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NCT01341509 Clinical Trial

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

Achilles Tendinopathy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01341509
Other study ID # GW100
Secondary ID
Status Recruiting
Phase Phase 4
First received April 22, 2011
Last updated June 10, 2013
Start date April 2011

Study information
Verified date June 2013
Source OAD Orthopaedics
Contact Marjorie L Delaney, APN
Phone 630-225-2554
Email marjorie.delaney@oadortho.com
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date
Est. primary completion date April 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Flexor Hallucis Longus Tendon transfer
The flexor hallucis longus tendon was transferred during surgery for insertional achilles tendinopathy
• Transfer of the Flexor Hallucis Longus Tendon
The Flexor Hallucis Longus Tendon was transferred during surgery for insertional achilles tendinopathy
• No transfer of Flexor Hallucis Longus tendon
There was no transfer of the Flexor Hallucis Longus tendon in surgery for insertional achilles tendinopathy

Locations
Country Name City State
United States OAD Orthopaedics Warrenville Illinois

Sponsors (1)
Lead Sponsor Collaborator
OAD Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Statistical difference To detect a 20% difference in clinical outcomes between the two surgical groups. 2 years No
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