Skip to main content
OpenTrials
Completed

NCT Number: NCT01301950

Comparison of Surgical Time and Efficiency of 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Hip and Knee Surgery, Mooresville, Indiana, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Other names: TruMatch® Personalized Solutions

Conventional Instruments

Other

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

Primary outcomes

  1. Surgical Procedure Time to Compare Skin-to-Skin Time for Conventional Versus TruMatch® Primary Total Knee Replacements

    Time frame: 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 outcomes

  1. Operating Room Setup - Operating Room Cleaned up From Previous Case to Surgical Draping Complete

    Time frame: 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]

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

    Time frame: 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].

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

    Time frame: Intraoperative (Total duration of procedure)

    Compare costs associated with surgery using conventional surgical technique versus TruMatch® primary total knee replacements .

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

    Time frame: Intraoperative

Sponsors and collaborators

Lead sponsor

DePuy Orthopaedics

Industry

Registry information

Official study title

Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty Using TruMatch® Personalized Solutions Compared to Conventional Total Knee Arthroplasty

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Feb 23, 2011
Registry last updated
Apr 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.