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

Study Overview
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Brief Summary
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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.

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

Conditions
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Achilles Tendinopathy

Intervention / Treatment
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* Procedure: Flexor Hallucis Longus Tendon transfer
* Procedure: Transfer of the Flexor Hallucis Longus Tendon
* Procedure: No transfer of Flexor Hallucis Longus tendon


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical Treatment of Insertional Achilles Tendinopathy