of the cortex to a centripetal one. 23,24 This of course is dependent on the adequacy of blood supply from the periosteum and surrounding soft tissue envelope. This revascularisation can be further influenced by the presence of an intramedullary nail. Nails that fit the cortex tightly might interfere with the revascularisation of the endosteal blood supply. Advocates of unreamed nailing have suggested that intramedullary reaming is detrimental to the endosteal circulation and might therefore be associated with a higher rate of non-union and infection 16,23 –31 , whereas small diameter nails reportedly have low incidences of infection, non-union and malunion when used to stabilise closed and open tibial fractures. 5,27,31 – 35 The introduction of unreamed, small diameter nails in the treatment of tibial fractures with severe soft tissue damage was expected to lead to a decrease of some of these complications. However, other problems, like early fatigue failure of locking nails and locking screws, were reportedly increased by using unreamed, small diameter nails. 12,31,32,36 –43 Court-Brown et al. 39 demonstrated that the use of unreamed nails in the management of the common Tscherne C1 tibial diaphyseal fracture results in a significantly longer time to union, a notable incidence of non-union, the need for further operations and a high rate of failure of the implants compared with reamed nails. A meta-analysis of comparative studies 44 evaluating pros and cons of reamed and unreamed techniques showed a significant benefit of reamed nails in closed fractures. There was also evidence of a tendency for better results of reamed versus unreamed nails in open fractures. 45 The better results of reamed nails might be due to the fact that reaming extrudes marrow cells into the fracture site and into the extracortical hematoma, thus delivering potentially beneficial pluripotent cells to the healing environment. 46 In addition, the finely morselised bone produced by reaming makes more surface area of bone available from which bone morphogenetic proteins can be released into the fracture area and provide more extensive open lattice structural material for bone regeneration and fracture healing. A method to avoid the detrimental effect of reaming on the endosteal blood flow and to avoid heat-induced necrosis, but still obtaining the osteogenetic properties of reamed nailing could be minimal reaming. Although an animal study had shown no long term advantages for limited reaming 47 , the authors had stated that minimal reaming might be advantageous for the stabilisation of tibial fractures. This animal study was followed by another one, by the same authors, where cortical bone porosity and new bone formation after reaming and limited reaming of canine tibias were examined. 48 The conclusion of this study was that limited intramedullary reaming was a biologically sound alternative for the treatment of tibial diaphyseal fractures in which the circulation was already compromised. To delineate any differences in the rate of healing, infection, and compartment syndrome, as well as in the incidence of implant failure, return time to work and sportive activities, and further comparative parameters, we conducted this prospectively randomised study comparing reamed to minimally reamed intramedullary nailing in closed tibial fractures. Material and methods Two European level I trauma centres were involved in this study. The author of this study had worked at both centres and
was well informed of the practices of both of them. Approval for this prospective study was given by the Ethics Committee of the University of the Vienna Medical School. Patients were evaluated by the surgeon on-call whether to be included into the study. The study related selection criteria included closed diaphyseal tibial fractures (diaphyseal, as defined by AO/OTA classification 49,50 ), soft tissue injury Tscherne type C1 and C2 51 , age between 18 and 65 years, and stabilisation within 24 hours of trauma. Cases of an intramedullary canal diameter of less than 9 mm, polytraumatised patients, or those with additional injuries of lower extremities that affected mobilisation, brain trauma, massive lung contusion, ARDS, pathological bone conditions, Paget, patients with terminal diseases, alcoholics, and intravenous drug abusers were excluded from this comparative series. Randomisation of the patients into the 2 groups was achieved by closed envelopes that were distributed from the author of the study to both centres, avoiding surgeon’s selection bias. Patients fulfilling the all selection criteria were randomised to one of the two treatment methods following their signed informed consent. All tibias of the reamed nailing group were reamed up to 12 mm that was followed by the insertion of a 11 mm tibial nail (Stryker/Howmedica GK nail). Those of the minimal intramedullary nailing group were reamed up to 10 mm and a 9 mm tibial nail was inserted (Stryker/Howmedica GK nail). All nails were locked statically. Distraction was avoided. 