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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2015 by Mark Glazebrook, Nova Scotia Health Authority.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01711307
First Posted: October 22, 2012
Last Update Posted: August 11, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mark Glazebrook, Nova Scotia Health Authority
  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
Intervention Model: Parallel Assignment
Masking: None (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.

Resource links provided by NLM:


Further study details as provided by Mark Glazebrook, Nova Scotia Health Authority:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Operative vs. Non-Operative Treatment of Acute Ruptures of the Achilles Tendon [ Time Frame: 2 year ]
    1. The Achilles tendon Total Rupture Score (ATRS)


Estimated Enrollment: 220
Study Start Date: October 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Nova Scotia Health Authority
Investigators
Principal Investigator: Dr. Mark Glazebrook, MD Capital Health District Authority
  More Information

Responsible Party: Mark Glazebrook, Dr Mark Glazebrook, MSc,PHD, Dip Sports Med, MD FRCS(c), Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT01711307     History of Changes
Other Study ID Numbers: Version1
First Submitted: October 11, 2012
First Posted: October 22, 2012
Last Update Posted: August 11, 2015
Last Verified: August 2015

Keywords provided by Mark Glazebrook, Nova Scotia Health Authority:
Achilles
Rupture

Additional relevant MeSH terms:
Rupture
Wounds and Injuries