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

Phase 4

Completed

• Conditions: Chronic Insertional Achilles Tendonitis
• Interventions: Procedure: Achilles decompression & debridement; Procedure: Achilles decompression and debridement with FHL transfer

• Registration Number: NCT00950053
• Lead Sponsor: OrthoCarolina Research Institute, Inc.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-07-29
• Study First Submitted QC: 2009-07-30
• Study First Posted: 2009-07-31
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-11
• Last Update Posted: 2013-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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)

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Achilles decompression & debridement	Achilles decompression & debridement	-
Achilles decompression,debride&FHLtransf	Achilles decompression and debridement with FHL transfer	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).

Primary Outcome Measures

Name	Time	Method
ankle plantar flexion strength measured using a handheld dynamometer	pre-operatively, 3 months, 6 months, and 1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

OrthoCarolina, PA; 🇺🇸 Charlotte, North Carolina, United States