A Phase 4 interventional study of Achilles decompression & debridement and Achilles decompression and debridement with FHL transfer in Chronic Insertional Achilles Tendonitis, sponsored by OrthoCarolina Research Institute, Inc.. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2013-03-13.
Sponsored by OrthoCarolina Research Institute, Inc. · Phase 4, Interventional, and Treatment
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).
413 studies on the registry are indexed under Tendinopathy; 64 are open to participants now.
This study's enrollment of 52 is close to the median of 50 across 339 interventional studies indexed under Tendinopathy.
Browse Tendinopathy studies →OrthoCarolina Research Institute, Inc. is the lead sponsor of 34 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Procedure: Achilles decompression & debridement
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
surgical intervention
ankle plantar flexion strength measured using a handheld dynamometer
Time frame: pre-operatively, 3 months, 6 months, and 1 year
American Orthopaedic Foot and Ankle Society(AOFAS) Ankle-Hindfoot score
Time frame: 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
Hallux plantarflexion strength using the dynamometer
Time frame: pre-operatively, 3 months, 6 months, and 1 year
Patient Satisfaction
Time frame: 1 year
Surgical complications
Time frame: Date of Surgery
Postoperative complications
Time frame: 3 months, 6 months, and 1 year
This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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OrthoCarolina Research Institute, Inc.