Chronic Insertional Achilles Tendonitis Treated With or Without Flexor Hallucis Longus Tendon Transfer

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Achilles tendon debridement and decompression augmented with flexor hallucis longus (FHL) tendon transfer results in improved clinical and functional outcome as measured by ankle plantar flexion strength and American Orthopedic Foot and Ankle Society (AOFAS) score compared to debridement and decompression alone in patients over 50 years of age with chronic insertional Achilles tendinosis. 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).

Official Title
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Chronic Insertional Achilles Tendonitis Treated With or Without Flexor Hallucis Longus Tendon Transfer: A Prospective, Randomized, Controlled Trial

Conditions
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Chronic Insertional Achilles Tendonitis

Intervention / Treatment
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* Procedure: Achilles decompression & debridement
* Procedure: Achilles decompression and debridement with FHL transfer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 50 years of age or older 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: Patients less than 50 years of age upon presentation 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Achilles decompression & debridement<br> | Procedure: Achilles decompression & debridement<br>* Surgical intervention<br>|
| Active Comparator: Achilles decompression,debride&FHLtransf<br>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). | Procedure: Achilles decompression and debridement with FHL transfer<br>* surgical intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ankle plantar flexion strength measured using a handheld dynamometer |  | pre-operatively, 3 months, 6 months, and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Orthopaedic Foot and Ankle Society(AOFAS) Ankle-Hindfoot score |  | pre-operatively, 3 months, 6 months, and 1 year | 
| Visual analog pain scale (VAS) |  | pre-operatively, 3 months, 6 months, and 1 year | 
| Hallux plantarflexion strength using the dynamometer |  | pre-operatively, 3 months, 6 months, and 1 year | 
| Patient Satisfaction |  | 1 year | 
| Surgical complications |  | Date of Surgery | 
| Postoperative complications |  | 3 months, 6 months, and 1 year |