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JAMA. 2016 Oct 11;316(14):1455-1463. doi: 10.1001/jama.2016.14719.

Close Contact Casting vs Surgery for Initial Treatment of Unstable Ankle Fractures in Older Adults: A Randomized Clinical Trial.

Author information

1
Kadoorie Centre for Critical Care Research and Education, John Radcliffe Hospital, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom.
2
Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, United Kingdom.
3
Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom4Now with Hoffmann-La Roche, Mississauga, Ontario, Canada.
4
Kadoorie Centre for Critical Care Research and Education, John Radcliffe Hospital, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom5Royal College of Nursing Research Institute, University of Warwick, Coventry, United Kingdom.
5
Oxford Trauma Service, John Radcliffe Hospital, Oxford University Hospitals NHS Trust, Oxford, United Kingdom.
6
Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.
7
Department of Orthopaedic Surgery, Southmead Hospital, North Bristol NHS Trust, Bristol, United Kingdom.
8
Department of Orthopaedic Surgery, Morriston Hospital, Abertawe Bro Morgannwg University Health Board, Swansea, United Kingdom.
9
Kadoorie Centre for Critical Care Research and Education, John Radcliffe Hospital, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom2Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, United Kingdom.

Abstract

Importance:

Ankle fractures cause substantial morbidity in older persons. Surgical fixation is the contemporary intervention but is associated with infection and other healing complications.

Objective:

To determine whether initial fracture treatment with close contact casting, a molded below-knee cast with minimal padding, offers outcome equivalent to that with immediate surgery, with fewer complications and less health resource use.

Design, Setting, and Participants:

This was a pragmatic, equivalence, randomized clinical trial with blinded outcome assessors. A pilot study commenced in May 2004, followed by multicenter recruitment from July 2010 to November 2013; follow-up was completed May 2014. Recruitment was from 24 UK major trauma centers and general hospitals. Participants were 620 adults older than 60 years with acute, overtly unstable ankle fracture. Exclusions were serious limb or concomitant disease or substantial cognitive impairment.

Interventions:

Participants were randomly assigned to surgery (n = 309) or casting (n = 311). Casts were applied in the operating room under general or spinal anesthesia by a trained surgeon.

Main Outcomes and Measures:

The primary 6-month, per-protocol outcome was the Olerud-Molander Ankle Score at 6 months (OMAS; range, 0-100; higher scores indicate better outcomes and fewer symptoms), equivalence prespecified as ±6 points. Secondary outcomes were quality of life, pain, ankle motion, mobility, complications, health resource use, and patient satisfaction.

Results:

Among 620 adults (mean age, 71 years; 460 [74%] women) who were randomized, 593 (96%) completed the study. Nearly all participants (579/620; 93%) received allocated treatment; 52 of 275 (19%) who initially received casting later converted to surgery, which was allowable in the casting treatment pathway to manage early loss of fracture reduction. At 6 months, casting resulted in ankle function equivalent to that with surgery (OMAS score, 66.0 [95% CI, 63.6-68.5] for surgery vs 64.5 [95% CI, 61.8-67.2] for casting; mean difference, -0.6 [95% CI, -3.9 to 2.6]; P for equivalence = .001). Infection and wound breakdown were more common with surgery (29/298 [10%] vs 4/275 [1%]; odds ratio [OR], 7.3 [95% CI, 2.6-20.2]), as were additional operating room procedures (18/298 [6%] for surgery and 3/275 [1%] for casting; OR, 5.8 [95% CI, 1.8-18.7]). Radiologic malunion was more common in the casting group (38/249 [15%] vs 8/274 [3%] for surgery; OR, 6.0 [95% CI, 2.8-12.9]). Casting required less operating room time compared with surgery (mean difference [minutes/participant], -54 [95% CI, -58 to -50]). There were no significant differences in other secondary outcomes: quality of life, pain, ankle motion, mobility, and patient satisfaction.

Conclusions and Relevance:

Among older adults with unstable ankle fracture, the use of close contact casting compared with surgery resulted in similar functional outcomes at 6 months. Close contact casting may be an appropriate treatment for such patients.

Trial Registration:

isrctn.com Identifier: ISRCTN04180738.

PMID:
27727383
DOI:
10.1001/jama.2016.14719
[Indexed for MEDLINE]

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