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Trial record 1 of 28 for:    Open Studies | "Achilles Tendon"
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Operative vs. Non-Operative Treatment of Acute Ruptures of the Achilles Tendon (AchillesRCT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Mark Glazebrook, Nova Scotia Health Authority
Information provided by (Responsible Party):
Mark Glazebrook, Nova Scotia Health Authority Identifier:
First received: October 11, 2012
Last updated: August 10, 2015
Last verified: August 2015
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: 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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01711307

Contact: Patricia A Francis, RN 1902 473 5993

Canada, Nova Scotia
Halifax Infirmary Recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Contact: Patricia Francis, RN    902 473 5993   
Principal Investigator: Dr Mark Glazebrook, MD         
Sponsors and Collaborators
Nova Scotia Health Authority
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 Identifier: NCT01711307     History of Changes
Other Study ID Numbers: Version1
Study First Received: October 11, 2012
Last Updated: August 10, 2015

Keywords provided by Mark Glazebrook, Nova Scotia Health Authority:

Additional relevant MeSH terms:
Wounds and Injuries processed this record on May 25, 2017