Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01301950
• Other study ID #: 08004
• Status: Completed
• Phase: N/A
• Start date: May 1, 2010
• Est. completion date: August 1, 2013

Study information

• Verified date: April 2019
• Source: DePuy Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 1, 2013
• Est. primary completion date: August 1, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
United States	Pinnacle Orthopaedics	Bartlesville	Oklahoma
United States	Center for Hip and Knee Surgery	Mooresville	Indiana
United States	Commonwealth Orthopaedics	Reston	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	To Compare the Differences in Operating Room Efficiency as a Function of Institution Type and Geographical Location		Intraoperative