Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty

DePuy Synthes

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Other: Custom Patient Instrumentation; Other: Conventional Instruments

Study type: Interventional

Funder types: Industry

Identifiers

NCT01301950

08004

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

TruMatch® Personalized Solutions

Active Comparator group

Description:

Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch® Personalized Solutions (Custom Patient Instrumentation)

Treatment:

Other: Custom Patient Instrumentation

Conventional Total Knee Replacement

Active Comparator group

Description:

Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments

Treatment:

Other: Conventional Instruments