TKA Operating Room Efficiency for TKA Using Customized Implant Techniques

restor3d

Status: Terminated

Conditions: Osteoarthritis, Knee

Treatments: Device: Off-the-Shelf Implant Total Knee Replacement; Device: Customized Implant Total Knee Replacement

Study type: Observational

Funder types: Industry

Identifiers

NCT04180423

19-002i

Details and patient eligibility

About

This is a multi-centered prospective, consecutively enrolled study that will be conducted in the United States. Surgeons that are new users of the iTotal Knee system (defined by no experience using the customized Total Knee Replacement (TKR) in the last 6 months) will be involved in the study. To complete the study protocol, the center will collect baseline surgical and training data on 10 "off-the-shelf" TKR patients using the implant system the surgeon currently uses. Then the first 50 consecutive patients who have been identified to receive the iTotal implant (Cruciate-Retaining or Posterior-Stabilizing) based on patient factors and the implant system IFU will be enrolled in the study. Simultaneous bilateral Total Knee Arthroplasty cases will be excluded.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• > 18 years of age

Exclusion criteria

• Participation in another clinical study which would confound results
• Inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons
• Simultaneous bilateral Total Knee Arthroplasty cases

Trial design

59 participants in 2 patient groups

Off-the-Shelf Total Knee Arthroplasty Patients

Treatment:

Device: Off-the-Shelf Implant Total Knee Replacement

Conformis iTotal Total Knee Arthroplasty Patients

Treatment:

Device: Customized Implant Total Knee Replacement