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

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

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).

Study Overview

• Status: Completed
• Conditions: Chronic Insertional Achilles Tendonitis
• Intervention / Treatment: Procedure: Achilles decompression & debridement; Procedure: Achilles decompression and debridement with FHL transfer

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • OrthoCarolina, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Achilles decompression & debridement	Procedure: Achilles decompression & debridement; Surgical intervention
Active Comparator: 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).	Procedure: Achilles decompression and debridement with FHL transfer; surgical intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: OrthoCarolina Research Institute, Inc.
• Investigators: Principal Investigator: Bruce E Cohen, MD, OrthoCarolina, P.A.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: July 29, 2009
• First Submitted That Met QC Criteria: July 30, 2009
• First Posted (Estimate): July 31, 2009

Study Record Updates

• Last Update Posted (Estimate): March 13, 2013
• Last Update Submitted That Met QC Criteria: March 11, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Bone Diseases; Hyperostosis; Tendinopathy; Bursitis; Exostoses
• Other Study ID Numbers: 120808A