7,52 If intraoperative imaging showed fracture distraction, traction was released, the nail locked distally and hammered back until image intensifying showed an acceptable result. However, all x-rays were screened for postoperative distraction. Mobilisation with full weight bearing as pain allowed was initiated as soon as possible. All patients included in the study were followed for one year. Follow up examinations took place at 4 weeks, 8 weeks, 12 weeks, 16 weeks, 26 weeks, and 52 weeks after trauma. About 270 outcome parameters were collected for each patient. We analysed the following ones: demographic data (sex, age, injury side, side dominance, mode of injury), fracture characteristics (AO/OTA classification, soft tissue injury, fracture location, intact fibula, initial tibial displacement, union time, reoperations required, malalignment), parameters of surgery (experience of surgeon, amount of reaming, technical complications, early complications as wound infection, DVT, compartment syndrome etc.), functional outcome parameters (pre-fracture mobility, employment time to restart work, change of occupation, activities of daily living as prolonged kneeling, stooping/crawling, prolonged walking walk up stairs, walk on difficult ground etc.; sporting activities, return times to sporting activities). Deep wound infection was considered present if clinical signs, CRP, and cultures from the intramedullary canal or tissue adjacent to the bone and deep to the superficial fascia were positive. Compartment syndrome was diagnosed by clinical and objective parameters. Fasciotomy was performed when compartment syndrome was diagnosed clinically, or when the compartment pressure versus the diastolic blood pressure difference was less than thirty millimetres of mercury. 53 The presence of significant correlation of compartment syndrome and the method of reaming, mode of injury, fracture type (AO/OTA classification), soft tissue injury (Tscherne classification), amount of tibia displacement in anteroposterior (AP) and lateral views (% of displacement was analysed in all patients), fracture location, and of an intact fibula were all investigated. At each follow-up examination of the range of motion of the knee, ankle, and subtalar joints, level of pain via the Visual Analogue Scale (VAS), complications (DVT, superficial wound infection, deep infection, implant failure: proximal screws, distal screws, nail; other complications), time to union, and number reoperations required to achieve union were all recorded.
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Union was defined as the presence of bridging callus on two radiographic views and the ability of the patient to bear full weight on the injured leg (if other injuries allowed). Delayed union was defined as failure of a tibial fracture to heal within 12 weeks, and non-union was defined as failure of a tibial fracture to heal within six months and persistence of pain at the fracture site. 2,3,10,11,40,54 However, Court-Brown et al. 3 , had shown that it was not worth waiting for bridging callus in closed fractures for more than 16 weeks after injury. This parameter was therefore included in the study. If no signs of bridging callus appeared within 16 weeks, and patients complained of pain when walking, exchange nailing (reamed) was performed. The two treatment groups were compared by chi-square tests, Mann-Whitney tests or Student’s t-tests, and confidence intervals for differences in percentages were calculated by Wilsons method. Percentage rates are given in respect to number of patients available at follow-up. Results From November 1999 to June 2002, 100 adult patients with closed fractures of the tibia were included in this prospective study. There were sixty-six males and thirty-four females. Main mode of injury was sports (28%), followed by twists (18%), and falls (18%). Other reasons for tibial fractures were: fall downstairs/slope (9%), pedestrians hit by car (7%), fall from height (6%), MVA (5%), direct blow (5%), and others (4%) All patients with closed fractures of the tibia and an age between 18 and 65 were randomised into reaming (n: 50) or into minimal reaming (n: 50). Table 1 summarises the baseline characteristics in each group, shown as number (%) for categorised factors and mean [sd] for quantitative ones. Comparisons by chi-squared or t-tests showed that the distribution of age, sex, injury side, etc was similar for both groups. Rate of technical complications was low in both groups. Only two misdrillings occurred in the reamed group, none in the minimally group. There were three cases (6%) of additional fractures in the reamed group, and seven cases (14%) in the minimally group. The difference was not statistically significant. Experience of surgeons (consultant level, senior registrar level, registrar level) did not influence the incidence of technical complications. There were no superficial wound infections during their stay at the hospital. Compartment syndrome (Table 2) occurred in eleven patients (22%) of the reamed group and thirteen patients (26%) of the minimally reamed group. This was not statistically significant. There was also no significant correlation of compartment syndrome and mode of injury (p = 0.58), fracture type (p = 0.77), soft tissue injury (p = 0.82), amount of tibia displacement in the AP (p = 0.3) and lateral views (p = 0.29). However, these results showed
