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Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty Using TruMatch Personalized Solutions Compared to Conventional Total Knee Arthroplasty
This study is currently Recruiting
September 2011 By DePuy Orthopaedics
First Recieved on December 2, 2010
Last Updated on September 30, 2011
This study is designed to compare the surgical efficiency of TruMatch? Personalized
Solutions surgical technique compared to conventional (manual instruments) surgical
technique. Specifically, the purpose of this study is to collect time data to enhance the
existing economic model.
||Observational Model: Case Control, Time Perspective: Prospective
Resources/Links provided by NLM:
|Study Start Date:
|Estimated Primary Completion Date:
|TruMatch? Personalized Solutions:|
Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch? Personalized Solutions
|Conventional Total Knee Replacement:|
Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
TruMatch? Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. 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
|Ages Eligible for Study:||18 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
- 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
- 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 are consistent with TruMatch? instrumentation.
- 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
- The Subject requires simultaneous bilateral total knee replacements.
- The Subject had a contralateral TKA and that knee was previously entered in the
- 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).
- Investigator: Carl Painter - Principal Investigator - Pinnacle Orthopaedics
- Pinnacle Orthopaedics
Bartlesville, Oklahoma 74006 United States
- Commonwealth Orthopaedics
Reston, Virginia 20190 United States