Trials / Terminated
TerminatedNCT01820650
A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 359 (actual)
- Sponsor
- Restor3D · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to observe the long term clinical outcomes of patient-specific knee arthroplasty in patients with osteoarthritis.
Detailed description
If the patient has previously received a standard total knee replacement in their contralateral knee, the primary endpoint questionnaire and some secondary endpoint questionnaires will be completed regarding BOTH their iTotal® CR knee and their standard total knee for all time points where questionnaires are required by the protocol.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | iTotal G2 CR Knee Replacement System | Total Knee replacement |
Timeline
- Start date
- 2013-02-01
- Primary completion
- 2017-03-01
- Completion
- 2023-10-01
- First posted
- 2013-03-29
- Last updated
- 2023-10-25
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT01820650. Inclusion in this directory is not an endorsement.