Chronic Insertional Achilles Tendonitis Treated With or Without Flexor Hallucis Longus Tendon Transfer
NCT ID: NCT00950053
Last Updated: 2013-03-13
Study Results
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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COMPLETED
PHASE4
52 participants
INTERVENTIONAL
2008-12-31
2012-06-30
Brief Summary
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H0: There will be no difference in ankle plantar flexion strength measured using a handheld dynamometer between patients randomized to achilles tendon decompression and debridement alone (Group 1) and patients randomized to achilles tendon decompression and debridement augmented with FHL transfer (Group 2).
HA: Patients randomized to achilles tendon decompression and debridement alone (Group 1) will have less ankle plantar flexion strength compared to patients randomized to achilles tendon decompression and debridement augmented with FHL transfer (Group 2).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Achilles decompression & debridement
Achilles decompression & debridement
Surgical intervention
Achilles decompression,debride&FHLtransf
Achilles tendon decompression and debridement augmented with FHL transfer. The preferred skin incision will be followed by central-splitting Achilles debridement, resection of a Haglund's lesion if present and pathologic, followed by FHL harvest for patients in group 2. The fixation technique in group 2 will utilize an interference screw for the FHL. For all patients, the Achilles will be reattached with lateral and medial suture anchors (just distal to interference screw in FHL patients).
Achilles decompression and debridement with FHL transfer
surgical intervention
Interventions
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Achilles decompression & debridement
Surgical intervention
Achilles decompression and debridement with FHL transfer
surgical intervention
Eligibility Criteria
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Inclusion Criteria
* Patients diagnosed with chronic insertional Achilles tendonitis
* Failed greater than 3 months of conservative treatment (activity and shoe modification, heel lifts, non-steroidal anti-inflammatory medications, stretching exercises, and formal physical therapy)
Exclusion Criteria
* Females of child-bearing potential
* Patients who have a history of ipsilateral Achilles tendon rupture
* History of infection in the same lower extremity
* Patients unable to undergo MRI scan
50 Years
ALL
No
Sponsors
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OrthoCarolina Research Institute, Inc.
OTHER
Responsible Party
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Principal Investigators
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Bruce E Cohen, MD
Role: PRINCIPAL_INVESTIGATOR
OrthoCarolina, P.A.
Locations
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OrthoCarolina, PA
Charlotte, North Carolina, United States
Countries
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Other Identifiers
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120808A
Identifier Type: -
Identifier Source: org_study_id
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