Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty



Status:Completed
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 80
Updated:3/1/2014
Start Date:May 2010
End Date:August 2013
Contact:Sam Himden, BA
Email:Shimden@its.jnj.com
Phone:574-372-7231

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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 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.

The study is designed as a prospective, multi-center, non-randomized, clinical investigation
to determine whether TruMatch™ alignment is non-inferior to alignment achieved in a recently
completed study (historical control) with conventional instrumentation.

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).
We found this trial at
3
sites
Mooresville, Indiana 46158
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Mooresville, IN
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Bartlesville, Oklahoma 74006
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Bartlesville, OK
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Reston, Virginia 20190
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Reston, VA
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