A clinical trial comparing the effectiveness of a plaster cast to a functional brace in the treatment of adults with ankle fractures

Phase 3

Completed

• Conditions: Ankle fracture; Injury, Occupational Diseases, Poisoning; Injuries and Accidents/ Injuries to the ankle and foot

• Registration Number: ISRCTN15537280
• Lead Sponsor: niversity of Warwick

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30567826 protocol (added 04/11/2019) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34226192/ (added 07/07/2021) 2021 Results article in https://doi.org/10.1136/bmj.n1506 (added 30/07/2021) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/32024789/ Qualitative pre-results (added 06/09/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-24
• Study Completion: 2021-12-31
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 671

Inclusion Criteria

1. Provision of written informed consent
2. Aged 18 years or over
3. A closed ankle fracture for which the treating clinician would consider plaster cast a reasonable management option
4. Within 3 weeks of operative treatment or injury if non-operatively managed

Exclusion Criteria

1. Ankle fracture secondary to known metastatic disease
2. Complex intra-articular fracture (e.g. Pilon fracture)
3. In the opinion of the surgeon the patient would require manipulation and close contact casting
4. In the opinion of the surgeon the patient would require manipulation and moulded cast
5. Wound complications following surgical management contraindicating Functional brace intervention
6. Previous ankle fracture randomised in the present trial
7. Evidence that the patient would be unable to adhere to trial procedures or complete postal questionnaires
8. Known pre-existing neuropathic joint disease contraindicating functional brace intervention

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptom evaluation is measured using Olerud Molander Ankle Score questionnaire (this will be collected using patient questionnaires sent via post) at 4 months

Secondary Outcome Measures

Name	Time	Method
1. Symptom evaluation is measured using Olerud Molander Ankle Score questionnaire at six weeks, 10 weeks, six months and 24 months<br>2. Surgical outcomes are measured using the Manchester-Oxford Foot and Ankle Questionnaire at four months<br>3. Health status is measured using EuroQol five dimensions questionnaire (EQ-5D) at 6 weeks, 10 weeks, 16 weeks, 24 weeks, 12 months, 18 months and 24 months.<br>4. Disability is measured using the disability rating index at 6 weeks, 10 weeks, 16 weeks, 24 weeks, 12 months, 18 months and 24 months<br>5. Cost is measured using a patient reported questionnaire at 6 weeks, 10 weeks, 16 weeks, 24 weeks, 12 months, 18 months and 24 months<br>6. Complication rate is measured using a patient reported questionnaire at 6 weeks, 10 weeks, 16 weeks, 24 weeks, 12 months, 18 months and 24 months