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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01341509
Recruitment Status : Unknown
Verified June 2013 by OAD Orthopaedics.
Recruitment status was:  Recruiting
First Posted : April 25, 2011
Last Update Posted : June 11, 2013
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Achilles Tendinopathy Procedure: Flexor Hallucis Longus Tendon transfer Procedure: Transfer of the Flexor Hallucis Longus Tendon Procedure: No transfer of Flexor Hallucis Longus tendon Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Insertional Achilles Tendinopathy: A Randomized Trial to Evaluate the Effectiveness of Transferring the Flexor Hallucis Longus Tendon
Study Start Date : April 2011
Estimated Primary Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: FHL tendon transferred
Surgical group in which the FHL tendon was transferred
Procedure: Transfer of the Flexor Hallucis Longus Tendon
The Flexor Hallucis Longus Tendon was transferred during surgery for insertional achilles tendinopathy
Active Comparator: FHL tendon not transferred Procedure: Flexor Hallucis Longus Tendon transfer
The flexor hallucis longus tendon was transferred during surgery for insertional achilles tendinopathy
Procedure: No transfer of Flexor Hallucis Longus tendon
There was no transfer of the Flexor Hallucis Longus tendon in surgery for insertional achilles tendinopathy


Outcome Measures

Primary Outcome Measures :
  1. Statistical difference [ Time Frame: 2 years ]
    To detect a 20% difference in clinical outcomes between the two surgical groups.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01341509


Contacts
Contact: Marjorie L Delaney, APN 630-225-2554 marjorie.delaney@oadortho.com
Contact: Gregory P Witkowski, MD 630-225-2663 gregory.witkowski@oadortho.com

Locations
United States, Illinois
OAD Orthopaedics Recruiting
Warrenville, Illinois, United States, 60555
Contact: Marjorie L Delaney, APN    630-225-2554    marjorie.delaney@oadortho.com   
Contact: Gregory P Witkowski, MD    630-225-2663    gregory.witkowski@oadortho.com   
Principal Investigator: Gregory P Witkowski, MD         
Sub-Investigator: Jeffrey A Senall, md         
Sponsors and Collaborators
OAD Orthopaedics
Investigators
Principal Investigator: Gregory P Witkowski, MD OAD Orthopaedics
More Information

Additional Information:
Responsible Party: OAD Orthopaedics
ClinicalTrials.gov Identifier: NCT01341509     History of Changes
Other Study ID Numbers: GW100
First Posted: April 25, 2011    Key Record Dates
Last Update Posted: June 11, 2013
Last Verified: June 2013

Keywords provided by OAD Orthopaedics:
Surgical Treatment of Insertional Achilles Tendinopathy

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries