Chronic Insertional Achilles Tendonitis Treated With or Without Flexor Hallucis Longus Tendon Transfer
Primary Purpose
Chronic Insertional Achilles Tendonitis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Achilles decompression & debridement
Achilles decompression and debridement with FHL transfer
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Insertional Achilles Tendonitis
Eligibility Criteria
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
Sites / Locations
- OrthoCarolina, PA
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Achilles decompression & debridement
Achilles decompression,debride&FHLtransf
Arm 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).
Outcomes
Primary Outcome Measures
ankle plantar flexion strength measured using a handheld dynamometer
Secondary Outcome Measures
American Orthopaedic Foot and Ankle Society(AOFAS) Ankle-Hindfoot score
Visual analog pain scale (VAS)
Hallux plantarflexion strength using the dynamometer
Patient Satisfaction
Surgical complications
Postoperative complications
Full Information
NCT ID
NCT00950053
First Posted
July 29, 2009
Last Updated
March 11, 2013
Sponsor
OrthoCarolina Research Institute, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00950053
Brief Title
Chronic Insertional Achilles Tendonitis Treated With or Without Flexor Hallucis Longus Tendon Transfer
Official Title
Chronic Insertional Achilles Tendonitis Treated With or Without Flexor Hallucis Longus Tendon Transfer: A Prospective, Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OrthoCarolina Research Institute, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Insertional Achilles Tendonitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Achilles decompression & debridement
Arm Type
Active Comparator
Arm Title
Achilles decompression,debride&FHLtransf
Arm Type
Active Comparator
Arm 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).
Intervention Type
Procedure
Intervention Name(s)
Achilles decompression & debridement
Intervention Description
Surgical intervention
Intervention Type
Procedure
Intervention Name(s)
Achilles decompression and debridement with FHL transfer
Intervention Description
surgical intervention
Primary Outcome Measure Information:
Title
ankle plantar flexion strength measured using a handheld dynamometer
Time Frame
pre-operatively, 3 months, 6 months, and 1 year
Secondary Outcome Measure Information:
Title
American Orthopaedic Foot and Ankle Society(AOFAS) Ankle-Hindfoot score
Time Frame
pre-operatively, 3 months, 6 months, and 1 year
Title
Visual analog pain scale (VAS)
Time Frame
pre-operatively, 3 months, 6 months, and 1 year
Title
Hallux plantarflexion strength using the dynamometer
Time Frame
pre-operatively, 3 months, 6 months, and 1 year
Title
Patient Satisfaction
Time Frame
1 year
Title
Surgical complications
Time Frame
Date of Surgery
Title
Postoperative complications
Time Frame
3 months, 6 months, and 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce E Cohen, MD
Organizational Affiliation
OrthoCarolina, P.A.
Official's Role
Principal Investigator
Facility Information:
Facility Name
OrthoCarolina, PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Chronic Insertional Achilles Tendonitis Treated With or Without Flexor Hallucis Longus Tendon Transfer
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