Standard Non Operative Treatment Versus Accelerated Rehabilitation of Achilles Tendon Ruptures

NCT ID: NCT02598843

Last Updated: 2020-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2019-07-03

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.

Detailed Description

This injury has traditionally been treated in a plaster cast applied to the leg for a period of 10 weeks which allows the tendon to heal, or by an operation to repair the tendon. Research undertaken in the investigators department has shown that patients treated with surgery or with a plaster had similar chance of re-rupture of the tendon after treatment and gain a similar recovery. The investigators therefore now manage these injuries in a plaster.

More recently, further research has shown that a new type of non-surgical rehabilitation programme, which is quicker than the traditional non-surgical programme, gave a tendon re-rupture rate that was similar to that after surgical treatment. This new rehabilitation programme uses a walking boot fitted with a heel-raise (instead of the traditional plaster). The potential benefit of this quicker rehabilitation programme is that it allows the patient to put weight through the leg immediately, whereas patients treated with the traditional plaster cast non-surgical treatment cannot weight bear (this means that they are kept non-weightbearing and therefore have to use crutches) for the first 8 weeks. The time spent in the walking boot in this new, quicker rehabilitation programme is 8 weeks while that spent in plaster is 10 weeks. This new non-surgical, quicker rehabilitation programme is referred to as the accelerated non-surgical programme hereafter. There are no known increased risks with the accelerated rehabilitation programme.

Conditions

Rupture of Achilles Tendon

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard treatment protocol

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.

Group Type: ACTIVE_COMPARATOR

Standard treatment protocol

Intervention Type: 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

Accelerated rehabilitation

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.

Group Type: EXPERIMENTAL

Accelerated Rehabilitation

Intervention Type: 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.

Interventions

Standard treatment protocol

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

Intervention Type: OTHER

Accelerated Rehabilitation

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NHS Lothian

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leela Biant, BSc (Hons) MBBS FRSCEd MSres

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Locations

Royal Infirmary Edinburgh

Edinburgh, Lothian, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 32816521 (View on PubMed)

Other Identifiers

IRAS ID 89061

Identifier Type: -

Identifier Source: org_study_id