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NCT01108237 · ClinicalTrials.gov registry record · NA
Alignment Comparison Between TruMatch™ Personalized Solutions and Conventional Total Knee Replacement Instrumentation
A NA study of Osteoarthritis, Knee, sponsored by DePuy Orthopaedics.
- Completed
- Registry status
- NA
- Development phase
- 78
- Enrollment target
- 4
- Study locations
NCT01108237: Completed NA study of Osteoarthritis, Knee, sponsored by DePuy Orthopaedics.
NCT01108237 is a NA study of Osteoarthritis, Knee that has completed, run by DePuy Orthopaedics. The registered enrollment target is 78 participants, below the 497-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (84% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01108237, a NA study of Osteoarthritis, Knee, has completed, sponsored by DePuy Orthopaedics.
- COMPLETED
- Registry status
- NA
- Development phase
- 78 participants
- Enrollment target
- 4
- Study locations
Study Summary
This investigation is intended to provide clinical information about alignment using TruMatch™ and to compare the results to a conventional total knee replacement. TruMatch™ will be compared to a historical control study, which compares alignment results of computer aided surgery (CAS) and conventional surgical techniques. The purpose of this investigation is to determine whether TruMatch™ alignment is non-inferior to alignment achieved with conventional instrumentation. This investigation will compare long leg alignment in total knee replacement achieved by the two types of procedures. Radiographic analysis will be performed by the same independent radiographic reviewer as the historical control study.
Primary Outcome
Limb alignment in TKR is important for accurate implant positioning. It is measured by looking at the mechanical axis of the limb. This axis is an imaginary line that starts at center of the femoral head and ends in the center of the talus. In a knee with normal alignment, this line (axis) passes near the joint center. Before surgery, the planned joint angle is recorded. This study measured the difference between the mechanical axis angle reached after surgery and the planned angle. Subjects wit
Conditions Studied
Interventions
- OTHER TruMatch™ Personalized Solutions
- DEVICE Total Knee Arthroplasty with Conventional Instrumentation.
Study Locations (4)
Maryland
- Towson Orthopaedic Associates - Baltimore
Minnesota
- Summit Orthopaedics, LTD - Saint Paul
North Carolina
- OrthoCarolina - Charlotte
Washington
- Valley Orthopaedic Associates - Renton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2009-10-01 |
| Est. Completion | 2011-03-01 |
| Phase | NA |
What the finished NCT01108237 record still lists
NCT01108237 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 497-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Osteoarthritis, Knee appearing as the primary indexed condition, and to 2 interventions - of which TruMatch™ Personalized Solutions is the first listed.
NCT01108237 reports a single indexed study location in Maryland, Minnesota, North Carolina.
Frequently Asked Questions
What is clinical trial NCT01108237 about?
NCT01108237 is a clinical study titled "Alignment Comparison Between TruMatch™ Personalized Solutions and Conventional Total Knee Replacement Instrumentation". This investigation is intended to provide clinical information about alignment using TruMatch™ and to compare the results to a conventional total knee replacement. TruMatch™ will be compared to a historical control study, which compares alignment results of computer aided surgery (CAS) and conventio...
What is the current status of trial NCT01108237?
This trial is currently completed. It is a NA study. The enrollment target is 78 participants. The study started on 2009-10-01. Estimated completion is 2011-03-01.
What conditions does trial NCT01108237 study?
This clinical trial studies the following conditions: Osteoarthritis, Knee.
What interventions are being tested in trial NCT01108237?
The interventions under investigation include: TruMatch™ Personalized Solutions (OTHER), Total Knee Arthroplasty with Conventional Instrumentation. (DEVICE).
Who is sponsoring clinical trial NCT01108237?
This trial is sponsored by DePuy Orthopaedics, which has 38 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01108237 being conducted?
This trial has 4 study locations across Maryland, Minnesota, North Carolina, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01108237's enrollment target sits among peer trials
78 76th of 112 higher than 37 of 112 other Osteoarthritis, Knee trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis, Knee 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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