Flexor Hallucis Longus Tendon Transfer for Achilles Tendinopathy

Recruiting in Palo Alto (17 mi)

Overseen by Gregory P Witkowski, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: OAD Orthopaedics

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Gregory P Witkowski, MD

Principal Investigator

OAD Orthopaedics

Eligibility Criteria

This trial is for adults over 18 with insertional Achilles tendinopathy confirmed by x-ray and MRI, who haven't improved after 6+ months of non-surgical treatments like shoe changes, physical therapy, and exercises. They must have a healthy flexor hallucis longus tendon but can't join if they've had failed surgery for this condition or suffer from diabetic neuropathy.

Inclusion Criteria

I am 18 years old or older.

This is not a criterion, but a type of medical treatment that involves exercises and techniques to improve physical function and mobility.

I am unable to move around freely.

Exclusion Criteria

I have had unsuccessful surgery or have diabetic neuropathy.

Treatment Details

Interventions

• Flexor Hallucis Longus Tendon transfer (Tendon Transfer)
• No transfer of Flexor Hallucis Longus tendon (Procedure)

Trial Overview The study compares two surgical methods to treat Achilles tendinopathy: one includes transferring the flexor hallucis longus tendon during surgery; the other does not. The goal is to see which method gives better patient-reported outcomes in the long term.

Participant Groups

Group I: FHL tendon transferred Active Control 1 Intervention

Surgical group in which the FHL tendon was transferred

Group II: FHL tendon not transferred Active Control 2 Interventions

Who Is Running the Clinical Trial?

OAD Orthopaedics

Lead Sponsor

Trials

4

Recruited

100+