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NCT00124462 · ClinicalTrials.gov registry record · NA
Trial of Realignment Therapy for Treatment of Medial Knee Osteoarthritis
A NA study, sponsored by Boston University.
- Completed
- Registry status
- NA
- Development phase
- 80
- Enrollment target
NCT00124462: Completed NA study, sponsored by Boston University.
NCT00124462 is a NA study that has completed, run by Boston University. The registered enrollment target is 80 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00124462, a NA study, has completed, sponsored by Boston University.
- COMPLETED
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
Study Summary
The overall objective of this 3-year project is to determine whether the provision of realignment therapy in patients with medial knee osteoarthritis (OA) relieves knee pain and improves function. The researchers will test the hypothesis that compared to control treatment, the use of realignment therapy (valgus knee brace + motion control shoes + orthosis) is effective in medial knee OA. The specific aims are: * To undertake a 30 week randomized crossover clinical trial in patients with medial knee osteoarthritis to determine whether provision of realignment therapy leads to lower pain scores and improved function during the time of this treatment than during the use of a placebo treatment; * To perform an open label follow-up study to track use and effectiveness of treatment. This project will be co-funded by DonJoy Orthopedic, a knee bracing company.
Primary Outcome
The WOMAC (Western Ontario and McMaster Osteoarthritis Index) is a widely used self-administered health status measure used in assessing pain, stiffness, and function in patients with OA of the hip or knee. It measures Pain (5 questions), Stiffness (2 questions), and Function (17 questions). The WOMAC pain scale ranges from 0-20. All the items are scored on a scale of 0-4 (0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely). Lower scores indicate lower levels of pain.
Interventions
- DEVICE Realigning knee brace and custom orthodic
- DEVICE Non realigning knee brace and flat orthodic
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2008-03 |
| Est. Completion | 2008-11 |
| Phase | NA |
What the finished NCT00124462 record still lists
NCT00124462 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Realigning knee brace and custom orthodic is the first listed.
NCT00124462 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00124462 about?
NCT00124462 is a clinical study titled "Trial of Realignment Therapy for Treatment of Medial Knee Osteoarthritis". The overall objective of this 3-year project is to determine whether the provision of realignment therapy in patients with medial knee osteoarthritis (OA) relieves knee pain and improves function. The researchers will test the hypothesis that compared to control treatment, the use of realignment the...
What is the current status of trial NCT00124462?
This trial is currently completed. It is a NA study. The enrollment target is 80 participants. The study started on 2008-03. Estimated completion is 2008-11.
What interventions are being tested in trial NCT00124462?
The interventions under investigation include: Realigning knee brace and custom orthodic (DEVICE), Non realigning knee brace and flat orthodic (DEVICE).
Who is sponsoring clinical trial NCT00124462?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00124462's enrollment target sits among peer trials
80 994th of 2000 higher than 941 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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