Operative Versus Non-Operative Treatment of Achilles Tendon Rupture

This study has been completed.

First Received: January 31, 2006 Last Updated: January 28, 2009 History of Changes

Sponsor:	Fowler Kennedy Sport Medicine Clinic
Collaborator:	The Physicians' Services Incorporated Foundation
Information provided by:	Fowler Kennedy Sport Medicine Clinic
ClinicalTrials.gov Identifier:	NCT00284648

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:	Treatment, Randomized, Single Blind, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Operative Versus Non-Operative Treatment of Achilles Tendon Rupture: A Multicentre, Prospective Randomized Study.

Resource links provided by NLM:

MedlinePlus related topics: Surgery

U.S. FDA Resources

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

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

No publications provided

Responsible Party:	FKSMC ( Kevin Willits )
Study ID Numbers:	99-36
Study First Received:	January 31, 2006
Last Updated:	January 28, 2009
ClinicalTrials.gov Identifier:	NCT00284648 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Fowler Kennedy Sport Medicine Clinic:

Achilles tendon
Rupture
Non-operative
Operative

Additional relevant MeSH terms:

Wounds and Injuries
Disorders of Environmental Origin
Rupture

ClinicalTrials.gov processed this record on November 27, 2009