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Tendon Transfer

Flexor Hallucis Longus Tendon Transfer for Achilles Tendinopathy

Phase 4

Waitlist Available

Led By Gregory P Witkowski, MD

Research Sponsored by OAD Orthopaedics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male and female 18 years or older

immobilization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is comparing the long-term outcomes of two surgeries for Achilles tendon pain that comes from an extra bone growth.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include pain at the transfer site, infection, nerve damage around the operated area, difficulty moving toes or ankle post-surgery, and possible need for additional surgeries if complications occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am unable to move around freely.

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I've tried special shoe modifications for over 6 months without improvement.

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I have been diagnosed with Achilles tendinosis.

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My big toe tendon is not damaged.

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I have hardening at my heel and tight calf muscles.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Statistical difference

Trial Design

2Treatment groups

Active Control

Group I: FHL tendon transferredActive Control1 Intervention

Surgical group in which the FHL tendon was transferred

Group II: FHL tendon not transferredActive Control2 Interventions

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

OAD OrthopaedicsLead Sponsor

3 Previous Clinical Trials

81 Total Patients Enrolled

Gregory P Witkowski, MDPrincipal InvestigatorOAD Orthopaedics

Media Library

Flexor Hallucis Longus Tendon transfer (Tendon Transfer) Clinical Trial Eligibility Overview. Trial Name: NCT01341509 — Phase 4

Achilles Tendinopathy Research Study Groups: FHL tendon transferred, FHL tendon not transferred

Achilles Tendinopathy Clinical Trial 2023: Flexor Hallucis Longus Tendon transfer Highlights & Side Effects. Trial Name: NCT01341509 — Phase 4

Flexor Hallucis Longus Tendon transfer (Tendon Transfer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01341509 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for participants in this research endeavor?

"According to records on clinicaltrials.gov, the team is not currently recruiting for this experiment which was initially published in April 2011 and most recently updated in June 2013. Although no new participants are being sought at present, there are 74 other medical trials that remain open for enrollment."

Answered by AI