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Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty

Primary Purpose

Osteoarthritis, Knee

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Custom Patient Instrumentation

Conventional Instruments

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring 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

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

Center for Hip and Knee Surgery
Pinnacle Orthopaedics
Commonwealth Orthopaedics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

TruMatch® Personalized Solutions

Conventional Total Knee Replacement

Arm 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)

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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]

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].

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 .

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

Full Information

NCT ID

NCT01301950

First Posted

December 2, 2010

Last Updated

April 9, 2019

Sponsor

DePuy Orthopaedics

1. Study Identification

Unique Protocol Identification Number

NCT01301950

Brief Title

Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

May 1, 2010 (Actual)

Primary Completion Date

August 1, 2013 (Actual)

Study Completion Date

August 1, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

DePuy Orthopaedics

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TruMatch® Personalized Solutions

Arm Type

Active Comparator

Arm Description

Arm Title

Conventional Total Knee Replacement

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Custom Patient Instrumentation

Other Intervention Name(s)

TruMatch® Personalized Solutions

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Conventional Instruments

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Skin-to skin time for conventional versus TruMatch® primary total knee replacements (recorded by Investigator on Operative case report forms).

Time Frame

Intraoperative (Time from first incision to first stitch)

Secondary Outcome Measure Information:

Title

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

Description

Operating Room setup time for conventional versus TruMatch® primary total knee replacements as recorded by video time analysis [minutes]

Time Frame

Intraoperative (Operating Room cleaned up from previous case to surgical draping complete)

Title

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

Description

Turnover Time for conventional versus TruMatch® primary total knee replacements as recorded by video time analysis [minutes].

Time Frame

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

Title

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

Description

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

Time Frame

Intraoperative (Total duration of procedure)

Title

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

Time Frame

Intraoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carl Painter

Organizational Affiliation

Pinnacle Orthopaedics

Official's Role

Principal Investigator

Facility Information:

Facility Name

Center for Hip and Knee Surgery

City

Mooresville

State/Province

Indiana

ZIP/Postal Code

46158

Country

United States

Facility Name

Pinnacle Orthopaedics

City

Bartlesville

State/Province

Oklahoma

ZIP/Postal Code

74006

Country

United States

Facility Name

Commonwealth Orthopaedics

City

Reston

State/Province

Virginia

ZIP/Postal Code

20190

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty

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