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Completed

NCT Number: NCT01331278

A Comparative Study of Knee Systems

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.

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Southwest Orthopedic Group, LLP, Houston, Texas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total Knee Arthroplasty with Custom Cutting Blocks

Procedure

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 names: Signature Knee System

Total Knee Arthroplasty via Computer Assisted Surgery

Procedure

Subjects randomized to this study group will receive TKA via computer assisted surgery and a Biomet Vanguard knee implant

Primary outcomes

  1. mean intraoperative time

    Time frame: measured during surgery (day 1)

    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 outcomes

  1. alignment accuracy

    Time frame: 3 weeks post-op

Sponsors and collaborators

Lead sponsor

Foundation for Southwest Orthopedic Research

Other

Registry information

Official study title

A Comparative Study of Knee Systems Employing Personalized Computer Generated Cutting Guides for Total Knee Arthroplasty

Acronym: Bake-Off

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Apr 8, 2011
Registry last updated
Apr 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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