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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Achilles decompression & debridement | Active Comparator |
| |
| Achilles decompression,debride&FHLtransf | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Achilles decompression & debridement | Procedure | Surgical intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| ankle plantar flexion strength measured using a handheld dynamometer | pre-operatively, 3 months, 6 months, and 1 year |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce E Cohen, MD | OrthoCarolina, P.A. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OrthoCarolina, PA | Charlotte | North Carolina | 28203 | United States |
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| Achilles decompression and debridement with FHL transfer | Procedure | surgical intervention |
|
| 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 |
| ID | Term |
|---|---|
| D003646 | Debridement |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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