Operative vs. Non-Operative Treatment of Acute Ruptures of the Achilles Tendon

Not Applicable

Terminated

• Conditions: Ruptured Achilles Tendon
• Interventions: Procedure: non-operative; Procedure: operative

• Registration Number: NCT01711307
• Lead Sponsor: Mark Glazebrook

Brief Summary

The proposed trial is a multi-centre prospective randomized controlled trial comparing outcomes of patients with acute Achilles tendon ruptures treated either non-operatively or with open operative tendon repair. All patients will undergo accelerated functional rehabilitation. The primary outcome measure is Achilles tendon re-rupture rate.

Detailed Description

Equivalent clinical outcomes to surgical repair; reduced morbidity and disability to subjects through elimination of a surgical repair; reduction of cost to patients by eliminating need for surgery.

Study Timeline

• Study Start: 2012-10-01
• Study First Submitted: 2012-10-11
• Study First Submitted QC: 2012-10-18
• Study First Posted: 2012-10-22
• Primary Completion: 2019-12-31
• Study Completion: 2020-06-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-07
• Last Update Posted: 2020-07-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Complete mid-substance rupture of the Achilles tendon as diagnosed on clinical exam
• Present for initial assessment and treatment with application of a plantar-flexed cast within 48 hours of their injury.
• Referred to one of the participating orthopaedics surgeons in a timely fashion so as to allow for further treatment (operative repair or initiation of the rehabilitation protocol) within 14 days of their injury.

Exclusion Criteria

• Open Achilles injury
• Achilles injury that is not a mid-substance tendon injury
• Any additional injury to the ipsilateral lower extremity
• Contraindication to surgery or anesthetic
• (Physical or mental) that may interfere with compliance with the rehabilitation protocol
• Any known factor for increased risk of Achilles tendon rupture (i.e. diabetes mellitus, immunosuppressive therapy including local or systemic steroids, and fluoroquinolone use).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non-operative	non-operative	cast applied within 48 hours
operative	operative	cast applied within 48 hours and surgery within 14 days

Primary Outcome Measures

Name	Time	Method
Operative vs non operative Treatment of acute ruptures of Achilles tendon.	1 year	The primary outcome measure is Achilles tendon re-rupture rate

Secondary Outcome Measures

Name	Time	Method
Operative vs. Non-Operative Treatment of Acute Ruptures of the Achilles Tendon	2 year	1. The Achilles tendon Total Rupture Score (ATRS)

Trial Locations

Locations (1)

Halifax Infirmary; 🇨🇦 Halifax, Nova Scotia, Canada