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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Capital District Health Authority, Canada
Sponsor:
Information provided by (Responsible Party):
Mark Glazebrook, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01711307
First received: October 11, 2012
Last updated: October 18, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Ruptured Achilles Tendon
Procedure: operative
Procedure: non-operative

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Operative vs non operative Treatment of acute ruptures of Achilles tendon. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The primary outcome measure is Achilles tendon re-rupture rate


Secondary Outcome Measures:
  • Operative vs. Non-Operative Treatment of Acute Ruptures of the Achilles Tendon [ Time Frame: 2 year ] [ Designated as safety issue: No ]
    1. The Achilles tendon Total Rupture Score (ATRS)


Estimated Enrollment: 220
Study Start Date: October 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01711307

Contacts
Contact: Patricia A Francis, RN 1902 473 5993 francisp@cdha.nshealth.ca

Locations
Canada, Nova Scotia
Halifax Infirmary Recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Contact: Patricia Francis, RN    902 473 5993    francisp@cdha.nshealth.ca   
Principal Investigator: Dr Mark Glazebrook, MD         
Sponsors and Collaborators
Capital District Health Authority, Canada
Investigators
Principal Investigator: Dr. Mark Glazebrook, MD Capital Health District Authority
  More Information

No publications provided

Responsible Party: Mark Glazebrook, Dr Mark Glazebrook, MSc,PHD, Dip Sports Med, MD FRCS(c), Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01711307     History of Changes
Other Study ID Numbers: Version1
Study First Received: October 11, 2012
Last Updated: October 18, 2012
Health Authority: Canada: Health Canada

Keywords provided by Capital District Health Authority, Canada:
Achilles

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on August 21, 2014