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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 is a NA study of Osteoarthritis, Knee that has completed, run by DePuy Orthopaedics. The registered enrollment target is 78 participants, below the 579-participant average among 91 other Osteoarthritis, Knee trials with a reported enrollment target (87% lower). The trial reports 4 study locations across 4 states.

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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.

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

FieldValue
Enrollment Target 78 participants
Start Date 2009-10-01
Est. Completion 2011-03-01
Phase NA

Sponsor

DePuy Orthopaedics

38 total trials

What the Registry Record Tells You About NCT01108237

The ClinicalTrials.gov registry entry for NCT01108237 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 579-participant average among 91 other Osteoarthritis, Knee trials with a reported enrollment target (87% lower). The listed sponsor is DePuy Orthopaedics, which has 38 total studies on file at ClinicalTrials.gov.

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 4 study locations spanning 4 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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