- Email: [email protected]
Fixation of intra-articular fractures of the distal radius using intramedullary nailing: a randomized trial versus palmar locking plates
Injury, Int. J. Care Injured 47S7 (2016) S25–S30
Contents lists available at ScienceDirect
Injury j o u r n a l h o m e p a g e : w w w. e l s e v i e r . c o m / l o c at e / I n j u r y
Fixation of intra-articular fractures of the distal radius using intramedullary nailing: a randomized trial versus palmar locking plates Gertraud Gradla, Steffi Falkb, Thomas Mittlmeierb, Martina Wendtb, Nadja Mielschb, Georg Gradlc,* a
Department of Trauma and Reconstructive Surgery, Aachen University Medical Center, Pauwelstrasse 30, 52074 Aachen, Germany Department of Trauma- and Reconstructive Surgery, Surgical Clinic University of Rostock, Schillingallee 35, 18055 Rostock, Germany Clinic for Trauma Surgery, Orthopedic Surgery and Reconstructive Surgery, Munich Municipal Hospital Group, Sanatoriumsplatz 2, 81545 München, Germany
b c
K E Y W O R D S
A B S T R A C T
intraarticular distal radius fracture
Background: Proposed benefits of intramedullary techniques include limited soft tissue dissection while affording sufficient stability to allow early wrist motion. The primary null hypothesis of this randomized trial was that there is no significant difference with respect to functional outcome, pain and disability between patients treated with either 2.4-mm volar locking plate fixation or intramedullary nail fixation of intra-articular fractures of the distal radius. Methods: We conducted a single-centre, prospective randomized matched-pairs trial. Patients with intraarticular distal radius fractures with metaphyseal comminution and a sagittal fracture line (AO 23 C2.1) were randomized to receive volar locking plate fixation (n = 14) or intramedullary nailing (n = 14). The outcome was measured on the basis of the Gartland and Werley and Castaing score; the pain level; the range of wrist motion; the rate of complications; and radiographic measurements including volar tilt and ulnar variance. Clinical and radiographic assessment was performed at 8 weeks and 2 years after the operation. Results: There were no significant differences between groups in terms of range of motion, grip strength or the level of pain at eight weeks. At the final follow up, patients in the nail group had regained more extension than in the plate group (98% of the unaffected side vs. 94%, this however, did not reach significance). Reduction was maintained in both groups; however volar tilt and ulnar variance were significantly better in the plate group. There was no significant difference in the complication rate between groups. Conclusion: The present study suggests that intramedullary nail fixation is a reasonable alternative to volar plate fixation for the treatment of intra-articular distal radius fractures and both techniques can yield reliably good results. © 2016 Elsevier Ltd. All rights reserved.
intramedullary technique prospective randomized trial
Introduction The goal of treatment for distal radius fractures is to obtain sufficient pain-free motion, allowing return to activities while minimizing the risk for future degenerative changes or disability [1]. Different techniques have been established over the years to achieve these goals. Despite numerous reports on the merits and disadvantages of each technique there remains a lack of robust clinical evidence to support any one intervention over another especially in certain subtypes of fracture [2,3]. Intramedullary techniques for fixation of distal radius fractures have been introduced. Purported benefits
* Corresponding author at: Georg Gradl, Department of Orthopaedic Trauma- and Reconstructive Surgery, Städt. Klinikum München GmbH, Krankenhaus München Harlaching, Sanato.riumsplatz 2, 81545 München, Germany. Tel.: +49-89-6210-2304; fax: +49-89-6210-2303. E-mail address: [email protected] (G. Gradl).
0020-1383 / © 2016 Elsevier Ltd. All rights reserved.
include limited soft tissue dissection, a low profile implant with less risk of soft tissue irritation, divergent subchondral screw placement, and locked fixed-angle fixation, affording sufficient stability to allow early wrist motion [4–6]. Initial results of intramedullary nail fixation have been previously published [4–6] but those studies contained relatively few patients, short follow-up periods, and or no comparison group. In addition, more complex fracture patterns have often been excluded and trials have focused on extraarticular or simple intraarticular fracture types [6,7]. Intraarticular distal radius fractures with metaphyseal comminution and a sagittal fracture line (AO 23 C2.1) are often amenable to closed reduction and less invasive treatment, e.g. non-bridging external fixation [8]. In more complex fractures with displacement of the intraarticular fragment open reduction and locking plate fixation is recommended [9]. A retrospective study however reported loss of reduction within the first six weeks after surgery in those fractures with a high degree of dorsal comminution such as C2 type fractures.
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G. Gradl et al. / Injury, Int. J. Care Injured 47S7 (2016) S25–S30
Palmar plate fixation might not be able to adequately address intraarticular fragments and maintain reduction. Less invasive intramedullary fixation with diverging screws that allow for fragment specific fixation might be a reasonable alternative in this specific fracture type. We therefore hypothesized that there is no significant difference in functional and radiological outcome of AO type C2.1 intraarticular fractures of the distal radius treated with either 2.4-mm volar locking plate fixation or intramedullary nail fixation (Targon DR). Material and methods Study design This was a single-centre prospective randomized matched pair trial. Patient selection Eligible participants were all adults aged 18 or over with AO type C2.1 intraarticular fractures of the distal radius. All patients were recruited at one single Level I trauma centre from September 2005 to June 2008. Institutional Review Board approval was granted before initiation of this study, and strict confidentiality guidelines were followed. All patients provided written informed consent at the time of enrolment. We paired participants by sex and age and randomly assigned them (computerized random numbers) to receive either plate fixation or intramedullary nailing. Patients were assigned sequentially numbered opaque, sealed and stapled envelopes to conceal allocation from the enrolling researcher. The researcher was not involved in patient treatment. The treating physicians opened corresponding envelopes at the preoperative visit only after the enrolled participants completed all baseline assessments.
Fig. 1. Fluoroscopic image confirming reduction and stable fixation with the intramedullary nail.
Volar plate fixation was performed through a standard Henry approach [10]. Once anatomic reduction was confirmed with fluoroscopy, fractures were temporarily fixed with a Kirschner wire inserted percutaneously through the radial styloid. We recorded operative time, fluoroscopy time and duration of hospital stay. Postoperative management
Treatment According to our hospital’s policies, all operations were performed as inpatient procedures in the operating room with the patient under regional or general anaesthesia.
Patients were not immobilized and were allowed immediate forearm, wrist, and finger motion. Formal therapy was individualized. Strenuous tasks, sports activity, and weight bearing were allowed once radiographs confirmed fracture union.
Operative technique
Functional assessment
Targon® DR Fixation was performed according to manufacturer guidelines A 4-cm skin incision was made from the tip of the radial styloid. Care was taken to identify and gently retract the radial sensory branches that cross the compartment obliquely by using gentle, blunt longitudinal dissection as soon as the deepest dermal layer of skin had been incised. The interval between the first and second dorsal compartments was developed subperiosteally. The fracture was reduced by insertion of a Kapandji wire under fluoroscopic control. Using the Kapandji wire as a guidewire, the intramedullary canal was opened with a cannulated reamer, followed by broaching of the medullary cavity, using the designated profilers. Once broaching and sizing were completed, the actual implant and insertion jig were assembled on the back table and inserted into the distal radius. After correct placement was confirmed, four 1.8 mm drilling wires were inserted through the insertion jig and replaced by fixation screws. Length, tilt and rotation were confirmed prior to insertion of the proximal bicortical locking screws. Final images were taken to confirm reduction and fixation of the fracture (Figure 1). After wound closure, a simple dressing was applied.
Follow-up was performed at 8 weeks, 6 months, 1 year and 2 years after the operation. All patients were evaluated by an independent investigator not involved in the patients’ treatment. Blinding of the investigator was not possible due to obvious differences in incision placement. Functional assessment included measurement of active range of wrist motion, using a goniometer. Grip power was measured with a dynamometer (Jamar; JA Preston Corp., Jackson, MI) at position 3, and an average of three trials. All clinical data were compared with the non-involved side. Wrist pain was evaluated using the visual analogue scale (VAS) (VAS 0 = no pain, VAS 10 = severe pain). Subjective and objective data were summarized in the Gartland and Werley Score (0–2 = excellent to >20 = poor) [11] and the Castaing Score (0 = perfect to >25 = very poor) which comprises wrist function and radiographic data [12]. Radiographic assessment Standard posterior-anterior and lateral wrist radiographs were obtained at each follow up visit. On lateral radiographs of the symptomatic wrist in the neutral position, volar tilt (number of degrees from the neutral position) of the articular surface of the distal
G. Gradl et al. / Injury, Int. J. Care Injured 47S7 (2016) S25–S30 Table 1. Demographic characteristics
Number of patients Age Gender Male Female Hand dominance Right Left Injured side Right Left Dominant side injured Yes No
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Table 2. Procedure time, fluoroscopy time and hospital stay Volar plate
Targon DR
14 63.8 ± 8.9
14 64.8 ± 11.6
2 12
2 12
14 0
14 0
5 9
4 10
5 9
4 10
*Values are given as mean and standard deviation.
radius was measured. On posteroanterior radiographs ulnar variance was measured as described by Medoff [13]. Fracture union was defined as bone bridging of the radial, ulnar, and dorsal cortical aspect of the distal radius as seen in anteroposterior and lateral projections within three months after surgery. Patients with incomplete callous bridging four months after surgery were considered to have delayed healing, and patients with limited radiographic evidence six months after surgery or initial injury were considered to have fracture nonunion [14]. Statistical analysis Descriptive statistics were computed for variables of interest. After testing for normality, non-parametric Mann-Whitney Test was chosen to assess differences between groups concerning the investigated continuous variables. Fisher’s exact test was used to assess differences for categorical variables. We used Bonferroni-correction, so the significance level of statistical tests was set at p = 0.038 for a twosided confidence level of 95%. Results Baseline data Table 1 summarizes the demographic characteristics of the patients. The mean time from injury to surgery was eight days (range, 1–24). Fractures were classified according to the AO/ASIF classification system by a single experienced orthopaedic surgeon.
Numbers analyzed The primary analysis was on-treatment and involved all patients who completed the final follow up. One patient did not attend the final follow up evaluation. Two patients died of unrelated conditions and were excluded. A total of 25 patients were available at the final follow up.
Procedure time (min) Fluoroscopy time (sec) Hospital stay (d)
Volar plate
Targon DR
p
60 (33–95) 1.8 (0.3–7) 4 (3–5)
54 (32–92) 3.15 (1–8) 4 (3–6)
0.402 0.062 0.352
Values are presented as median and range.
Table 3. Range of motion and Castaing Score at 8 weeks
Extension/Flexion Radial/Ulnar Deviation Pronation/Supination Castaing Score
Volar plate
Targon DR
p
80 ± 27 47 ± 14 157 ± 33 7±4
89 ± 18 56 ± 12 173 ± 7 3±3
0.171 0.222 0.347 0.091
Values are presented as mean ± standard deviation.
Clinical outcome Patients in both groups achieved 82% of wrist motion and grip strength of the unaffected side. After eight weeks, patients in the nail group presented with greater range of motion and lower Castaing scores, however this difference was not significant (Table 3). At the final follow up, active wrist extension recovery averaged 97% in the nail group and was greater than in the plate group (Table 4). More than 96% of patients in both groups showed perfect or good results according to the Castaing Score and excellent or good results according to the Gartland and Werley score. Patients in both group reported no or very mild pain (Table 5). Radiographic outcome All fractures united within three months after surgery. Reduction was maintained in all patients. Palmar tilt and ulnar variance were significantly better in the plate group (Table 6). Figures 2 and 3 show a typical case of intramedullary fixation. Complications and reoperations Complications were noted in three patients. Table 4. Range of motion and grip strength at 2 years
Extension Flexion Radial Deviation Ulnar Deviation Pronation Supination Grip strength
Volar plate
Targon DR
94 ± 8 89 ± 12 93 ± 9 91 ± 11 100 ± 0 99 ± 3 82 ± 17
97 ± 5 93 ± 9 91 ± 10 92 ± 11 100 ± 0 97 ± 7 87 ± 10
p 0.219 0.516 0.887 0.906 0.999 0.738 0.599
Values are presented as mean ± standard deviation in percentage of the unaffected side.
Table 5. Scores at 2 years
Treatment Median operative time was longer for plate fixation, whereas fluoroscopy time was higher for intramedullary nailing. Both differences were not significant ( p = 0.40 and 0.06 respectively). There was no significant difference between groups with respect to hospital stay ( p = 0.35) (Table 2).
Castaing Gartland VAS at rest VAS with activity
Volar Plate
Targon DR
p
1.44 ± 1.13 1.11 ± 1.83 0.00 ± 0.00 0.00 ± 0.00
1.55 ± 2.66 1.00 ± 1.48 0.00 ± 0.00 0.91 ± 2.21
0.41 0.99 0.99 0.48
Values are reported as mean ± standard deviation.
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G. Gradl et al. / Injury, Int. J. Care Injured 47S7 (2016) S25–S30 Table 6. Radiographic measurements at 2 years
Ulnar variance (mm) Volar tilt (degree)
Volar Plate
Targon DR
p
−0.4 ± 0.8 (−2 to 0) 5.5 ± 6.2 (0–15)
0.8 ± 0.9 (0–2) 0.0 ± 0.0 (0–0)
0.036* 0.003*
Values are reported as mean ± standard deviation; range in parentheses. *Indicating significance.
Implant removal due to screw penetration into the distal radioulnar joint was performed in one case in the nail group. One patient in each group reported persistent discomfort at the wrist and have had their implants removed. Implant removal was not performed routinely, but only at the patient’s request. Chronic or deep soft-tissue infections or tendon irritations were not detected in either group. Discussion
Fig. 2. Preoperative radiographs of a AO 23 C2.1 distal radius fracture in a 72-yearold lady.
One patient in the volar plate group developed symptoms of carpal tunnel syndrome and received implant removal and carpal tunnel release. Transient paraesthesia of the superficial radial nerve occurred in one patient in the nail group.
Stabilization of distal radius fractures constitute an important component of the daily work load of a trauma surgeon [15–19]. The present study prospectively evaluated the differences between 2.4-mm volar locking plate fixation and intramedullary nail fixation for a certain subtype (AO type C2.1) of intra-articular fracture of the distal radius. Our null hypothesis was that there would be no significant differences in any outcome between the two groups at eight weeks and two years after the operation. However, in the early recovery period, ulnar abduction seemed to be less compromised in the nailing group and patients had lower Castaing scores. At the time of the final follow up, active wrist extension recovery averaged 97% in the nail group and was greater than in the plate group, but did not reach a level of significance. Patients in both groups had regained more than 82% of wrist motion and grip strength compared to the unaffected side and reported no or only minimal pain. Comparison of the initial postoperative radiographs with those taken at the last follow-up showed only minimal loss of reduction during fracture healing in both groups. Ulnar variance and volar tilt were significantly worse in the nail group, however, this did not seem to affect functional outcome. Despite the fact that we selected only dorsally displaced fractures, there was only one case of late dorsal displacement and this occurred in both groups. The intramedullary device seems to provide sufficient stability to prevent secondary displacement as has been demonstrated in clinical and biomechanical studies [15–17,20–22]. In a prospective study evaluating the efficacy of 2.4 mm column-specific plating for intraarticular distal radius fractures in 105 patients with AO type C distal radius fractures, the authors found that the odds of a good reduction were 0.25 (0.077–0.83) for C2 fractures and 0.17 (0.05–0.53) for C3
Fig. 3. Left panel: Eight weeks after intramedullary nail fixation; right panel: two years after intramedullary nail fixation.
G. Gradl et al. / Injury, Int. J. Care Injured 47S7 (2016) S25–S30
fractures compared with the C1 subtype [23]. In a previous parallelgroup trial with patients with dorsally displaced extra-articular distal radius fractures, intramedullary fixation yielded similarly good results as volar plate fixation. At the time of the final follow up, patients in both groups had regained more than 82% of wrist motion and grip strength compared to the unaffected side and reported no or only minimal pain. Comparison of the initial postoperative radiographs with those taken at the last follow-up showed no loss of reduction during fracture healing [7]. Ilyas and Thoder presented their preliminary experience with an intramedullary Nail (Micronail) for displaced extraarticular and simple intraarticular distal radius fractures (AO type A and C1) [6]. The average age of the ten patients was 55 years, and average follow-up was 21 months. Similar to our findings, they found transient radial nerve disturbance in 20% of cases and implant related complications in 30%. Grip strength was 91% of the uninjured side and the mean DASH score was 2.7 points. They experienced three cases of screw penetration into the DRUJ on final follow-up radiographs, one of which was symptomatic and presented with DRUJ arthritis. Loss of reduction at final follow up as determined by a difference of greater than 5° between immediate postoperative and final radiographs occurred in two patients. Interestingly enough, both cases represented AO type A3 fractures. The authors specifically avoided use of the Micronail for all AO type B and C2 or C3 fractures in their study and concluded good outcomes could be obtained with intramedullary fixation of extra-articular and simple intraarticular fracture patterns. In a prospective study, Tan et al. [4] reported on 23 consecutive patients with unstable distal radius fractures treated with an intramedullary nail. At the 6-month follow-up, flexion averaged 58° (range, 25–75°), extension 73° (range, 55–90°), radial deviation 22° (range, 15–30°), ulnar deviation 28° (range, 20–35°), supination 78° (range, 50– 90°) and pronation 87° (range, 80–90°). The mean grip strength was 80% (range, 68–100%) of the uninjured side. Comparison of the initial postoperative radiographs with those taken at the latest follow-up showed complete reduction was maintained in all but three patients. Two of these had AO type C2 fractures. The investigators attribute this to diminished dorsal-volar divergence of the distal screws in the firstgeneration design of the device. Nishiwaki et al. [20] performed a prospective study on 29 patients with 25 AO type A and 5 AO type C fractures. After 12 months, patients had regained 90% of motion of the uninjured side and the results were rated as excellent in 20 cases, and good in 9 cases according to the modified Mayo Wrist Score. They reported loss of reduction in two cases, and transient radial sensory nerve neuritis in one case. The intramedullary implant appeared to avoid some of the soft tissue injuries, such as tendon irritation or rupture that can result with traditional plating. However, there is considerable risk of articular surface screw penetration, as evidenced in one of our cases, specifically of the DRUJ. One patient had temporary minor radial sensory nerve disturbance that resolved within 2 months of surgery. Insertion of the nail through the radial styloid places the superficial radial sensory nerve at risk and diligent identification and protection of the radial sensory nerve is required. Arora et al. reported a 27% complication rate in their study on 141 patients with distal radius fractures treated with volar plating. The most frequent problems were flexor and extensor tendon irritation (57%) followed by complex regional pain syndrome and carpal tunnel syndrome [9]. Due to the less direct exposure and indirect reduction technique, requiring frequent fluoroscopic controls, higher fluoroscopy times were needed to position the Targon DR nail. Median operative time however was shorter than in the plate group.
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A prospective randomized pilot study reported experience and early results with an intramedullary wrist pin in the treatment of extraarticular and simple intra-articular distal radius fractures. At the time of the final follow up the authors found no significant differences between groups with regard to wrist motion and radiographic parameters. Mean operative time was significantly shorter in the nail group. The authors concluded that intramedullary fixation is reliable and effective and prevents complications that are related to extensive soft tissue dissection [24]. There are several limitations to our study. First, functional and radiographic assessment could not be blinded due to obvious placement of surgical incisions and implants visible on radiographs. Second, a relatively small number of patients were enrolled in this study due to the limited inclusion criteria (specific fracture type). Third, we did not use any patient reported outcome measures and did not address the patients’ perspective. Despite these shortcomings, the present study suggests that intramedullary nail fixation is a reasonable alternative to volar plate fixation for the treatment of displaced intraarticular distal radius fractures. Extraarticular and simple intraarticular fractures however might yield more reliable results in terms of maintenance of reduction. Conflict of interest None References [1] Ilyas AM, Jupiter JB. Distal radius fractures – classification of treatment and indications for surgery. Orthop Clin North Am 2007;38:167–73. [2] Handoll HH, Madhok R. Surgical interventions for treating distal radial fractures in adults. Cochrane Database Syst Rev 2003:CD003209. [3] Fanuele J, Koval KJ, Lurie J, Zhou W, Tosteson A, Ring D, et al. Distal radial fracture treatment: what you get may depend on your age and address. J Bone Joint Surg Am 2009;91:1313–9. [4] Tan V, Capo J, Warburton M. Distal radius fracture fixation with an intramedullary nail. Tech Hand Up Extrem Surg 2005;9:195–201. [5] Brooks KR, Capo JT, Warburton M, Tan V. Internal fixation of distal radius fractures with novel intramedullary implants. Clin Orthop Relat Res 2006;445:42–50. [6] Ilyas AM, Thoder JJ. Intramedullary fixation of displaced distal radius fractures: a preliminary report. J Hand Surg Am 2008;33:1706–15. [7] Gradl G, Mielsch N, Wendt M, Falk S, Mittlmeier T, Gierer P. Intramedullary nail versus volar plate fixation of extra-articular distal radius fractures. Two year results of a prospective randomized trial. Injury 2013;45(Suppl 1):S3–8. [8] Gradl G, Wendt M, Mittlmeier T, Kundt G, Jupiter JB. Non-bridging external fixation employing multiplanar K-wires versus volar locked plating for dorsally displaced fractures of the distal radius. Arch Orthop Trauma Surg 2013;133:595–602. [9] Arora R, Lutz M, Hennerbichler A, Krappinger D, Espen D, Gabl M, et al. Complications following internal fixation of unstable distal radius fracture with a palmar locking-plate. J Orthop Trauma 2007;21:316–22. [10] Protopsaltis TS, Ruch DS. Volar approach to distal radius fractures. J Hand Surg Am 2008;33:958–65. [11] Gartland JJ, Jr, Werley CW. Evaluation of healed Colles’ fractures. J Bone Joint Surg Am 1951;33-A:895–907. [12] Castaing J. Recent fractures of the lower extremity of the radius in adults. Rev Chir Orthop Reparatrice Appar Mot 1964;50:581–696. [13] Medoff RJ. Essential radiographic evaluation for distal radius fractures. Hand Clin 2005;21:279–88. [14] Fernandez DL, Ring D, Jupiter JB. Surgical management of delayed union and nonunion of distal radius fractures. J Hand Surg Am 2001;26:201–9. [15] Vanhaecke J, Fernandez DL. DVR plating of distal radius fractures. Injury 2015;46 (Suppl 5):S33–6. [16] Dario P, Matteo G, Carolina C, Marco G, Cristina D, Daniele F, et al. Is it really necessary to restore radial anatomic parameters after distal radius fractures? Injury 2014;45(Suppl 6): S21–6. [17] Wijffels MM, Keizer J, Buijze GA, Zenke Y, Krijnen P, Schep NW, Schipper IB, et al. Ulnar styloid process nonunion and outcome in patients with a distal radius fracture: a metaanalysis of comparative clinical trials. Injury 2014;45:1889–95. [18] Arealis G, Galanopoulos I, Nikolaou VS, Lacon A, Ashwood N, Kitsis C, et al. Does the CT improve inter- and intra-observer agreement for the AO, Fernandez and Universal classification systems for distal radius fractures? Injury 2014;45:1579–84. [19] Selvan DR, Perry D, Machin DG, Brown DJ. The role of post-operative radiographs in predicting risk of flexor pollicis longus tendon rupture after volar plate fixation of distal radius fractures – a case control study. Injury 2014;45:1885–8. [20] Nishiwaki M, Tazaki K, Shimizu H, Ilyas AM. Prospective study of distal radial fractures treated with an intramedullary nail. J Bone Joint Surg Am 2011;93:1436–41.
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[21] Burkhart KJ, Nowak TE, Gradl G, Klitscher D, Mehling I, Mehler D, et al. Intramedullary nailing vs. palmar locked plating for unstable dorsally comminuted distal radius fractures: a biomechanical study. Clin Biomech (Bristol, Avon) 2010;25:771–5. [22] Capo JT, Kinchelow T, Brooks K, Tan V, Manigrasso M, Francisco K, et al. Biomechanical stability of four fixation constructs for distal radius fractures. Hand (N Y) 2009;4:272–8.
[23] Gavaskar AS, Muthukumar S, Chowdary N. Fragment-specific fixation for complex intraarticular fractures of the distal radius: results of a prospective single-centre trial. J Hand Surg Eur Vol 2012;37:765–71. [24] Zehir S, Calbiyik M, Zehir R, Ipek D. Intramedullary repair device against volar plating in the reconstruction of extra-articular and simple articular distal radius fractures; a randomized pilot study. Int Orthop 2014;38:1655–60.
Contents lists available at ScienceDirect
Injury j o u r n a l h o m e p a g e : w w w. e l s e v i e r . c o m / l o c at e / I n j u r y
Fixation of intra-articular fractures of the distal radius using intramedullary nailing: a randomized trial versus palmar locking plates Gertraud Gradla, Steffi Falkb, Thomas Mittlmeierb, Martina Wendtb, Nadja Mielschb, Georg Gradlc,* a
Department of Trauma and Reconstructive Surgery, Aachen University Medical Center, Pauwelstrasse 30, 52074 Aachen, Germany Department of Trauma- and Reconstructive Surgery, Surgical Clinic University of Rostock, Schillingallee 35, 18055 Rostock, Germany Clinic for Trauma Surgery, Orthopedic Surgery and Reconstructive Surgery, Munich Municipal Hospital Group, Sanatoriumsplatz 2, 81545 München, Germany
b c
K E Y W O R D S
A B S T R A C T
intraarticular distal radius fracture
Background: Proposed benefits of intramedullary techniques include limited soft tissue dissection while affording sufficient stability to allow early wrist motion. The primary null hypothesis of this randomized trial was that there is no significant difference with respect to functional outcome, pain and disability between patients treated with either 2.4-mm volar locking plate fixation or intramedullary nail fixation of intra-articular fractures of the distal radius. Methods: We conducted a single-centre, prospective randomized matched-pairs trial. Patients with intraarticular distal radius fractures with metaphyseal comminution and a sagittal fracture line (AO 23 C2.1) were randomized to receive volar locking plate fixation (n = 14) or intramedullary nailing (n = 14). The outcome was measured on the basis of the Gartland and Werley and Castaing score; the pain level; the range of wrist motion; the rate of complications; and radiographic measurements including volar tilt and ulnar variance. Clinical and radiographic assessment was performed at 8 weeks and 2 years after the operation. Results: There were no significant differences between groups in terms of range of motion, grip strength or the level of pain at eight weeks. At the final follow up, patients in the nail group had regained more extension than in the plate group (98% of the unaffected side vs. 94%, this however, did not reach significance). Reduction was maintained in both groups; however volar tilt and ulnar variance were significantly better in the plate group. There was no significant difference in the complication rate between groups. Conclusion: The present study suggests that intramedullary nail fixation is a reasonable alternative to volar plate fixation for the treatment of intra-articular distal radius fractures and both techniques can yield reliably good results. © 2016 Elsevier Ltd. All rights reserved.
intramedullary technique prospective randomized trial
Introduction The goal of treatment for distal radius fractures is to obtain sufficient pain-free motion, allowing return to activities while minimizing the risk for future degenerative changes or disability [1]. Different techniques have been established over the years to achieve these goals. Despite numerous reports on the merits and disadvantages of each technique there remains a lack of robust clinical evidence to support any one intervention over another especially in certain subtypes of fracture [2,3]. Intramedullary techniques for fixation of distal radius fractures have been introduced. Purported benefits
* Corresponding author at: Georg Gradl, Department of Orthopaedic Trauma- and Reconstructive Surgery, Städt. Klinikum München GmbH, Krankenhaus München Harlaching, Sanato.riumsplatz 2, 81545 München, Germany. Tel.: +49-89-6210-2304; fax: +49-89-6210-2303. E-mail address: [email protected] (G. Gradl).
0020-1383 / © 2016 Elsevier Ltd. All rights reserved.
include limited soft tissue dissection, a low profile implant with less risk of soft tissue irritation, divergent subchondral screw placement, and locked fixed-angle fixation, affording sufficient stability to allow early wrist motion [4–6]. Initial results of intramedullary nail fixation have been previously published [4–6] but those studies contained relatively few patients, short follow-up periods, and or no comparison group. In addition, more complex fracture patterns have often been excluded and trials have focused on extraarticular or simple intraarticular fracture types [6,7]. Intraarticular distal radius fractures with metaphyseal comminution and a sagittal fracture line (AO 23 C2.1) are often amenable to closed reduction and less invasive treatment, e.g. non-bridging external fixation [8]. In more complex fractures with displacement of the intraarticular fragment open reduction and locking plate fixation is recommended [9]. A retrospective study however reported loss of reduction within the first six weeks after surgery in those fractures with a high degree of dorsal comminution such as C2 type fractures.
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G. Gradl et al. / Injury, Int. J. Care Injured 47S7 (2016) S25–S30
Palmar plate fixation might not be able to adequately address intraarticular fragments and maintain reduction. Less invasive intramedullary fixation with diverging screws that allow for fragment specific fixation might be a reasonable alternative in this specific fracture type. We therefore hypothesized that there is no significant difference in functional and radiological outcome of AO type C2.1 intraarticular fractures of the distal radius treated with either 2.4-mm volar locking plate fixation or intramedullary nail fixation (Targon DR). Material and methods Study design This was a single-centre prospective randomized matched pair trial. Patient selection Eligible participants were all adults aged 18 or over with AO type C2.1 intraarticular fractures of the distal radius. All patients were recruited at one single Level I trauma centre from September 2005 to June 2008. Institutional Review Board approval was granted before initiation of this study, and strict confidentiality guidelines were followed. All patients provided written informed consent at the time of enrolment. We paired participants by sex and age and randomly assigned them (computerized random numbers) to receive either plate fixation or intramedullary nailing. Patients were assigned sequentially numbered opaque, sealed and stapled envelopes to conceal allocation from the enrolling researcher. The researcher was not involved in patient treatment. The treating physicians opened corresponding envelopes at the preoperative visit only after the enrolled participants completed all baseline assessments.
