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

Ruptured Achilles Tendon Clinical Trial

— AchillesRCT  

Official title:

Operative vs. Non-Operative Treatment of Acute Ruptures of the Achilles Tendon: A Multi-centered Randomized Control Trial Using Standardized Objective and Subjective Outcome Measurement to Determine Rerupture Rate.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01711307
• Other study ID #: Version1
• Status: Terminated
• Phase: N/A
• Start date: October 1, 2012
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2020
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 220
• Est. completion date: June 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Rupture
• Ruptured Achilles Tendon

Intervention

Procedure:
• operative

• non-operative
casting within 48 hrs

Locations

Country	Name	City	State
Canada	Halifax Infirmary	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
Mark Glazebrook	Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative vs non operative Treatment of acute ruptures of Achilles tendon.	The primary outcome measure is Achilles tendon re-rupture rate	1 year
Secondary	Operative vs. Non-Operative Treatment of Acute Ruptures of the Achilles Tendon	1. The Achilles tendon Total Rupture Score (ATRS)	2 year