Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty

Launched by DEPUY ORTHOPAEDICS · Feb 22, 2011

Keywords

ClinConnect Summary

The study is designed as a prospective, multi-center, controlled, non-randomized, clinical investigation to compare the efficiency of TruMatch® Personalized Solutions surgical technique compared to conventional surgical technique.

Gender

ALL

Eligibility 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 contracture 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).