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

Primary Purpose

Achilles Tendinopathy

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Flexor Hallucis Longus Tendon transfer
Transfer of the Flexor Hallucis Longus Tendon
No transfer of Flexor Hallucis Longus tendon
Sponsored by
OAD Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achilles Tendinopathy focused on measuring Surgical Treatment of Insertional Achilles Tendinopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • OAD OrthopaedicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

FHL tendon transferred

FHL tendon not transferred

Arm Description

Surgical group in which the FHL tendon was transferred

Outcomes

Primary Outcome Measures

Statistical difference
To detect a 20% difference in clinical outcomes between the two surgical groups.

Secondary Outcome Measures

Full Information

First Posted
April 22, 2011
Last Updated
June 10, 2013
Sponsor
OAD Orthopaedics
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1. Study Identification

Unique Protocol Identification Number
NCT01341509
Brief Title
A Randomized Trial to Evaluate the Effectiveness of Transferring the Flexor Hallucis Longus Tendon
Official Title
Insertional Achilles Tendinopathy: A Randomized Trial to Evaluate the Effectiveness of Transferring the Flexor Hallucis Longus Tendon
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OAD Orthopaedics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendinopathy
Keywords
Surgical Treatment of Insertional Achilles Tendinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FHL tendon transferred
Arm Type
Active Comparator
Arm Description
Surgical group in which the FHL tendon was transferred
Arm Title
FHL tendon not transferred
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Flexor Hallucis Longus Tendon transfer
Intervention Description
The flexor hallucis longus tendon was transferred during surgery for insertional achilles tendinopathy
Intervention Type
Procedure
Intervention Name(s)
Transfer of the Flexor Hallucis Longus Tendon
Intervention Description
The Flexor Hallucis Longus Tendon was transferred during surgery for insertional achilles tendinopathy
Intervention Type
Procedure
Intervention Name(s)
No transfer of Flexor Hallucis Longus tendon
Intervention Description
There was no transfer of the Flexor Hallucis Longus tendon in surgery for insertional achilles tendinopathy
Primary Outcome Measure Information:
Title
Statistical difference
Description
To detect a 20% difference in clinical outcomes between the two surgical groups.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marjorie L Delaney, APN
Phone
630-225-2554
Email
marjorie.delaney@oadortho.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gregory P Witkowski, MD
Phone
630-225-2663
Email
gregory.witkowski@oadortho.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory P Witkowski, MD
Organizational Affiliation
OAD Orthopaedics
Official's Role
Principal Investigator
Facility Information:
Facility Name
OAD Orthopaedics
City
Warrenville
State/Province
Illinois
ZIP/Postal Code
60555
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marjorie L Delaney, APN
Phone
630-225-2554
Email
marjorie.delaney@oadortho.com
First Name & Middle Initial & Last Name & Degree
Gregory P Witkowski, MD
Phone
630-225-2663
Email
gregory.witkowski@oadortho.com
First Name & Middle Initial & Last Name & Degree
Gregory P Witkowski, MD
First Name & Middle Initial & Last Name & Degree
Jeffrey A Senall, md

12. IPD Sharing Statement

Links:
URL
http://www.oadortho.com/centers/research.htm
Description
Related Info

Learn more about this trial

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

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