Operative Versus Non-operative Treatment of Achilles Tendon Rupture

This study has been completed.
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
Fowler Kennedy Sport Medicine Clinic
ClinicalTrials.gov Identifier:
NCT00284648
First received: January 31, 2006
Last updated: April 7, 2014
Last verified: January 2009
  Purpose

This study is intended to determine whether the optimal treatment of acute Achilles tendon ruptures is surgical repair or functional bracing.

Our hypotheses are surgical repair will: 1) Result in a clinically relevant decrease in re-rupture rate and 2) Result in a clinically relevant improvement in disease specific quality of life and 3) A clinically relevant improvement in functional outcome measures


Condition Intervention
Achilles Tendon Rupture
Procedure: Surgical repair Achilles tendon rupture
Procedure: Non-surgical repair Achilles tendon rupture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Operative Versus Non-operative Treatment of Achilles Tendon Rupture: A Multicentre, Prospective Randomized Study.

Further study details as provided by Fowler Kennedy Sport Medicine Clinic:

Primary Outcome Measures:
  • Re-rupture rate

Secondary Outcome Measures:
  • Minor complications
  • Major Complications
  • Range of Motion, Strength and Calf Circumference
  • Strength Testing
  • Disease Specific Quality of Life

Estimated Enrollment: 150
Study Start Date: December 2000
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Complete Achilles Tendon Rupture Less than 7 days from date of injury Age 18-70 years of age Ability to follow rehab protocol

Exclusion Criteria:

Inability to Speak English Significant ipsilateral injury Open injury to Achilles tendon Neurological disease (ie stroke, cerebral palsy) Collagen Disease (ie Ehlers Danlos disease) Pregnancy Fluoroquinolone associated rupture (rupture within 2 weeks of taking medication) Unfit for surgery Diabetes Peripheral Vascular disease Avulsion of Achilles tendon from calcaneus

  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: NCT00284648

Locations
Canada, Ontario
Fowler Kennedy Sport Medicine Clinic, University of Western Ontario
London, Ontario, Canada, N6A 3K7
Sponsors and Collaborators
Fowler Kennedy Sport Medicine Clinic
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Kevin Willits, MD University of Western Ontario, Canada
  More Information

Publications:
Responsible Party: Kevin Willits, FKSMC
ClinicalTrials.gov Identifier: NCT00284648     History of Changes
Other Study ID Numbers: 99-36
Study First Received: January 31, 2006
Last Updated: April 7, 2014
Health Authority: Canada: Health Canada

Keywords provided by Fowler Kennedy Sport Medicine Clinic:
Achilles tendon
Rupture
Non-operative
Operative

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on July 20, 2014