Clinical trial NCT01301950: 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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2011-02-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Surgical Procedure Time to Compare Skin-to-Skin Time for Conventional Versus TruMatch® Primary Total Knee Replacements
timeFrame: Intraoperative (Time from first incision to first stitch)
Secondary outcomes:
measure: Operating Room Setup - Operating Room Cleaned up From Previous Case to Surgical Draping Complete
timeFrame: Intraoperative (Operating Room cleaned up from previous case to surgical draping complete)
measure: Turnover Time (Time to Clean Operating Room After Surgery is Completed)
timeFrame: Intraoperative (Time to clean Operating Room after surgery is completed)
measure: Costs Associated With Conventional Versus TruMatch® Total Knee Arthroplasty Surgical Procedures
timeFrame: Intraoperative (Total duration of procedure)
measure: To Compare the Differences in Operating Room Efficiency as a Function of Institution Type and Geographical Location
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Mooresville
country: United States
facility: Center for Hip and Knee Surgery
state: Indiana
city: Bartlesville
country: United States
facility: Pinnacle Orthopaedics
state: Oklahoma
city: Reston
country: United States
facility: Commonwealth Orthopaedics
state: Virginia
Study officials:
affiliation: Pinnacle Orthopaedics
name: Carl Painter
role: PRINCIPAL_INVESTIGATOR
References: