Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty

NCT01301950 | Completed Results

• 1 other identifier: 08004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Osteoarthritis, Knee

Keywords

Arthroplasties, Knee Replacement; Arthroplasties, Replacement, Knee; Arthroplasty, Knee Replacement; Knee Replacement Arthroplasties; Knee Replacement Arthroplasty; Knee Replacement, Total; Replacement Arthroplasties, Knee; Replacement Arthroplasty, Knee; Replacement, Total Knee; Total Knee Replacement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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)

• Turnover Time (Time to Clean Operating Room After Surgery is Completed)

  Intraoperative (Time to clean Operating Room after surgery is completed)

• Costs Associated With Conventional Versus TruMatch® Total Knee Arthroplasty Surgical Procedures

  Intraoperative (Total duration of procedure)

• To Compare the Differences in Operating Room Efficiency as a Function of Institution Type and Geographical Location

  Intraoperative

Study Arms (2)

TruMatch® Personalized Solutions

ACTIVE COMPARATOR

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

Conventional Total Knee Replacement

ACTIVE COMPARATOR

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

Other: Conventional Instruments

Interventions

Custom Patient Instrumentation OTHER

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

Also known as: TruMatch® Personalized Solutions

TruMatch® Personalized Solutions

Conventional Instruments OTHER

Total Knee Arthroplasty implanted using conventional instruments (non-CPI) and surgical technique.

Conventional Total Knee Replacement

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• DePuy Orthopaedics: lead

Study Sites (3)

Center for Hip and Knee Surgery

Mooresville, Indiana, 46158, United States

Location

Pinnacle Orthopaedics

Bartlesville, Oklahoma, 74006, United States

Location

Commonwealth Orthopaedics

Reston, Virginia, 20190, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

A statistically powered sample size was not obtained; Two secondary objectives (compare costs \& compare differences in OR efficiency as a function of institution type \& geographic location) could not be assessed as originally intended by the protocol

Results Point of Contact

• Title: Sam Himden, Clinical Portfolio Leader
• Organization: DePuy Synthes

shimden@its.jnj.com

574-372-7231

Study Officials

• Carl Painter

  Pinnacle Orthopaedics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2010
• First Posted: February 23, 2011
• Study Start: May 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: April 10, 2019
• Results First Posted: September 5, 2014

Record last verified: 2019-04

Locations

US (3)