A Randomized Trial to Evaluate the Effectiveness of Transferring the Flexor Hallucis Longus Tendon

June 10, 2013 updated by: OAD Orthopaedics

Insertional Achilles Tendinopathy: A Randomized Trial to Evaluate the Effectiveness of Transferring the Flexor Hallucis Longus Tendon

The optimal surgical treatment for insertional Achilles tendinopathy remains unclear. The purpose of this study is to evaluate the long-term outcome of surgical treatment by comparing the patient reported outcomes of Insertional Achilles Tendinopathy; Achilles tendon debridement, excision calcaneal exostosis, Strayer procedure, secondary repair of Achilles with flexor hallucis longus (FHL) transfer and Achilles tendon debridement, excision calcaneal exostosis, Strayer procedure, secondary repair of Achilles without FHL transfer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Warrenville, Illinois, United States, 60555
        • Recruiting
        • OAD Orthopaedics
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gregory P Witkowski, MD
        • Sub-Investigator:
          • Jeffrey A Senall, md

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female 18 years or older
  • Diagnosed with insertional Achilles tendinosis by history and physical exam
  • Confirmed by x-ray and MRI
  • Calcification at the Achilles insertion and gastrocnemius tightness.

  • Failure of the following non-operative treatment for greater than 6 months: *shoe modifications

    • physical therapy
    • immobilization
    • and home exercise program.
  • In addition, participant must have an intact flexor hallucis longus tendon.

Exclusion Criteria:

  • Patients who have failed surgery for the same and patients with diabetic neuropathy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: FHL tendon transferred
Surgical group in which the FHL tendon was transferred
Procedure: Transfer of the Flexor Hallucis Longus Tendon
The Flexor Hallucis Longus Tendon was transferred during surgery for insertional achilles tendinopathy
Active Comparator: FHL tendon not transferred
Procedure: Flexor Hallucis Longus Tendon transfer
The flexor hallucis longus tendon was transferred during surgery for insertional achilles tendinopathy
Procedure: No transfer of Flexor Hallucis Longus tendon
There was no transfer of the Flexor Hallucis Longus tendon in surgery for insertional achilles tendinopathy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Statistical difference
Time Frame: 2 years
To detect a 20% difference in clinical outcomes between the two surgical groups.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OAD Orthopaedics

Investigators

  • Principal Investigator: Gregory P Witkowski, MD, OAD Orthopaedics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Anticipated)

April 1, 2014

Study Registration Dates

First Submitted

April 22, 2011

First Submitted That Met QC Criteria

April 22, 2011

First Posted (Estimate)

April 25, 2011

Study Record Updates

Last Update Posted (Estimate)

June 11, 2013

Last Update Submitted That Met QC Criteria

June 10, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GW100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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