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

March 11, 2013 updated by: OrthoCarolina Research Institute, Inc.

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: pre-operatively, 3 months, 6 months, and 1 year
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
Time Frame: pre-operatively, 3 months, 6 months, and 1 year
pre-operatively, 3 months, 6 months, and 1 year
Visual analog pain scale (VAS)
Time Frame: pre-operatively, 3 months, 6 months, and 1 year
pre-operatively, 3 months, 6 months, and 1 year
Hallux plantarflexion strength using the dynamometer
Time Frame: pre-operatively, 3 months, 6 months, and 1 year
pre-operatively, 3 months, 6 months, and 1 year
Patient Satisfaction
Time Frame: 1 year
1 year
Surgical complications
Time Frame: Date of Surgery
Date of Surgery
Postoperative complications
Time Frame: 3 months, 6 months, and 1 year
3 months, 6 months, and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OrthoCarolina Research Institute, Inc.

Investigators

  • Principal Investigator: Bruce E Cohen, MD, OrthoCarolina, P.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • 120808A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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