Keene, David J., Lamb, S. E. (Sallie E.), Mistry, Dipesh, Tutton, Elizabeth, Lall, Ranjit, Handley, Robert and Willett, Keith (2018) Three-year follow-up of a trial of close contact casting vs surgery for initial treatment of unstable ankle fractures in older adults. JAMA: The Journal of the American Medical Association, 319 (12). pp. 1274-1276. doi:10.1001/jama.2018.0811 ISSN 0098-7484.

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Abstract

A randomized clinical trial of close contact casting vs the usual practice of surgery for treating unstable ankle fractures in older adults found equivalent ankle function outcomes at 6 months.1 Higher rates of radiological ankle malunion in the casting vs surgical groups (15% vs 3%, respectively) and nonunion (medial malleolus: 7% vs 1%, respectively) suggested that equivalence between the 2 groups may be lost if symptoms or functional limitations from posttraumatic arthritis manifest later.2 A follow-up at least 3 years after randomization was conducted to determine if equivalence persisted over time.

Methods:
This study was a prespecified extended follow-up of a pragmatic, multicenter, equivalence randomized clinical trial.1 The National Research Ethics Service, Oxfordshire, gave approval; written informed consent was obtained. Participants were adults older than 60 years with acute unstable malleolar fracture(s) from 24 UK centers. Participants had received surgery (usual local practice internal fixation) or close contact casting, in which a minimally padded cast was applied after closed fracture reduction by an orthopedic surgeon in an operating room under anesthesia. Data were collected for at least 3 years after randomization using patient-reported postal questionnaires.

The primary outcome measure for the original trial was the Olerud and Molander Ankle Score (OMAS; range, 0-100, higher scores = better ankle function) at 6 months,3 with a prespecified equivalence margin of ±6 points. Extended follow-up used the same primary outcome and equivalence margin and assessed quality of life and pain as secondary outcomes (Table 1). A post hoc analysis of additional operations after 6 months was also conducted. Per-protocol primary analysis was used, consistent with the main trial.1 Random-effects models estimated mean differences and 95% CIs between treatments adjusted for age, sex, fracture pattern, baseline score, and time to follow-up, including the center variable as a random effect. The random-effects model was also used post hoc to assess differences in OMAS for participants with vs without radiological malunion and nonunion at 6 months. Change from baseline score was analyzed for outcomes without normal distribution. The primary outcome at extended follow-up assessed equivalence with the null hypothesis that the 2 groups were not equivalent. For all other outcomes, tests were 2-sided with a P value of .05 or less for significance. Analyses were conducted with Stata (StataCorp), version 15.0.

Results:
From September 2013 through November 2016, 450 of the 620 randomized participants (73%) responded to follow-up at a median of 3 years (range, 2.9-9.5). Responders and nonresponders had similar characteristics (Table 1). Most responders lived in their own home (209 of 222 participants [94%] in the surgery group and 196 of 206 participants [95%] in the casting group).

Surgery and casting participants had equivalent ankle function (mean OMAS: 79.4 in the surgery group vs 76.3 in the casting group; difference, −1.3 [95% CI, −5.6 to 3.0]) and no significant differences in quality of life or pain (Table 2). Twenty-two of 222 surgery participants (10%) and 17 of 206 casting participants (8%) had operations after 6 months, including surgical implant removals (15 in the surgery group [7%] vs 8 in the casting group [4%]), arthrodesis (1 in the surgery group [0.5%] vs 3 in the casting group [1.5%]), arthroplasty (1 in the surgery group [0.5%] and 1 in the casting group [0.5%]), and infection-related procedures (2 in the surgery group [1%] and 0 in the casting group). Five casting participants (2%) had internal fixations for nonunion after 6 months. There was 1 internal fixation revision, 1 arthroscopy, and 1 hindfoot osteotomy among surgery participants. In post hoc analysis, from randomization to extended follow-up, mean total operating room procedures per participant (per protocol) were 1.2 (SD, 0.5) in the surgery group and 1.3 (SD, 0.6) in the casting group, and mean total surgical procedures per participant were 1.2 (SD, 0.5) in the surgery group and 0.3 (SD, 0.6) in the casting group.

Of 67 participants with radiological abnormalities at 6 months, 43 (64%) provided extended follow-up data. Those with malleolar malunion at 6 months had significantly lower OMAS scores (n = 30; mean, 58.7 [SD, 33.1]) than those without (n = 372; mean, 79.8 [SD, 23.5]; mean difference, −16.4 [95% CI, −25.0 to −7.8]; P < .001). Participants with medial malleolar nonunion at 6 months also had significantly lower OMAS scores (n = 13; mean, 55.4 [SD, 38.5]) than those without (n = 388; mean, 79.1 [SD, 23.9]; mean difference, −13.9 [95% CI, −26.6 to −1.2]; P = .03). Treatment was not a significant covariate in these analyses.

Discussion:
Equivalence in function between casting and immediate surgery strategies was maintained at 3 years. In post hoc analyses, participants with radiological malunion and medial malleolar nonunion at 6 months had lower OMAS scores at 3-year follow-up. These longer-term outcomes will support surgeon and patient decision making. The findings indicate that treatment of ankle fractures in older adults should focus on obtaining and maintaining a reduction until union, by the most conservative means possible.

The study was limited by its reliance on self-reported events requiring participant recall and by loss to follow-up. However, there were sufficient data to estimate and conclude equivalence in the primary outcome.

Item Type:	Journal Article
Subjects:	R Medicine > RD Surgery
Divisions:	Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Warwick Research in Nursing
Library of Congress Subject Headings (LCSH):	Ankle -- Fractures -- Treatment -- Evaluation, Fractures in old age -- Treatment -- Evaluation, Ankle -- Surgery -- Evaluation, Clinical trials
Journal or Publication Title:	JAMA: The Journal of the American Medical Association
Publisher:	American Medical Association
ISSN:	0098-7484
Official Date:	March 2018
Dates:	Date Event March 2018 Published 23 January 2018 Accepted
Volume:	319
Number:	12
Page Range:	pp. 1274-1276
DOI:	10.1001/jama.2018.0811
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access (Creative Commons)
Date of first compliant deposit:	11 April 2018
Date of first compliant Open Access:	27 September 2018
RIOXX Funder/Project Grant:	Project/Grant ID RIOXX Funder Name Funder ID 07/37/61 Health Technology Assessment programme http://dx.doi.org/10.13039/501100000664 UNSPECIFIED National Institute for Health Research http://dx.doi.org/10.13039/501100000272 PDF-2016-09-056 National Institute for Health Research http://dx.doi.org/10.13039/501100000272

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