Standard Non Operative Treatment Versus Accelerated Rehabilitation of Achilles Tendon Ruptures

NCT02598843 | Completed DMC

• 1 other identifier: IRAS ID 89061
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to directly compare traditional plaster treatment with early weightbearing in a walking boot for the non operative treatment of acute achilles tendon rupture.

Conditions

Rupture of Achilles Tendon

Outcome Measures

Primary Outcomes (1)

• SMFA (Short Musculoskeletal Function Assessment Questionnaire)

  46 question score. Patients are asked to tick boxes labelled between 1 (indicating good function/no problems) and 5 (poor function/significant problems) for each question and the responses are used to calculate a "dysfunction index", a "bother index" and an "overall SMFA score". These will be reported for each group with measure of central tendency (mean/median) and standard deviations/interquartile range.

  final followup/one year

Secondary Outcomes (17)

• SMFA (Short Musculoskeletal Function Assessment Questionnaire)

  At the initial review, upon enrolment in the study, patients are asked to complete the questionnaire detailing their immediate pre-injury status (ie status one day before injury). Then reassessed at 26 weeks.

• Incidence of thromboembolic events

  1 year

• Ankle and subtalar motion

  10, 26 and 52 weeks

• Calf circumference

  10, 26 and 52 weeks

• Visual Analogue Score (VAS) for pain

  Initial review, 4,8,10,26,52 weeks.

Study Arms (2)

Standard treatment protocol

ACTIVE COMPARATOR

Cast immobilisation with 4 weeks in equinus cast (non-weight bearing) followed by 4 weeks in semi-equinus cast (non-weightbearing) and 2 weeks in neutral cast (full weightbearing). At this point, the cast is removed and patients mobilise fully weightbearing for a further 2 weeks out of cast, with internal shoe insert heel raise. Commence physiotherapy at 10 weeks, when cast removed.

Other: Standard treatment protocol

Accelerated rehabilitation

EXPERIMENTAL

4 weeks in Ossur rebound walking boot with 2 heel wedges (3cm), 2 weeks in Ossur rebound walking boot with 1 heel wedge (1.5cm) and 2 weeks in Ossur rebound walking boot with no heel wedges (neutral position). Fully weightbearing throughout. Commence physiotherapy at 8 weeks.

Other: Accelerated Rehabilitation

Interventions

Standard treatment protocol OTHER

Cast Protocol 4 weeks in Full Equinus cast - Non Weight Bearing (NWB) with axillary crutches; 4 weeks in Semi-Equinus cast NWB with axillary crutches; 2 weeks in neutral cast - Full Weight Bearing (FWB); 2 weeks FWB out of cast, with shoe insert heel raise. Followed by course of physiotherapy

Standard treatment protocol

Accelerated Rehabilitation OTHER

4 weeks in Ossur Rebound walking boot with 3cm heel raise, worn continuously including in bed. Weight bearing as tolerated (WBAT)/FWB - crutches for balance; 2 weeks in Rebound walking boot with 1.5cm heel raise (WBAT/FWB - crutches for balance; 2 weeks in Rebound walking boot with foot in neutral. At 8 weeks, remove boot and allow FWB out of boot. At 8 weeks after initiation of treatment, physiotherapy is commenced.

Accelerated rehabilitation

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients aged 16-60 years old with an acute rupture of the Achilles tendon

You may not qualify if:

• Patients who do not have an acute rupture (ie. delayed presentation \>2 weeks)
• Patients who present with a re-rupture of a previously treated Achilles tendon
• Patients from outside the Lothian (local treatment) area who are unwilling to attend follow-up at the study institution.
• Latex allergy.

Sponsors & Collaborators

• NHS Lothian: lead

Study Sites (1)

Royal Infirmary Edinburgh

Edinburgh, Lothian, EH16 4SA, United Kingdom

Location

Related Publications (1)

• Maempel JF, Clement ND, Duckworth AD, Keenan OJF, White TO, Biant LC. A Randomized Controlled Trial Comparing Traditional Plaster Cast Rehabilitation With Functional Walking Boot Rehabilitation for Acute Achilles Tendon Ruptures. Am J Sports Med. 2020 Sep;48(11):2755-2764. doi: 10.1177/0363546520944905. Epub 2020 Aug 20.

  PMID: 32816521 DERIVED

Study Officials

• Leela Biant, BSc (Hons) MBBS FRSCEd MSres

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: November 6, 2015
• Study Start: November 1, 2013
• Primary Completion: July 3, 2019
• Study Completion: July 3, 2019
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

GB (1)