Dehghan N, McKee MD, Jenkinson RJ, Schemitsch EH, Stas V, Nauth A, Hall JA, Stephen DJ, Kreder HJ. Early weightbearing and range of motion versus non-weightbearing and immobilization after open reduction and internal fixation of unstable ankle fractures: a randomized controlled trial. J Orthop Trauma. 2016 Jul;30(7):345-52.
In patients who had surgical fixation of unstable ankle fractures, how do early and late weight-bearing and range-of-motion exercise compare for return to work and function?
Randomized (allocation concealed), unblinded, controlled trial with 12 months of follow-up.
2 trauma centers in Toronto, Ontario, Canada.
110 patients (mean age, 42 years; 54% men) who had isolated, acute, unstable ankle fractures that were treated with stable internal fixation. Exclusion criteria were syndesmotic injuries, posterior malleolar fractures needing fixation, surgical fixation >14 days after injury, grade-III open fractures, tibial plafond fractures, polytrauma, skeletal immaturity, past ipsilateral ankle surgery, nonambulatory status before injury, inability to participate in the intervention or study protocol, or receipt of Workers’ Compensation. 82% of patients provided data for the primary outcome, and ≥84% provided other data at each assessment.
Patients were allocated to early (n = 56) or late (n = 54) weight-bearing and range-of-motion exercise under the direction of physiotherapists. All patients underwent open reduction and internal fixation with rigid osteosynthesis techniques, were immobilized for 2 weeks in a below-the-knee posterior plaster slab, and were restricted from bearing weight. Patients in the early group were provided with a boot orthosis and were advised to begin weight-bearing as tolerated at 2 weeks postoperatively. They were instructed to remove the orthosis 4 times/day and to perform ankle dorsiflexion, plantar flexion, inversion, and eversion exercises. At 6 weeks, they were advised to wean from the boot orthosis over the next 2 to 4 weeks. Patients in the late group were provided with a below-the-knee fiberglass cast at 2 weeks postoperatively and were advised to remain non-weight-bearing for 4 additional weeks (total, 6 weeks). At 6 weeks, they were provided with a boot orthosis and were advised to begin weight-bearing as tolerated, to perform ankle range-of-motion exercises, and to wean from the boot orthosis over 2 to 4 weeks.
Main outcome measures:
The primary outcome was time to return to work. Secondary outcomes included ankle range of motion, ankle function (Olerud-Molander ankle function score), physical and mental health outcomes (Short Form-36 [SF-36] Health Survey), and complications.
Analysis was by intention to treat. 106 patients were needed to have 80% power to detect an 11-day difference in time to return to work (α = 0.05). The early and late groups did not differ in terms of the total number of days off work (mean, 51 vs. 48 days; p = 0.72). At 6 weeks after surgery, the early group had better ankle range of motion (mean, 41° vs. 29°; p < 0.0001), Olerud-Molander ankle function scores (mean, 45 vs. 32; p = 0.0007), and SF-36 scores in terms of both the physical (mean, 51 vs. 42; p = 0.008) and mental (mean, 66 vs. 54; p = 0.0008) components. Outcomes did not differ between the 2 groups beyond 6 weeks, except for higher physical SF-36 scores in the early group at 12 months (mean, 85 vs. 79; p = 0.04). There were no differences between the groups in terms of wound complications, surgical site infections, or loss of fixation or reduction. The late group had a higher rate of reoperations for implant removal than the early group (19% vs. 2%; p = 0.005).
In patients who had surgical fixation of unstable ankle fractures, early compared with late weight-bearing and range-of-motion exercises did not affect time to return to work or most measures of long-term function and did not increase complications. Early weight-bearing and range of motion improved early function and reduced reoperations for hardware removal.
Sources of funding:
Orthopaedic Trauma Association; Physician Services, Inc.; Canadian Orthopaedic Association; Canadian Orthopaedic Trauma Society.
For correspondence: Dr. N. Dehghan, 55 Queen St. E., Suite 800, Toronto, ON M5C 1R6, Canada. E-mail address: email@example.com.
The randomized trial by Dehghan and colleagues showed that, for surgically treated isolated ankle fractures that did not require fixation of the syndesmosis or posterior malleolus, early weight-bearing and range of motion caused neither higher wound-complication rates nor higher fracture-displacement rates. The presence or absence of diabetes was not reported.
The trial did not support the hypothesis that the early protocol would be associated with an earlier return to work. Although return to work is an important outcome, the results suggested that it is influenced by multiple factors that should be considered in the randomization process.
The early group had better range of motion and outcome scores at 6 weeks, which is not surprising given that the late group had just had the casts removed by that time. The early group had higher physical component SF-36 scores at 12 months but not at any other visits. These findings alone are not sufficient to justify changing treatment.
When interpreting the findings of Dehghan and colleagues, 2 points should be considered. First, the study compared early mobilization and early weight-bearing with late mobilization and late weight-bearing. The study did not include a group of patients who received early mobilization and late weight-bearing, which was the recommendation of the American Academy of Orthopaedic Surgeons Orthopaedic Knowledge Update1 almost 20 years ago and presumably is current practice for many orthopaedists. Second, the authors defined loss of reduction as >2 mm; however, posttraumatic osteoarthritis can occur with less displacement, and a follow-up limited to 1 year would likely be too short to detect such a condition.
Should this trial change practice? Yes. For nondiabetic adults with isolated unstable ankle fractures that do not involve the syndesmosis and do not require fixation of the posterior malleolus, surgeons should consider allowing weight-bearing in an orthosis at 2 weeks.
Disclosure: The author indicated that no external funding was received for any aspect of this work. The Disclosure of Potential Conflicts of Interest forms are provided with the online version of the article (http://links.lww.com/JBJS/A13).