Fig. 1. Fluoroscopic image confirming reduction and stable fixation with the intramedullary nail.
Volar plate fixation was performed through a standard Henry approach [10]. Once anatomic reduction was confirmed with fluoroscopy, fractures were temporarily fixed with a Kirschner wire inserted percutaneously through the radial styloid. We recorded operative time, fluoroscopy time and duration of hospital stay. Postoperative management
Treatment According to our hospital’s policies, all operations were performed as inpatient procedures in the operating room with the patient under regional or general anaesthesia.
Patients were not immobilized and were allowed immediate forearm, wrist, and finger motion. Formal therapy was individualized. Strenuous tasks, sports activity, and weight bearing were allowed once radiographs confirmed fracture union.
Operative technique
Functional assessment
Targon® DR Fixation was performed according to manufacturer guidelines A 4-cm skin incision was made from the tip of the radial styloid. Care was taken to identify and gently retract the radial sensory branches that cross the compartment obliquely by using gentle, blunt longitudinal dissection as soon as the deepest dermal layer of skin had been incised. The interval between the first and second dorsal compartments was developed subperiosteally. The fracture was reduced by insertion of a Kapandji wire under fluoroscopic control. Using the Kapandji wire as a guidewire, the intramedullary canal was opened with a cannulated reamer, followed by broaching of the medullary cavity, using the designated profilers. Once broaching and sizing were completed, the actual implant and insertion jig were assembled on the back table and inserted into the distal radius. After correct placement was confirmed, four 1.8 mm drilling wires were inserted through the insertion jig and replaced by fixation screws. Length, tilt and rotation were confirmed prior to insertion of the proximal bicortical locking screws. Final images were taken to confirm reduction and fixation of the fracture (Figure 1). After wound closure, a simple dressing was applied.
Follow-up was performed at 8 weeks, 6 months, 1 year and 2 years after the operation. All patients were evaluated by an independent investigator not involved in the patients’ treatment. Blinding of the investigator was not possible due to obvious differences in incision placement. Functional assessment included measurement of active range of wrist motion, using a goniometer. Grip power was measured with a dynamometer (Jamar; JA Preston Corp., Jackson, MI) at position 3, and an average of three trials. All clinical data were compared with the non-involved side. Wrist pain was evaluated using the visual analogue scale (VAS) (VAS 0 = no pain, VAS 10 = severe pain). Subjective and objective data were summarized in the Gartland and Werley Score (0–2 = excellent to >20 = poor) [11] and the Castaing Score (0 = perfect to >25 = very poor) which comprises wrist function and radiographic data [12]. Radiographic assessment Standard posterior-anterior and lateral wrist radiographs were obtained at each follow up visit. On lateral radiographs of the symptomatic wrist in the neutral position, volar tilt (number of degrees from the neutral position) of the articular surface of the distal
G. Gradl et al. / Injury, Int. J. Care Injured 47S7 (2016) S25–S30 Table 1. Demographic characteristics
Number of patients Age Gender Male Female Hand dominance Right Left Injured side Right Left Dominant side injured Yes No
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Table 2. Procedure time, fluoroscopy time and hospital stay Volar plate
Targon DR
14 63.8 ± 8.9
14 64.8 ± 11.6
2 12
2 12
14 0
14 0
5 9
4 10
5 9
4 10
*Values are given as mean and standard deviation.
radius was measured. On posteroanterior radiographs ulnar variance was measured as described by Medoff [13]. Fracture union was defined as bone bridging of the radial, ulnar, and dorsal cortical aspect of the distal radius as seen in anteroposterior and lateral projections within three months after surgery. Patients with incomplete callous bridging four months after surgery were considered to have delayed healing, and patients with limited radiographic evidence six months after surgery or initial injury were considered to have fracture nonunion [14]. Statistical analysis Descriptive statistics were computed for variables of interest. After testing for normality, non-parametric Mann-Whitney Test was chosen to assess differences between groups concerning the investigated continuous variables. Fisher’s exact test was used to assess differences for categorical variables. We used Bonferroni-correction, so the significance level of statistical tests was set at p = 0.038 for a twosided confidence level of 95%. Results Baseline data Table 1 summarizes the demographic characteristics of the patients. The mean time from injury to surgery was eight days (range, 1–24). Fractures were classified according to the AO/ASIF classification system by a single experienced orthopaedic surgeon.
Numbers analyzed The primary analysis was on-treatment and involved all patients who completed the final follow up. One patient did not attend the final follow up evaluation. Two patients died of unrelated conditions and were excluded. A total of 25 patients were available at the final follow up.
Procedure time (min) Fluoroscopy time (sec) Hospital stay (d)
Volar plate
Targon DR
p
60 (33–95) 1.8 (0.3–7) 4 (3–5)
54 (32–92) 3.15 (1–8) 4 (3–6)
0.402 0.062 0.352
Values are presented as median and range.
Table 3. Range of motion and Castaing Score at 8 weeks
Extension/Flexion Radial/Ulnar Deviation Pronation/Supination Castaing Score
Volar plate
Targon DR
p
80 ± 27 47 ± 14 157 ± 33 7±4
89 ± 18 56 ± 12 173 ± 7 3±3
0.171 0.222 0.347 0.091
Values are presented as mean ± standard deviation.
Clinical outcome Patients in both groups achieved 82% of wrist motion and grip strength of the unaffected side. After eight weeks, patients in the nail group presented with greater range of motion and lower Castaing scores, however this difference was not significant (Table 3). At the final follow up, active wrist extension recovery averaged 97% in the nail group and was greater than in the plate group (Table 4). More than 96% of patients in both groups showed perfect or good results according to the Castaing Score and excellent or good results according to the Gartland and Werley score. Patients in both group reported no or very mild pain (Table 5). Radiographic outcome All fractures united within three months after surgery. Reduction was maintained in all patients. Palmar tilt and ulnar variance were significantly better in the plate group (Table 6). Figures 2 and 3 show a typical case of intramedullary fixation. Complications and reoperations Complications were noted in three patients. Table 4. Range of motion and grip strength at 2 years
Extension Flexion Radial Deviation Ulnar Deviation Pronation Supination Grip strength
Volar plate
Targon DR
94 ± 8 89 ± 12 93 ± 9 91 ± 11 100 ± 0 99 ± 3 82 ± 17
97 ± 5 93 ± 9 91 ± 10 92 ± 11 100 ± 0 97 ± 7 87 ± 10
p 0.219 0.516 0.887 0.906 0.999 0.738 0.599
Values are presented as mean ± standard deviation in percentage of the unaffected side.
