Chronic Insertional Achilles Tendonitis Clinical Trial
Official title:
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).
| Status | Completed |
| Enrollment | 52 |
| Est. completion date | June 2012 |
| Est. primary completion date | June 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | OrthoCarolina, PA | Charlotte | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| OrthoCarolina Research Institute, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | ankle plantar flexion strength measured using a handheld dynamometer | pre-operatively, 3 months, 6 months, and 1 year | No | |
| Secondary | American Orthopaedic Foot and Ankle Society(AOFAS) Ankle-Hindfoot score | pre-operatively, 3 months, 6 months, and 1 year | No | |
| Secondary | Visual analog pain scale (VAS) | pre-operatively, 3 months, 6 months, and 1 year | No | |
| Secondary | Hallux plantarflexion strength using the dynamometer | pre-operatively, 3 months, 6 months, and 1 year | No | |
| Secondary | Patient Satisfaction | 1 year | No | |
| Secondary | Surgical complications | Date of Surgery | No | |
| Secondary | Postoperative complications | 3 months, 6 months, and 1 year | No |