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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00950053
Enrollment
52
Registered
2009-07-31
Start date
2008-12-31
Completion date
2012-06-30
Last updated
2013-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Insertional Achilles Tendonitis

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).

Interventions

PROCEDUREAchilles decompression & debridement

Surgical intervention

PROCEDUREAchilles decompression and debridement with FHL transfer

surgical intervention

Sponsors

OrthoCarolina Research Institute, Inc.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
ankle plantar flexion strength measured using a handheld dynamometerpre-operatively, 3 months, 6 months, and 1 year

Secondary

MeasureTime frame
Visual analog pain scale (VAS)pre-operatively, 3 months, 6 months, and 1 year
Hallux plantarflexion strength using the dynamometerpre-operatively, 3 months, 6 months, and 1 year
American Orthopaedic Foot and Ankle Society(AOFAS) Ankle-Hindfoot scorepre-operatively, 3 months, 6 months, and 1 year
Surgical complicationsDate of Surgery
Postoperative complications3 months, 6 months, and 1 year
Patient Satisfaction1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026