N/A
Completed N=30
Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty
Osteoarthritis, Knee
Source: ClinicalTrials.gov NCT01301950 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: Surgical Procedure Time to Compare Skin-to-Skin Time for Conventional Versus TruMatch® Primary Total Knee Replacements — 65.8; 67.3 minutes — p=0.54
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Surgical Procedure Time to Compare Skin-to-Skin Time for Conventional Versus TruMatch® Primary Total Knee Replacements |
65.8; 67.3 | 0.54 |
| SECONDARY Operating Room Setup - Operating Room Cleaned up From Previous Case to Surgical Draping Complete |
28.9; 28.8 | — |
| SECONDARY Turnover Time (Time to Clean Operating Room After Surgery is Completed) |
10.1; 11.4 | — |
| SECONDARY Costs Associated With Conventional Versus TruMatch® Total Knee Arthroplasty Surgical Procedures |
— | — |
| SECONDARY To Compare the Differences in Operating Room Efficiency as a Function of Institution Type and Geographical Location |
— | — |
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).
Data sourced from ClinicalTrials.gov (NCT01301950). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.