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NCT01375231 · ClinicalTrials.gov registry record · Phase 4
Anatomic Reconstruction of the Patellofemoral Joint
A Phase 4 study of Knee Replacement Surgery, sponsored by OrthoCarolina Research Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT01375231: Completed Phase 4 study of Knee Replacement Surgery, sponsored by OrthoCarolina Research Institute.
NCT01375231 is a Phase 4 study of Knee Replacement Surgery that has completed, run by OrthoCarolina Research Institute. The registered enrollment target is 52 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01375231, a Phase 4 study of Knee Replacement Surgery, has completed, sponsored by OrthoCarolina Research Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators posit that it would be advantageous to reproduce the height of the entire patellofemoral joint in order to maintain the lever arm of the quadriceps mechanism at its preoperative level. Failure to do this may cause the quadriceps mechanism to be inefficient. For example the quadriceps mechanism would have to work harder if the total patellofemoral (PF) height is diminished. Alternatively, diminished motion or increased patellar strain may occur if the overall PF height is increased. The investigators theorize that either of these sizing errors could lead to anterior knee pain. The purpose of this study is to compare the clinical outcomes between two surgical techniques: 1) a technique of reproducing the total PF joint on both sides of the articulation (Group 1) and 2) the traditional technique of reproducing only the patellar thickness on one side of the joint (Group 2).
Primary Outcome
Measured by visual analog scale
Conditions Studied
Interventions
- PROCEDURE Measured Resection of patellofemoral joint
- PROCEDURE Measured resection of patella
Study Locations (1)
North Carolina
- OrthoCarolina Research Institute/OrthoCarolina - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2011-06 |
| Est. Completion | 2013-05 |
| Phase | Phase 4 |
What the finished NCT01375231 record still lists
NCT01375231 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Knee Replacement Surgery appearing as the primary indexed condition, and to 2 interventions - of which Measured Resection of patellofemoral joint is the first listed.
NCT01375231 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT01375231 about?
NCT01375231 is a clinical study titled "Anatomic Reconstruction of the Patellofemoral Joint". The investigators posit that it would be advantageous to reproduce the height of the entire patellofemoral joint in order to maintain the lever arm of the quadriceps mechanism at its preoperative level. Failure to do this may cause the quadriceps mechanism to be inefficient. For example the quadrice...
What is the current status of trial NCT01375231?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 52 participants. The study started on 2011-06. Estimated completion is 2013-05.
What conditions does trial NCT01375231 study?
This clinical trial studies the following conditions: Knee Replacement Surgery.
What interventions are being tested in trial NCT01375231?
The interventions under investigation include: Measured Resection of patellofemoral joint (PROCEDURE), Measured resection of patella (PROCEDURE).
Who is sponsoring clinical trial NCT01375231?
This trial is sponsored by OrthoCarolina Research Institute, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01375231 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01375231's enrollment target sits among peer trials
52 1233rd of 2000 higher than 753 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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