Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT01301950
First received: December 2, 2010
Last updated: February 10, 2014
Last verified: February 2014

December 2, 2010
February 10, 2014
May 2010
June 2013   (final data collection date for primary outcome measure)
Surgical procedure time to compare skin-to-skin time for conventional versus TruMatch primary Total Knee Replacements [ Time Frame: This study compares the use of two different intruments used during the surgical procedure and thus the time frame of the study is during the procedure, while the patient is in the operating room. ] [ Designated as safety issue: No ]
It is anticipated that there will be large within and between site differences in surgical skin to skin time using the two surgical instruments. Therefore,a 2-way analysis of variance (ANOVA) model that contains 'treatment', 'site', and a 'treatment*site' interaction term that adjust for these differences using type III sums of squares will be the statistical test utilized to determine if surgical skin to skin time differences are indicated.
Same as current
Complete list of historical versions of study NCT01301950 on ClinicalTrials.gov Archive Site
  • To compare substeps of the primary versus TruMatch TKA surgical procedures including OR set-up and turnover time [ Time Frame: This study compares the use of two different intruments used during the surgical procedure and thus the time frame of the study is during the procedure, while the patient is in the operating room. ] [ Designated as safety issue: No ]
  • To compare the costs associated with conventional versus TruMatch TKA surgical procedures [ Time Frame: This study compares the use of two different intruments used during the surgical procedure and thus the time frame of the study is during the procedure, while the patient is in the operating room. ] [ Designated as safety issue: No ]
  • To compare the differences in OR efficiency as a function of institution type and geographic location [ Time Frame: This study compares the use of two different intruments used during the surgical procedure and thus the time frame of the study is during the procedure, while the patient is in the operating room. ] [ Designated as safety issue: No ]
  • To compare the rate and type of intraoperative adverse events [ Time Frame: This study compares the use of two different intruments used during the surgical procedure and thus the time frame of the study is during the procedure, while the patient is in the operating room. ] [ Designated as safety issue: Yes ]
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Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty
Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty Using TruMatch Personalized Solutions Compared to Conventional Total Knee Arthroplasty

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.

The study is designed as a prospective, multi-center, non-randomized, clinical investigation to determine whether TruMatch™ alignment is non-inferior to alignment achieved in a recently completed study (historical control) with conventional instrumentation.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Males and females who are appropriate candidates for primary knee replacement between the ages of 18 and 80 years, inclusive, with non-inflammatory degenerative joint disease will be considered for this investigation.

Osteoarthritis, Knee
Other: Instrument
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
Other Name: TruMatch™ Personalized Solutions
  • TruMatch™ Personalized Solutions
    Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions
    Intervention: Other: Instrument
  • Conventional Total Knee Replacement
    Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
June 2013
June 2013   (final data collection date for primary outcome measure)

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 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).
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01301950
08004
No
DePuy Orthopaedics
DePuy Orthopaedics
Not Provided
Principal Investigator: Carl Painter Pinnacle Orthopaedics
DePuy Orthopaedics
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP