Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Other: Conventional Instruments; Other: Custom Patient Instrumentation

• Registration Number: NCT01301950
• Lead Sponsor: DePuy Orthopaedics

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2010-05-01
• Study First Submitted: 2010-12-02
• Study First Submitted QC: 2011-02-22
• Study First Posted: 2011-02-23
• Primary Completion: 2013-08-01
• Study Completion: 2013-08-01
• Results First Submitted: 2014-06-25
• Results First Submitted QC: 2014-08-26
• Results First Posted: 2014-09-05
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Total Knee Replacement	Conventional Instruments	Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
TruMatch® Personalized Solutions	Custom Patient Instrumentation	Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch® Personalized Solutions (Custom Patient Instrumentation)

Primary Outcome Measures

Name	Time	Method
Surgical Procedure Time to Compare Skin-to-Skin Time for Conventional Versus TruMatch® Primary Total Knee Replacements	Intraoperative (Time from first incision to first stitch)	Skin-to skin time for conventional versus TruMatch® primary total knee replacements (recorded by Investigator on Operative case report forms).

Secondary Outcome Measures

Name	Time	Method
Costs Associated With Conventional Versus TruMatch® Total Knee Arthroplasty Surgical Procedures	Intraoperative (Total duration of procedure)	Compare costs associated with surgery using conventional surgical technique versus TruMatch® primary total knee replacements .
To Compare the Differences in Operating Room Efficiency as a Function of Institution Type and Geographical Location	Intraoperative
Turnover Time (Time to Clean Operating Room After Surgery is Completed)	Intraoperative (Time to clean Operating Room after surgery is completed)	Turnover Time for conventional versus TruMatch® primary total knee replacements as recorded by video time analysis \[minutes\].
Operating Room Setup - Operating Room Cleaned up From Previous Case to Surgical Draping Complete	Intraoperative (Operating Room cleaned up from previous case to surgical draping complete)	Operating Room setup time for conventional versus TruMatch® primary total knee replacements as recorded by video time analysis \[minutes\]

Trial Locations

Locations (3)

Pinnacle Orthopaedics; 🇺🇸 Bartlesville, Oklahoma, United States

Center for Hip and Knee Surgery; 🇺🇸 Mooresville, Indiana, United States

Commonwealth Orthopaedics; 🇺🇸 Reston, Virginia, United States