TKA Operating Room Efficiency for TKA Using Customized Implant Techniques

NCT04180423 | Terminated FDA Device

• 1 other identifier: 19-002i
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Off-the-Shelf Total Knee Arthroplasty Patients

Device: Off-the-Shelf Implant Total Knee Replacement

Conformis iTotal Total Knee Arthroplasty Patients

Device: Customized Implant Total Knee Replacement

Interventions

Off-the-Shelf Implant Total Knee Replacement DEVICE

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.

Off-the-Shelf Total Knee Arthroplasty Patients

Customized Implant Total Knee Replacement DEVICE

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.

Also known as: Conformis iTotal

Conformis iTotal Total Knee Arthroplasty Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients receiving Total Knee Arthroplasty

You may qualify if:

• \> 18 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Restor3D: lead

Study Sites (1)

Kettering Medical Center

Kettering, Ohio, 45429, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: November 27, 2019
• Study Start: January 28, 2020
• Primary Completion: September 19, 2022
• Study Completion: September 19, 2022
• Last Updated: October 25, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)