A Comparative Study of Knee Systems (Bake-Off)

Foundation for Southwest Orthopedic Research

Status and phase

Completed

Phase 4

Conditions

Osteoarthritis of the Knee

Treatments

Procedure: Total Knee Arthroplasty with Custom Cutting Blocks

Procedure: Total Knee Arthroplasty via Computer Assisted Surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT01331278

0509-0060

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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