NCT00284648

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2000

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

November 30, 2015

Status Verified

November 1, 2015

Enrollment Period

6.6 years

First QC Date

January 31, 2006

Last Update Submit

November 26, 2015

Conditions

Achilles Tendon Rupture

Keywords

Achilles tendonRuptureNon-operativeOperative

Outcome Measures

Primary Outcomes (1)

  • Re-rupture rate

Secondary Outcomes (5)

  • Minor complications

  • Major Complications

  • Range of Motion, Strength and Calf Circumference

  • Strength Testing

  • Disease Specific Quality of Life

Interventions

Surgical repair Achilles tendon rupturePROCEDURE
Non-surgical repair Achilles tendon rupturePROCEDURE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fowler Kennedy Sport Medicine Clinic, University of Western Ontario

London, Ontario, N6A 3K7, Canada

Location

Related Publications (1)

  • Willits K, Amendola A, Bryant D, Mohtadi NG, Giffin JR, Fowler P, Kean CO, Kirkley A. Operative versus nonoperative treatment of acute Achilles tendon ruptures: a multicenter randomized trial using accelerated functional rehabilitation. J Bone Joint Surg Am. 2010 Dec 1;92(17):2767-75. doi: 10.2106/JBJS.I.01401. Epub 2010 Oct 29.

    PMID: 21037028BACKGROUND

MeSH Terms

Conditions

Rupture

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Kevin Willits, MD

    The University of Western Ontario

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Coordinator

Study Record Dates

First Submitted

January 31, 2006

First Posted

February 1, 2006

Study Start

December 1, 2000

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

November 30, 2015

Record last verified: 2015-11

Locations

CA(1)