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

July 7, 2020 updated by: Mark Glazebrook

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Halifax Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: non-operative
cast applied within 48 hours
Procedure: non-operative
casting within 48 hrs
Active Comparator: operative
cast applied within 48 hours and surgery within 14 days
Procedure: operative

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative vs non operative Treatment of acute ruptures of Achilles tendon.
Time Frame: 1 year
The primary outcome measure is Achilles tendon re-rupture rate
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative vs. Non-Operative Treatment of Acute Ruptures of the Achilles Tendon
Time Frame: 2 year
1. The Achilles tendon Total Rupture Score (ATRS)
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mark Glazebrook

Collaborators

Nova Scotia Health Authority

Investigators

  • Principal Investigator: Dr. Mark Glazebrook, MD, Capital Health District Authority

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2012

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

October 11, 2012

First Submitted That Met QC Criteria

October 18, 2012

First Posted (Estimate)

October 22, 2012

Study Record Updates

Last Update Posted (Actual)

July 9, 2020

Last Update Submitted That Met QC Criteria

July 7, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Version1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

COA AAOS AOFAS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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