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
  Purpose

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.


Condition Intervention
Osteoarthritis, Knee
Other: Instrument

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty Using TruMatch Personalized Solutions Compared to Conventional Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by DePuy Orthopaedics:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 29
Study Start Date: May 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
TruMatch™ Personalized Solutions
Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions
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
Conventional Total Knee Replacement
Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

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 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01301950

Locations
United States, Indiana
Center for Hip and Knee Surgery
Mooresville, Indiana, United States, 46158
United States, Oklahoma
Pinnacle Orthopaedics
Bartlesville, Oklahoma, United States, 74006
United States, Virginia
Commonwealth Orthopaedics
Reston, Virginia, United States, 20190
Sponsors and Collaborators
DePuy Orthopaedics
Investigators
Principal Investigator: Carl Painter Pinnacle Orthopaedics
  More Information

No publications provided

Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT01301950     History of Changes
Other Study ID Numbers: 08004
Study First Received: December 2, 2010
Last Updated: February 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by DePuy Orthopaedics:
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

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 23, 2014