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NCT00950053 · ClinicalTrials.gov registry record · Phase 4
Chronic Insertional Achilles Tendonitis Treated With or Without Flexor Hallucis Longus Tendon Transfer
A Phase 4 study, sponsored by OrthoCarolina Research Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 52
- Enrollment target
NCT00950053 is a Phase 4 study that has completed, run by OrthoCarolina Research Institute. The registered enrollment target is 52 participants.
The verdict
NCT00950053, a Phase 4 study, has completed, sponsored by OrthoCarolina Research Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 52 participants
- Enrollment target
Study 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
- PROCEDURE Achilles decompression & debridement
- PROCEDURE Achilles decompression and debridement with FHL transfer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2008-12 |
| Est. Completion | 2012-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00950053
The ClinicalTrials.gov registry entry for NCT00950053 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OrthoCarolina Research Institute, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Achilles decompression & debridement is the first listed.
NCT00950053 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00950053 about?
NCT00950053 is a clinical study titled "Chronic Insertional Achilles Tendonitis Treated With or Without Flexor Hallucis Longus Tendon Transfer". 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...
What is the current status of trial NCT00950053?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 52 participants. The study started on 2008-12. Estimated completion is 2012-06.
What interventions are being tested in trial NCT00950053?
The interventions under investigation include: Achilles decompression & debridement (PROCEDURE), Achilles decompression and debridement with FHL transfer (PROCEDURE).
Who is sponsoring clinical trial NCT00950053?
This trial is sponsored by OrthoCarolina Research Institute, which has 28 total clinical trials registered on ClinicalTrials.gov.
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