NCT02598843

Standard Non Operative Treatment Versus Accelerated Rehabilitation of Achilles Tendon Ruptures

Functional Outcomes After Conservative Management of the Acutely Ruptured Achilles Tendon in the Under 60 Age Group. A Randomised Controlled Trial Comparing Standard Conservative Management With Accelerated Rehabilitation Using a Moon Boot

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: NHS Lothian · Other Government
• Sex: All
• Age: 16 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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
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.

Timeline

• Start date: 2013-11-01
• Primary completion: 2019-07-03
• Completion: 2019-07-03
• First posted: 2015-11-06
• Last updated: 2020-01-27

Locations

1 site across 1 country: United Kingdom