Table 5. Scores at 2 years
Treatment Median operative time was longer for plate fixation, whereas fluoroscopy time was higher for intramedullary nailing. Both differences were not significant ( p = 0.40 and 0.06 respectively). There was no significant difference between groups with respect to hospital stay ( p = 0.35) (Table 2).
Castaing Gartland VAS at rest VAS with activity
Volar Plate
Targon DR
p
1.44 ± 1.13 1.11 ± 1.83 0.00 ± 0.00 0.00 ± 0.00
1.55 ± 2.66 1.00 ± 1.48 0.00 ± 0.00 0.91 ± 2.21
0.41 0.99 0.99 0.48
Values are reported as mean ± standard deviation.
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G. Gradl et al. / Injury, Int. J. Care Injured 47S7 (2016) S25–S30 Table 6. Radiographic measurements at 2 years
Ulnar variance (mm) Volar tilt (degree)
Volar Plate
Targon DR
p
−0.4 ± 0.8 (−2 to 0) 5.5 ± 6.2 (0–15)
0.8 ± 0.9 (0–2) 0.0 ± 0.0 (0–0)
0.036* 0.003*
Values are reported as mean ± standard deviation; range in parentheses. *Indicating significance.
Implant removal due to screw penetration into the distal radioulnar joint was performed in one case in the nail group. One patient in each group reported persistent discomfort at the wrist and have had their implants removed. Implant removal was not performed routinely, but only at the patient’s request. Chronic or deep soft-tissue infections or tendon irritations were not detected in either group. Discussion
Fig. 2. Preoperative radiographs of a AO 23 C2.1 distal radius fracture in a 72-yearold lady.
One patient in the volar plate group developed symptoms of carpal tunnel syndrome and received implant removal and carpal tunnel release. Transient paraesthesia of the superficial radial nerve occurred in one patient in the nail group.
Stabilization of distal radius fractures constitute an important component of the daily work load of a trauma surgeon [15–19]. The present study prospectively evaluated the differences between 2.4-mm volar locking plate fixation and intramedullary nail fixation for a certain subtype (AO type C2.1) of intra-articular fracture of the distal radius. Our null hypothesis was that there would be no significant differences in any outcome between the two groups at eight weeks and two years after the operation. However, in the early recovery period, ulnar abduction seemed to be less compromised in the nailing group and patients had lower Castaing scores. At the time of the final follow up, active wrist extension recovery averaged 97% in the nail group and was greater than in the plate group, but did not reach a level of significance. Patients in both groups had regained more than 82% of wrist motion and grip strength compared to the unaffected side and reported no or only minimal pain. Comparison of the initial postoperative radiographs with those taken at the last follow-up showed only minimal loss of reduction during fracture healing in both groups. Ulnar variance and volar tilt were significantly worse in the nail group, however, this did not seem to affect functional outcome. Despite the fact that we selected only dorsally displaced fractures, there was only one case of late dorsal displacement and this occurred in both groups. The intramedullary device seems to provide sufficient stability to prevent secondary displacement as has been demonstrated in clinical and biomechanical studies [15–17,20–22]. In a prospective study evaluating the efficacy of 2.4 mm column-specific plating for intraarticular distal radius fractures in 105 patients with AO type C distal radius fractures, the authors found that the odds of a good reduction were 0.25 (0.077–0.83) for C2 fractures and 0.17 (0.05–0.53) for C3
Fig. 3. Left panel: Eight weeks after intramedullary nail fixation; right panel: two years after intramedullary nail fixation.
G. Gradl et al. / Injury, Int. J. Care Injured 47S7 (2016) S25–S30
fractures compared with the C1 subtype [23]. In a previous parallelgroup trial with patients with dorsally displaced extra-articular distal radius fractures, intramedullary fixation yielded similarly good results as volar plate fixation. At the time of the final follow up, patients in both groups had regained more than 82% of wrist motion and grip strength compared to the unaffected side and reported no or only minimal pain. Comparison of the initial postoperative radiographs with those taken at the last follow-up showed no loss of reduction during fracture healing [7]. Ilyas and Thoder presented their preliminary experience with an intramedullary Nail (Micronail) for displaced extraarticular and simple intraarticular distal radius fractures (AO type A and C1) [6]. The average age of the ten patients was 55 years, and average follow-up was 21 months. Similar to our findings, they found transient radial nerve disturbance in 20% of cases and implant related complications in 30%. Grip strength was 91% of the uninjured side and the mean DASH score was 2.7 points. They experienced three cases of screw penetration into the DRUJ on final follow-up radiographs, one of which was symptomatic and presented with DRUJ arthritis. Loss of reduction at final follow up as determined by a difference of greater than 5° between immediate postoperative and final radiographs occurred in two patients. Interestingly enough, both cases represented AO type A3 fractures. The authors specifically avoided use of the Micronail for all AO type B and C2 or C3 fractures in their study and concluded good outcomes could be obtained with intramedullary fixation of extra-articular and simple intraarticular fracture patterns. In a prospective study, Tan et al. [4] reported on 23 consecutive patients with unstable distal radius fractures treated with an intramedullary nail. At the 6-month follow-up, flexion averaged 58° (range, 25–75°), extension 73° (range, 55–90°), radial deviation 22° (range, 15–30°), ulnar deviation 28° (range, 20–35°), supination 78° (range, 50– 90°) and pronation 87° (range, 80–90°). The mean grip strength was 80% (range, 68–100%) of the uninjured side. Comparison of the initial postoperative radiographs with those taken at the latest follow-up showed complete reduction was maintained in all but three patients. Two of these had AO type C2 fractures. The investigators attribute this to diminished dorsal-volar divergence of the distal screws in the firstgeneration design of the device. Nishiwaki et al. [20] performed a prospective study on 29 patients with 25 AO type A and 5 AO type C fractures. After 12 months, patients had regained 90% of motion of the uninjured side and the results were rated as excellent in 20 cases, and good in 9 cases according to the modified Mayo Wrist Score. They reported loss of reduction in two cases, and transient radial sensory nerve neuritis in one case. The intramedullary implant appeared to avoid some of the soft tissue injuries, such as tendon irritation or rupture that can result with traditional plating. However, there is considerable risk of articular surface screw penetration, as evidenced in one of our cases, specifically of the DRUJ. One patient had temporary minor radial sensory nerve disturbance that resolved within 2 months of surgery. Insertion of the nail through the radial styloid places the superficial radial sensory nerve at risk and diligent identification and protection of the radial sensory nerve is required. Arora et al. reported a 27% complication rate in their study on 141 patients with distal radius fractures treated with volar plating. The most frequent problems were flexor and extensor tendon irritation (57%) followed by complex regional pain syndrome and carpal tunnel syndrome [9]. Due to the less direct exposure and indirect reduction technique, requiring frequent fluoroscopic controls, higher fluoroscopy times were needed to position the Targon DR nail. Median operative time however was shorter than in the plate group.
