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NCT01319409 · ClinicalTrials.gov registry record · Phase 2
Single- vs. Double-Bundle ACL Reconstruction
A Phase 2 study of Anterior Cruciate Ligament Injury, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
- 1
- Study location
NCT01319409 is a Phase 2 study of Anterior Cruciate Ligament Injury that has completed, run by University of Pittsburgh. The registered enrollment target is 57 participants, below the 227-participant average among 8 other Anterior Cruciate Ligament Injury trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01319409, a Phase 2 study of Anterior Cruciate Ligament Injury, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this double-blind, randomized clinical trial to compare outcomes of single-bundle (SB) to anatomic double-bundle (DB) ACL reconstruction. We hypothesize that anatomically reconstructing both bundles of the ACL will lead to better restoration of healthy knee mechanics and clinical outcomes. In addition to standard clinical outcome measures, we will utilize a unique combination of high-speed biplane radiography (for highly accurate assessment of knee kinematics) and 3D imaging (MRI and CT, to define joint and cartilage morphology) to characterize joint kinematics and cartilage surface interactions during functional tasks. The specific aims of this study are to: Specific Aim 1: Determine if anatomic double-bundle ACL reconstruction restores normal dynamic knee function better than single-bundle ACL reconstruction. Hypothesis 1.1 Knee kinematics after anatomic double-bundle ACL reconstruction are more similar to the uninjured contra-lateral limb than after single-bundle ACL reconstruction, as measured with dynamic stereoradiography 6 and 24 months after surgery. Hypothesis 1.2 Graft elongation from 6 to 24 months after surgery is reduced with anatomic double-bundle ACL reconstruction in comparison to single-bundle ACL reconstruction, as measured with dynamic stereoradiography. Specific Aim 2: Determine if anatomic double-bundle ACL reconstruction results in better clinical outcomes than single-bundle ACL reconstruction. Hypothesis 2.1 Anatomic double-bundle ACL reconstruction will result in more symmetrical laxity and better range of motion and hop test scores in comparison to single-bundle ACL reconstruction. Hypothesis 2.2 In comparison to single-bundle ACL reconstruction, anatomic double-bundle ACL reconstruction will result in better patient-oriented outcomes, indicating fewer symptoms, a higher level of activity and more complete return to sport. Successful completion of these aims will provide quantitative evidence of the efficacy of anatomi
Conditions Studied
Interventions
- PROCEDURE Anatomic Double-Bundle ACL Reconstruction
- PROCEDURE Anatomic Single-Bundle ACL Reconstruction
Study Locations (1)
Pennsylvania
- UPMC Center for Sports Medicine - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2011-03 |
| Est. Completion | 2015-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01319409
The ClinicalTrials.gov registry entry for NCT01319409 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 227-participant average among 8 other Anterior Cruciate Ligament Injury trials with a reported enrollment target (75% lower). The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Anterior Cruciate Ligament Injury appearing as the primary indexed condition, and to 2 interventions - of which Anatomic Double-Bundle ACL Reconstruction is the first listed.
NCT01319409 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01319409 about?
NCT01319409 is a clinical study titled "Single- vs. Double-Bundle ACL Reconstruction". The purpose of this double-blind, randomized clinical trial to compare outcomes of single-bundle (SB) to anatomic double-bundle (DB) ACL reconstruction. We hypothesize that anatomically reconstructing both bundles of the ACL will lead to better restoration of healthy knee mechanics and clinical outc...
What is the current status of trial NCT01319409?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2011-03. Estimated completion is 2015-01.
What conditions does trial NCT01319409 study?
This clinical trial studies the following conditions: Anterior Cruciate Ligament Injury.
What interventions are being tested in trial NCT01319409?
The interventions under investigation include: Anatomic Double-Bundle ACL Reconstruction (PROCEDURE), Anatomic Single-Bundle ACL Reconstruction (PROCEDURE).
Who is sponsoring clinical trial NCT01319409?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01319409 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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