Standard Non Operative Treatment Versus Accelerated Rehabilitation of Achilles Tendon Ruptures

NHS Lothian

Status: Completed

Conditions: Rupture of Achilles Tendon

Treatments: Other: Accelerated Rehabilitation; Other: Standard treatment protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT02598843

IRAS ID 89061

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Standard treatment protocol

Active Comparator group

Description:

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.

Treatment:

Other: Standard treatment protocol

Accelerated rehabilitation

Experimental group

Description:

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.

Treatment:

Other: Accelerated Rehabilitation