Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty

Completed · Not applicable

Conditions studied: Osteoarthritis, Knee

In brief

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

Key facts

Study ID

NCT01301950

Run by

DePuy Orthopaedics

People needed

30

Starts

2010-05-01

Expected to finish

2013-08-01

Last updated by the study team

2019-04-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 contracture are consistent with TruMatch™ instrumentation.

You may not qualify if…

• 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).

Where it is running

• Center for Hip and Knee Surgery — Mooresville, Indiana, United States
• Pinnacle Orthopaedics — Bartlesville, Oklahoma, United States
• Commonwealth Orthopaedics — Reston, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.