ClinicalTrials.gov
ClinicalTrials.gov Menu

Operative Versus Non-operative Treatment of Achilles Tendon Rupture

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.
ClinicalTrials.gov Identifier: NCT00284648
Recruitment Status : Completed
First Posted : February 1, 2006
Last Update Posted : November 30, 2015
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Sharon Griffin, Fowler Kennedy Sport Medicine Clinic

Brief Summary:

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 or disease Intervention/treatment Phase
Achilles Tendon Rupture Procedure: Surgical repair Achilles tendon rupture Procedure: Non-surgical repair Achilles tendon rupture Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Operative Versus Non-operative Treatment of Achilles Tendon Rupture: A Multicentre, Prospective Randomized Study.
Study Start Date : December 2000
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears




Primary Outcome Measures :
  1. Re-rupture rate

Secondary Outcome Measures :
  1. Minor complications
  2. Major Complications
  3. Range of Motion, Strength and Calf Circumference
  4. Strength Testing
  5. Disease Specific Quality of Life


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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


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): 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

Publications:
Responsible Party: Sharon Griffin, Research Coordinator, Fowler Kennedy Sport Medicine Clinic
ClinicalTrials.gov Identifier: NCT00284648     History of Changes
Other Study ID Numbers: 99-36
First Posted: February 1, 2006    Key Record Dates
Last Update Posted: November 30, 2015
Last Verified: November 2015

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

Additional relevant MeSH terms:
Rupture
Wounds and Injuries