TKA Operating Room Efficiency for TKA Using Customized Implant Techniques

Osteoarthritis, Knee Clinical Trial

Official title:

What Factors Affect Operating Room Efficiency When Performing TKA Using Customized Implant Techniques: Conformis iTotal (CR), (PS)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04180423
• Other study ID #: 19-002i
• Status: Terminated
• Start date: January 28, 2020
• Est. completion date: September 19, 2022

Study information

• Verified date: October 2023
• Source: Restor3D
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 59
• Est. completion date: September 19, 2022
• Est. primary completion date: September 19, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Device:
• Off-the-Shelf Implant Total Knee Replacement
Total Knee Replacement, or knee arthroplasty, is a common surgical procedure performed to relieve the pain and disability resulting from osteoarthritis. In general, the surgery consists of replacing the diseased or damaged joint surfaces of the knee with metal and plastic components shaped to allow continued motion of the knee. Off-the-Shelf implants use standard sizing.
• Customized Implant Total Knee Replacement
Total Knee Replacement, or knee arthroplasty, is a common surgical procedure performed to relieve the pain and disability resulting from osteoarthritis. In general, the surgery consists of replacing the diseased or damaged joint surfaces of the knee with metal and plastic components shaped to allow continued motion of the knee. Customized implants are customized individually made knee implants which are designed specific to each patient's unique anatomy.

Locations

Country	Name	City	State
United States	Kettering Medical Center	Kettering	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Restor3D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operating Room Efficiency	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	Single time point - day of surgery