Trials / Terminated
TerminatedNCT04667559
A Study to Evaluate the Conformis iTotal Identity Knee Replacement System
A Prospective, Multicenter Study to Evaluate the Conformis iTotal Identity Knee Replacement System
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 22 (actual)
- Sponsor
- Restor3D · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
This is a prospective multicenter study located in the United States. Subjects will be implanted with an iTotal Identity Knee Replacement System and followed for 10 years post implantation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Conformis iTotal Identity Knee Replacement System | The iTotal® Identity KRS is a tri-compartmental semi-constrained knee prosthesis composed of three components: a Femoral Component, a Tibial Component, and a Patellar Component.Using patient imaging, a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The treatment allows for the placement of a cemented metallic device designed from the patient's natural bone geometry. This process allows definition of the shape and size of the femoral and tibial components of the implant, as well as the disposable instrumentation. |
Timeline
- Start date
- 2020-10-12
- Primary completion
- 2022-12-14
- Completion
- 2022-12-14
- First posted
- 2020-12-14
- Last updated
- 2023-10-25
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04667559. Inclusion in this directory is not an endorsement.