Operative Versus Non-Operative Treatment of Achilles Tendon Rupture - Full Text View

Operative Versus Non-Operative Treatment of Achilles Tendon Rupture

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	Fowler Kennedy Sport Medicine Clinic 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

U.S. FDA Resources

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.

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
Estimated Study Completion Date:	December 2007

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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

Study ID Numbers:	99-36
First Received:	January 31, 2006
Last Updated:	September 15, 2006
ClinicalTrials.gov Identifier:	NCT00284648
Health Authority:	Canada: Health Canada

Keywords provided by Fowler Kennedy Sport Medicine Clinic:

Achilles tendon

Rupture

Non-operative

Operative

Study placed in the following topic categories:

Wounds and Injuries

Disorders of Environmental Origin

Rupture

ClinicalTrials.gov processed this record on September 05, 2008