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

OrthoCarolina Research Institute, Inc.

Status and phase: Completed; Phase 4

Conditions: Chronic Insertional Achilles Tendonitis

Treatments: Procedure: Achilles decompression & debridement; Procedure: Achilles decompression and debridement with FHL transfer

Study type: Interventional

Funder types: Other

Identifiers

NCT00950053

120808A

Details and patient eligibility

About

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).

Enrollment: 52 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Achilles decompression & debridement

Active Comparator group

Treatment:

Procedure: Achilles decompression & debridement

Achilles decompression,debride&FHLtransf

Active Comparator group

Description:

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).

Treatment:

Procedure: Achilles decompression and debridement with FHL transfer