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Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty Using TruMatch Personalized Solutions Compared to Conventional Total Knee Arthroplasty

This study is currently Recruiting

September 2011 By DePuy Orthopaedics

First Recieved on December 2, 2010

Last Updated on September 30, 2011

Sponsor: DePuy Orthopaedics
Collaborators:
Information provided by: DePuy Orthopaedics
Identifier: NCT01301950

Purpose

This study is designed to compare the surgical efficiency of TruMatch? Personalized Solutions surgical technique compared to conventional (manual instruments) surgical technique. Specifically, the purpose of this study is to collect time data to enhance the existing economic model.

Study Type: Observational
Study Design: Observational Model: Case Control, Time Perspective: Prospective

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: - Subject is male or female and between the ages of 18 and 80 years old, inclusive. - Subject requires a primary total knee replacement and is considered by the Investigator to be suitable for the specific knee prosthesis identified in the protocol. - Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to DePuy - Subject, in the opinion of the Clinical Investigator, is able to understand this clinical investigation, and co-operate with investigational procedures. - Subject, who, in the opinion of the Clinical Investigator, are suitable for implantation using TruMatch? instrumentation. For example, no femoral nails/bone plates that extend into the knee, ie. within 8cm of joint line; no metal device that could cause CT scatter about the knee and no deformities greater than 15 degrees of fixed varus, valgus, or flexion are consistent with TruMatch? instrumentation. Exclusion Criteria: - The Subject is a woman who is pregnant or lactating. - The Subject has participated in a clinical investigation with an investigational product in the last 3 months. - The Subject is currently involved in any personal injury litigation, medical-legal or worker's compensations claims. - The Subject has previously had a prosthetic knee replacement device (any type) of the affected knee. - The Subject requires simultaneous bilateral total knee replacements. - The Subject had a contralateral TKA and that knee was previously entered in the study. - Subject in whom the surgeon intends to implant a knee prosthesis that is not in the PFC Sigma primary knee system. - Subject who has inflammatory arthritis. - Subject who has a Body Mass Index (BMI) of ? 40. (Please see Table 2-1: Definition of Terms, for BMI definition and calculation formulas).

Investigators

  • Investigator: Carl Painter - Principal Investigator - Pinnacle Orthopaedics

Locations

  • Pinnacle Orthopaedics

    Bartlesville, Oklahoma 74006 United States

  • Commonwealth Orthopaedics

    Reston, Virginia 20190 United States

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