Clinical Outcomes of Knee Replacement

Northwest Surgical Specialists, Vancouver

Status: Terminated

Conditions: Knee Arthroplasty

Treatments: Procedure: MAKO® Robot Assisted Medial Knee Arthroplasty; Procedure: MAKO® Robot Assisted Medial and PF Knee Arthroplasty; Procedure: Non-MAKO® Robot Assisted Total Knee Arthroplasty; Device: Stryker® Knee Replacement System; Device: RESTORIS Multicompartmental Knee System; Device: Depuy Knee Replacement System

Study type: Observational

Funder types: Other

Identifiers

NCT01705366

Borus 2015-005 (Other Identifier)

MAKO-01

Details and patient eligibility

About

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.

Enrollment: 316 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• requires either primary or revision knee replacement surgery because of pain and joint stiffness that interferes with performance of normal daily activities
• has failed non-operative management of their joint disease

Exclusion criteria

• cognitively unable to complete study health-related quality of life forms
• pregnant women

Trial design

316 participants in 1 patient group

Knee Arthroplasty

Description:

Patients undergoing total knee arthroplasty. This may be Non-MAKO® Robot Assisted Total Knee Arthroplasty or MAKO® Robot Assisted Medial Knee Arthroplasty or MAKO® Robot Assisted Medial and PF Knee Arthroplasty The Non-MAKO® Robot Assisted Total Knee Arthroplasty uses the Depuy Knee Replacement System or the Stryker® Knee Replacement System. The MAKO® Robot Assisted Arthroplasty uses the RESTORIS Multicompartmental Knee System .

Treatment:

Device: Stryker® Knee Replacement System

Device: Depuy Knee Replacement System

Device: RESTORIS Multicompartmental Knee System

Procedure: Non-MAKO® Robot Assisted Total Knee Arthroplasty

Procedure: MAKO® Robot Assisted Medial and PF Knee Arthroplasty

Procedure: MAKO® Robot Assisted Medial Knee Arthroplasty