Table 1 Baseline characteristics according to treatment group Reaming Age Sex Injury side AO group
Tscherne Fracture location
Male Female R L A B C C1 C2 Proximal Mid Distal Segmental
39 32 18 31 19 34 12 3 44 6 1 26 22 1
[± 13] (64%) (36%) (62%) (38%) (69%) (25%) (6%) (88%) (12%) (2%) (52%) (44%) (1%)
Minimal reaming 36 34 16 29 21 37 7 5 40 10 1 19 30 0
[± 15] (68%) (32%) (58%) (42%) (76%) (14%) (10%) (80%) (20%) (2%) (38%) (60%) (0%)
S19
Table 2 Primary outcomes according to treatment group
Compartment syndrome Non-union Union by 16 weeks Exchange nailing required Time to union Post-op distraction Post-op malalignment Week 52 distraction Week 52 malalignment
Reaming
Minimal reaming
95% CI
11 0 25 1 17 3 3 1 2
13 0 20 5 19 1 1 0 3
(43%)
–13%, +20% –8%, +7% –6%, +33%
[± 9] (2%) (2%) (0%) (7%)
–0.6%, +5.2% –15%, +6% –15%, +6% –11%, +6% –9%, +14%
(22%) (57%) [± 4] (6%) (6%) (2%) (4%)
(26%)
that there was a trend of compartment syndromes in proximal fractures of the tibia (p = 0.069), as well as in tibial fractures associated with a fracture fibula too (p = 0.053). The number of patients followed up at 4, 8, 12, 16, 26 and 52 weeks were 43, 45, 42, 44, 45, and 45 in the extensive reaming group and 46, 42, 41, 44, 41 and 38 in the minimal reaming group. Although statistics showed no significant influence of treatment on compartment syndrome, non-union, union by 16 weeks, time to union (Table 2), reaming had an obvious tendency to induce earlier fracture healing, and required a lower rate of reoperations leading to union. Fracture distraction of 3 mm and more had no significant influence on non-union, union time, and union at 16 weeks within treatment groups. Return time to certain activities is demonstrated by Table 3. There was a tendency of the reamed group to restart activities including running, training, normal sports, earlier than the minimally reamed group, however, this was statistically not significant. Only 83% of the patients in the reamed group (n: 10) who did consequent training before their accident returned to their regular training, whereas 100% of the minimally reamed group (n: 14) returned to their pre-injury regular training. Four patients developed deep wound infection. All were successfully treated. There were three deep wound infections (6%) in the reamed group, and one (2%) in the minimally reamed group, however, this was not significant (p = 0.61). There were two superficial wound infections (4%) in the reamed group, and three (6%) in the minimally reamed group. Not one case of deep vein thrombosis (DVT) occurred. There were no nail fractures in both groups. Distal screw failure occurred in ten patients (23%) of the reamed group and nine patients of the minimally reamed group (20%). This was statistically not significant. The range of motion of the knee, ankle and subtalar joints was assessed and the incidence of any observed deficit is presented in Table 4. Pain improved continually in both groups (Table 5). There was no significant difference in both groups for these outcome measures. Only three out of the 116 tested variables showed a significant difference between the two groups. Forty-eight patients complained of pain around the knee (Table 6). There was no significant correlation of pain and prominence Table 3 Time to restart activities (in weeks) Reaming Work Awkward postures Prolonged kneeling Stooping/crawling Prolonged walking Walk up stairs/slope Difficult ground Jump Climb ladder Running Training Normal sport
12 8 18 14 12 9 11 25 16 25 14 29
[± 12] [± 5] [± 12] [± 9] [± 9] [± 7] [± 8] [± 14] [± 12] [± 12] [± 11] [± 12]
Minimally reaming 12 9 18 13 13 10 13 20 16 26 17 34
[± 12] [± 7] [± 12] [± 12] [± 9] [± 8] [± 9] [± 10] [± 10] [± 13] [± 9] [± 12]
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Table 4 Deficit of ROM of the injured knee compared to the non-injured one
Week 4 %D
Week 8 %D
Week 12 %D
Week 16 %D
Week 26 %D
Week 52 %D
Knee EF Ankle DF Ankle PF Subt Inver Subt Ever Knee EF Ankle DF Ankle PF Subt Inver Subt Ever Knee EF Ankle DF Ankle PF Subt Inver Subt Ever Knee EF Ankle DF Ankle PF Subt Inver Subt Ever Knee EF Ankle DF Ankle PF Subt Inver Subt Ever Knee EF Ankle DF Ankle PF Subt Inver Subt Ever
Reamed
Minimally reamed
12 93 26 62 54 5 43 17 41 24 2 27 13 32 18 3 23 9 21 17 3 15 6 14 8 2 6 1 9 3
13 81 35 63 56 7 67 23 49 44 5 45 20 38 31 6 26 15 32 17 3 19 7 12 6 2 18 6 9 7
[9] [77] [18] [31] [36] [10] [72] [21] [34] [35] [4] [50] [17] [31] [33] [4] [41] [15] [27] [28] [7] [22] [10] [24] [17] [4] [13] [11] [15] [11]
[15] [102] [25] [32] [40] [9] [81] [23] [39] [38] [7] [96] [21] [32] [37] [8] [66] [19] [33] [30] [5] [73] [19] [21] [18] [4] [66] [18] [20] [19]
p = 0.015
p = 0.014
p = 0.039
Standard deviation in brackets. Knee EF: deficit of ROM of the knee in extension – flexion Ankle DF: deficit of ankle dorsiflexion Ankle PF: deficit of ankle plantarflexion Subt Inver: deficit of subtalar inversion Subt Evers: deficit of subtalar eversion.
