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

NCT ID: NCT01341509

Last Updated: 2013-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

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.

Detailed Description

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Conditions

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Achilles Tendinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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FHL tendon transferred

Surgical group in which the FHL tendon was transferred

Group Type ACTIVE_COMPARATOR

Transfer of the Flexor Hallucis Longus Tendon

Intervention Type PROCEDURE

The Flexor Hallucis Longus Tendon was transferred during surgery for insertional achilles tendinopathy

FHL tendon not transferred

Group Type ACTIVE_COMPARATOR

Flexor Hallucis Longus Tendon transfer

Intervention Type PROCEDURE

The flexor hallucis longus tendon was transferred during surgery for insertional achilles tendinopathy

No transfer of Flexor Hallucis Longus tendon

Intervention Type PROCEDURE

There was no transfer of the Flexor Hallucis Longus tendon in surgery for insertional achilles tendinopathy

Interventions

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Flexor Hallucis Longus Tendon transfer

The flexor hallucis longus tendon was transferred during surgery for insertional achilles tendinopathy

Intervention Type PROCEDURE

Transfer of the Flexor Hallucis Longus Tendon

The Flexor Hallucis Longus Tendon was transferred during surgery for insertional achilles tendinopathy

Intervention Type PROCEDURE

No transfer of Flexor Hallucis Longus tendon

There was no transfer of the Flexor Hallucis Longus tendon in surgery for insertional achilles tendinopathy

Intervention Type PROCEDURE

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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OAD Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gregory P Witkowski, MD

Role: PRINCIPAL_INVESTIGATOR

OAD Orthopaedics

Locations

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OAD Orthopaedics

Warrenville, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Marjorie L Delaney, APN

Role: CONTACT

630-225-2554

Gregory P Witkowski, MD

Role: CONTACT

630-225-2663

Facility Contacts

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Marjorie L Delaney, APN

Role: primary

630-225-2554

Gregory P Witkowski, MD

Role: backup

630-225-2663

Other Identifiers

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GW100

Identifier Type: -

Identifier Source: org_study_id

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