A Randomized Trial to Evaluate the Effectiveness of Transferring the Flexor Hallucis Longus Tendon
Insertional Achilles Tendinopathy: A Randomized Trial to Evaluate the Effectiveness of Transferring the Flexor Hallucis Longus Tendon
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 22, 2011
CompletedFirst Posted
Study publicly available on registry
April 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedJune 11, 2013
June 1, 2013
3 years
April 22, 2011
June 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Statistical difference
To detect a 20% difference in clinical outcomes between the two surgical groups.
2 years
Study Arms (2)
FHL tendon transferred
ACTIVE COMPARATORSurgical group in which the FHL tendon was transferred
FHL tendon not transferred
ACTIVE COMPARATORInterventions
The flexor hallucis longus tendon was transferred during surgery for insertional achilles tendinopathy
The Flexor Hallucis Longus Tendon was transferred during surgery for insertional achilles tendinopathy
There was no transfer of the Flexor Hallucis Longus tendon in surgery for insertional achilles tendinopathy
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients who have failed surgery for the same and patients with diabetic neuropathy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OAD Orthopaedicslead
Study Sites (1)
OAD Orthopaedics
Warrenville, Illinois, 60555, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory P Witkowski, MD
OAD Orthopaedics
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2011
First Posted
April 25, 2011
Study Start
April 1, 2011
Primary Completion
April 1, 2014
Last Updated
June 11, 2013
Record last verified: 2013-06