TKA Operating Room Efficiency for TKA Using Customized Implant Techniques

Terminated

• Conditions: Osteoarthritis, Knee
• Interventions: Device: Off-the-Shelf Implant Total Knee Replacement; Device: Customized Implant Total Knee Replacement

• Registration Number: NCT04180423
• Lead Sponsor: Restor3D

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-25
• Study First Submitted QC: 2019-11-26
• Study First Posted: 2019-11-27
• Study Start: 2020-01-28
• Primary Completion: 2022-09-19
• Study Completion: 2022-09-19
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Off-the-Shelf Total Knee Arthroplasty Patients	Off-the-Shelf Implant Total Knee Replacement	-
Conformis iTotal Total Knee Arthroplasty Patients	Customized Implant Total Knee Replacement	-

Primary Outcome Measures

Name	Time	Method
Operating Room Efficiency	Single time point - day of surgery	Surgeon questionnaire to determine operating room efficiency from the 1st to the 50th iTotal implant performed and to determine any differences that might exist between operating room efficiency between the iTotal surgery and baseline metrics when performing OTS implant surgery

Trial Locations

Locations (1)

Kettering Medical Center; 🇺🇸 Kettering, Ohio, United States