Table 5 Improvement of pain according to VAS
Pain scale
Week Week Week Week Week Week
4 8 12 16 26 52
Reamed
Minimally reamed
4.0 3.6 3.4 3.0 2.4 2.0
4.0 4.2 3.9 3.0 3.4 2.0
[1.8] [2.4] [2.6] [2.6] [2.2] [1.8]
[2.3] [2.1] [2.6] [2.3] [2.7] [1.9]
Table 6 Patients complaining of knee pain
No pain Sometimes After exercise Always Needs pain medication Lost
Reaming
Minimally reaming
Nail prominent
17 12 11 4 0 6
12 18 8 0 0 12
0 3 3 1 0
Because of possible problems including heat necrosis – and the fact that intramedullary reaming is detrimental to the endosteal circulation and might therefore be associated with a higher rate of non-union and infection 23 – 27,29 – 31,58 a new generation of nails, that were inserted without reaming due to their small diameter, was developed. However, even more problems due to early fatigue fractures of both screws and nails occurred with these new implants. 12,31,32,36 – 43 A method to avoid the detrimental effect of reaming on the endosteal blood flow and to avoid heat-induced necrosis, whilst retaining the osteogenic properties of reaming is that of intramedullary nailing with minimal reaming. The study we conducted comparing reamed nailing versus minimally reamed nailing showed no significant difference in outcome and complication parameters. However, there seems to be a clear tendency that more aggressive reaming reduces the time of fracture healing compared to the minimal one. Average time to union was 17 weeks in the reamed group and 19 weeks in the minimally reamed group, although this failed to reach statistical significance (95% CI –0.6 to 5.2). Further results showed that fracture healing within 16 weeks occurred in more patients of the reamed group (57%) compared to the minimally reamed group (43%). Moreover, there was only one patient in the reamed group, who required an intervention to achieve union versus five patients in the minimally reamed group. More aggressive reaming had no significant influence on the rate of complications, despite a non significant (p = 0.61) increase on the rate of deep wound infections for the aggressive reamed group. No cases of bone thermal necrosis were noted. 58 More over we did not observe the development of any systemic effects in patients subjective to aggressive reaming. 59,60 Only three out of 116 variables of ROM (knee, ankle and subtalar joint) and further outcome parameters showed a significant difference between the randomised groups. This is actually less than one would expect by chance so there is no evidence that minimal reaming produced different functional outcomes from more aggressive reaming. Comparison of time intervals to restart certain activities showed no difference for return time to work, (12 weeks for both groups). However, patients of the reamed group returned earlier to running, training, and normal sports activities, although this was not significant. The apparent limitation of the present randomised prospective study is its numbers, and to a degree a certain selection bias due to the specialist nature of the two involved centres. It may be that a larger scale study, basing its targets and power analysis on the results of the present one, including also level 2 trauma centres would be able to provide more evidence that minimal reaming offers similar clinical and functional outcome in comparison to the aggressive reaming practice. In conclusion, although there is a tendency for faster fracture healing and earlier return times to sports and working activities in more aggressive reaming compared to minimal reaming none of these parameters reached statistical significance. Acknowledgements
of nails. However, it was obvious that not one of the patients who had no pain around the knee also had a prominent nail. There were obviously more patients of the reamed group who had no pain at all around the knee joint. However, there were also more patients of this group who complained of persistent pain. None of these differences were statistically significant. Discussion The insertion of intramedullary stabilisation devices has become state of the art for treatment of unstable fractures of the tibia. 55 – 57
This study was supported by the Lorenz Boehler fund of Austria. The devices that are subject of the manuscript are FDA approved. Conflict of interest The authors have no conflicts of interest to declare. References 1. Bach AW, Hansen ST, Jr. Plates versus external fixation in severe open tibial shaft fractures. A randomized trial. Clin Orthop Relat Res 1989;241:89–94.
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