A Comparative Study of Knee Systems (Bake-Off)

This study has been completed.
Sponsor:
Information provided by:
Foundation for Southwest Orthopedic Research
ClinicalTrials.gov Identifier:
NCT01331278
First received: April 6, 2011
Last updated: April 7, 2011
Last verified: April 2011
  Purpose

The custom cutting guides personalized for each patient via pre-operative MRI will result in significantly faster intraoperative time with comparable knee alignment accuracy, cost, knee function, and patient satisfaction.


Condition Intervention Phase
Osteoarthritis of the Knee
Procedure: Total Knee Arthroplasty with Custom Cutting Blocks
Procedure: Total Knee Arthroplasty via Computer Assisted Surgery
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparative Study of Knee Systems Employing Personalized Computer Generated Cutting Guides for Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Foundation for Southwest Orthopedic Research:

Primary Outcome Measures:
  • mean intraoperative time [ Time Frame: measured during surgery (day 1) ] [ Designated as safety issue: No ]
    Time measured in pre-defined segments from the point that the patient is wheeled into the OR until the OR is clean and ready for the next case's activities to begin.


Secondary Outcome Measures:
  • alignment accuracy [ Time Frame: 3 weeks post-op ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: September 2009
Study Completion Date: March 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Custom Cutting Blocks Procedure: Total Knee Arthroplasty with Custom Cutting Blocks
Subjects randomized to this study group will undergo TKA with patient specific custom cutting blocks generated by pre-op MRI and a Biomet Vanguard knee implant
Other Name: Signature Knee System
Active Comparator: Computer Assisted Surgery Procedure: Total Knee Arthroplasty via Computer Assisted Surgery
Subjects randomized to this study group will receive TKA via computer assisted surgery and a Biomet Vanguard knee implant

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • must be scheduled to undergo TKA with no bilateral TKA planned within 6 weeks of the initial surgery date
  • must be 18 years of age or older
  • must be capable and willing to provide informed consent
  • must have flexion contracture less than 15 degrees.
  • must have ligament stability no more than 2 degrees instability in varus/valgus extension stress

Exclusion Criteria:

  • medical condition or personal circumstances that will prevent participation and completion of the follow-up visits at 3 weeks, 6 weeks and 3 months post-op
  • currently participating in or has participated in (within 30 days prior to inclusion in this study) another clinical trial of an investigational drug, biologic, device, or procedure
  • known pre-operative systemic infections, uncontrolled diabetes, or diseases or conditions that are known to interfere with the wound healing process
  • Knee alignment deformities greater than 7 degrees varus or valgus
  • known prior knee revisions or previous surgeries deemed to compromise the TKA incision exposure
  • known medical conditions prohibiting the use of MRI or nickel allergy, sensitivity, or hardware in the region of the knee
  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: NCT01331278

Locations
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
Southwest Orthopedic Group, LLP
Houston, Texas, United States, 77030
Sponsors and Collaborators
Foundation for Southwest Orthopedic Research
  More Information

No publications provided

Responsible Party: David R. Lionberger, MD, Southwest Orthopedic Group, LLP
ClinicalTrials.gov Identifier: NCT01331278     History of Changes
Other Study ID Numbers: 0509-0060
Study First Received: April 6, 2011
Last Updated: April 7, 2011
Health Authority: United States: The Methodist Hospital research Institute Institutional Review Board
United States: Institutional Review Board

Keywords provided by Foundation for Southwest Orthopedic Research:
total joint replacement
knee

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

ClinicalTrials.gov processed this record on October 19, 2014