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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by OAD Orthopaedics
Sponsor:
Information provided by (Responsible Party):
OAD Orthopaedics
ClinicalTrials.gov Identifier:
NCT01341509
First received: April 22, 2011
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Insertional Achilles Tendinopathy: A Randomized Trial to Evaluate the Effectiveness of Transferring the Flexor Hallucis Longus Tendon

Resource links provided by NLM:


Further study details as provided by OAD Orthopaedics:

Primary Outcome Measures:
  • Statistical difference [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To detect a 20% difference in clinical outcomes between the two surgical groups.


Estimated Enrollment: 20
Study Start Date: April 2011
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: OAD Orthopaedics
ClinicalTrials.gov Identifier: NCT01341509     History of Changes
Other Study ID Numbers: GW100
Study First Received: April 22, 2011
Last Updated: June 10, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 16, 2014