Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty

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 surgical technique. Specifically, the purpose of this study is to collect time data to enhance the existing economic model.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Other: Custom Patient Instrumentation; Other: Conventional Instruments

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Mooresville, Indiana, United States, 46158
      • Center for Hip and Knee Surgery
  • Oklahoma
    • Bartlesville, Oklahoma, United States, 74006
      • Pinnacle Orthopaedics
  • Virginia
    • Reston, Virginia, United States, 20190
      • Commonwealth Orthopaedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TruMatch® Personalized Solutions; Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch® Personalized Solutions (Custom Patient Instrumentation)	Other: Custom Patient Instrumentation; TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation (CPI). TruMatch™ is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patient's distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon; Other Names: TruMatch® Personalized Solutions
Active Comparator: Conventional Total Knee Replacement; Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments	Other: Conventional Instruments; Total Knee Arthroplasty implanted using conventional instruments (non-CPI) and surgical technique.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operating Room Setup - 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]	Intraoperative (Operating Room cleaned up from previous case to surgical draping complete)
Turnover Time (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].	Intraoperative (Time to clean Operating Room after surgery is completed)
Costs Associated With Conventional Versus TruMatch® Total Knee Arthroplasty Surgical Procedures	Compare costs associated with surgery using conventional surgical technique versus TruMatch® primary total knee replacements .	Intraoperative (Total duration of procedure)
To Compare the Differences in Operating Room Efficiency as a Function of Institution Type and Geographical Location		Intraoperative

Collaborators and Investigators

• Sponsor: DePuy Orthopaedics
• Investigators: Principal Investigator: Carl Painter, Pinnacle Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2010
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: December 2, 2010
• First Submitted That Met QC Criteria: February 22, 2011
• First Posted (Estimate): February 23, 2011

Study Record Updates

• Last Update Posted (Actual): April 10, 2019
• Last Update Submitted That Met QC Criteria: April 9, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Total Knee Replacement; Arthroplasties, Knee Replacement; Knee Replacement, Total; Arthroplasties, Replacement, Knee; Arthroplasty, Knee Replacement; Knee Replacement Arthroplasties; Knee Replacement Arthroplasty; Replacement Arthroplasties, Knee; Replacement Arthroplasty, Knee; Replacement, Total Knee
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 08004