Trials / Terminated
TerminatedNCT01705366
Clinical Outcomes of Knee Replacement
Clinical Outcomes of Joint Arthroplasty
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 316 (actual)
- Sponsor
- Northwest Surgical Specialists, Vancouver · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to document the demographic and clinical characteristics and the long-term clinical outcomes of patients who require a robot assisted knee arthroplasty. The hypothesis is that MAKO® robot assisted surgery replacing one or two compartments of the knee joint has 10 year implant survival and clinical outcomes that are equivalent to other knee replacement systems.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Non-MAKO® Robot Assisted Total Knee Arthroplasty | Patients undergoing a non-MAKO® robot assisted surgery to replace one or more compartments of the knee. |
| PROCEDURE | MAKO® Robot Assisted Medial Knee Arthroplasty | Patients undergoing a MAKO® robot assisted surgery to replace the medial compartment of the knee. |
| PROCEDURE | MAKO® Robot Assisted Medial and PF Knee Arthroplasty | Patients undergoing a MAKO® robot assisted surgery to replace the medial and patellofemoral (PF) compartments of the knee |
| DEVICE | RESTORIS Multicompartmental Knee System | The RESTORIS Multicompartmental Knee (MCK) System components are intended for single or multicompartmental knee replacement used in conjunction with the MAKO® Robotic Arm Interactive Orthopedic System (RIO®). The components can be used for medial compartment, lateral compartment, patellofemoral compartment, or bicompartmental (medial and patellofemoral compartments) knee replacement. The device is intended to be used with bone cement. |
| DEVICE | Depuy Knee Replacement System | The Depuy Knee Replacement System components are intended for use in total knee replacement. These components are intended for implantation with bone cement. |
| DEVICE | Stryker® Knee Replacement System | The Stryker® Knee Replacement System components are intended for use in total knee replacement. These components are intended for implantation with bone cement. |
Timeline
- Start date
- 2012-10-01
- Primary completion
- 2018-09-19
- Completion
- 2018-09-19
- First posted
- 2012-10-12
- Last updated
- 2018-09-26
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01705366. Inclusion in this directory is not an endorsement.