Trials / Terminated
TerminatedNCT04180423
TKA Operating Room Efficiency for TKA Using Customized Implant Techniques
What Factors Affect Operating Room Efficiency When Performing TKA Using Customized Implant Techniques: Conformis iTotal (CR), (PS)
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 59 (actual)
- Sponsor
- Restor3D · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| DEVICE | 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. |
Timeline
- Start date
- 2020-01-28
- Primary completion
- 2022-09-19
- Completion
- 2022-09-19
- First posted
- 2019-11-27
- Last updated
- 2023-10-25
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04180423. Inclusion in this directory is not an endorsement.