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A prospective randomized pilot study reported experience and early results with an intramedullary wrist pin in the treatment of extraarticular and simple intra-articular distal radius fractures. At the time of the final follow up the authors found no significant differences between groups with regard to wrist motion and radiographic parameters. Mean operative time was significantly shorter in the nail group. The authors concluded that intramedullary fixation is reliable and effective and prevents complications that are related to extensive soft tissue dissection [24]. There are several limitations to our study. First, functional and radiographic assessment could not be blinded due to obvious placement of surgical incisions and implants visible on radiographs. Second, a relatively small number of patients were enrolled in this study due to the limited inclusion criteria (specific fracture type). Third, we did not use any patient reported outcome measures and did not address the patients’ perspective. Despite these shortcomings, the present study suggests that intramedullary nail fixation is a reasonable alternative to volar plate fixation for the treatment of displaced intraarticular distal radius fractures. Extraarticular and simple intraarticular fractures however might yield more reliable results in terms of maintenance of reduction. Conflict of interest None References [1] Ilyas AM, Jupiter JB. Distal radius fractures – classification of treatment and indications for surgery. Orthop Clin North Am 2007;38:167–73. [2] Handoll HH, Madhok R. Surgical interventions for treating distal radial fractures in adults. Cochrane Database Syst Rev 2003:CD003209. [3] Fanuele J, Koval KJ, Lurie J, Zhou W, Tosteson A, Ring D, et al. Distal radial fracture treatment: what you get may depend on your age and address. J Bone Joint Surg Am 2009;91:1313–9. [4] Tan V, Capo J, Warburton M. Distal radius fracture fixation with an intramedullary nail. Tech Hand Up Extrem Surg 2005;9:195–201. [5] Brooks KR, Capo JT, Warburton M, Tan V. Internal fixation of distal radius fractures with novel intramedullary implants. Clin Orthop Relat Res 2006;445:42–50. [6] Ilyas AM, Thoder JJ. Intramedullary fixation of displaced distal radius fractures: a preliminary report. J Hand Surg Am 2008;33:1706–15. [7] Gradl G, Mielsch N, Wendt M, Falk S, Mittlmeier T, Gierer P. Intramedullary nail versus volar plate fixation of extra-articular distal radius fractures. Two year results of a prospective randomized trial. Injury 2013;45(Suppl 1):S3–8. [8] Gradl G, Wendt M, Mittlmeier T, Kundt G, Jupiter JB. Non-bridging external fixation employing multiplanar K-wires versus volar locked plating for dorsally displaced fractures of the distal radius. Arch Orthop Trauma Surg 2013;133:595–602. [9] Arora R, Lutz M, Hennerbichler A, Krappinger D, Espen D, Gabl M, et al. Complications following internal fixation of unstable distal radius fracture with a palmar locking-plate. J Orthop Trauma 2007;21:316–22. [10] Protopsaltis TS, Ruch DS. Volar approach to distal radius fractures. J Hand Surg Am 2008;33:958–65. [11] Gartland JJ, Jr, Werley CW. Evaluation of healed Colles’ fractures. J Bone Joint Surg Am 1951;33-A:895–907. [12] Castaing J. Recent fractures of the lower extremity of the radius in adults. Rev Chir Orthop Reparatrice Appar Mot 1964;50:581–696. [13] Medoff RJ. Essential radiographic evaluation for distal radius fractures. Hand Clin 2005;21:279–88. [14] Fernandez DL, Ring D, Jupiter JB. Surgical management of delayed union and nonunion of distal radius fractures. J Hand Surg Am 2001;26:201–9. [15] Vanhaecke J, Fernandez DL. DVR plating of distal radius fractures. Injury 2015;46 (Suppl 5):S33–6. [16] Dario P, Matteo G, Carolina C, Marco G, Cristina D, Daniele F, et al. Is it really necessary to restore radial anatomic parameters after distal radius fractures? Injury 2014;45(Suppl 6): S21–6. [17] Wijffels MM, Keizer J, Buijze GA, Zenke Y, Krijnen P, Schep NW, Schipper IB, et al. Ulnar styloid process nonunion and outcome in patients with a distal radius fracture: a metaanalysis of comparative clinical trials. Injury 2014;45:1889–95. [18] Arealis G, Galanopoulos I, Nikolaou VS, Lacon A, Ashwood N, Kitsis C, et al. Does the CT improve inter- and intra-observer agreement for the AO, Fernandez and Universal classification systems for distal radius fractures? Injury 2014;45:1579–84. [19] Selvan DR, Perry D, Machin DG, Brown DJ. The role of post-operative radiographs in predicting risk of flexor pollicis longus tendon rupture after volar plate fixation of distal radius fractures – a case control study. Injury 2014;45:1885–8. [20] Nishiwaki M, Tazaki K, Shimizu H, Ilyas AM. Prospective study of distal radial fractures treated with an intramedullary nail. J Bone Joint Surg Am 2011;93:1436–41.
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