Clinical Outcomes of Knee Replacement

Terminated

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

• Registration Number: NCT01705366
• Lead Sponsor: Northwest Surgical Specialists, Vancouver

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-09
• Study First Submitted QC: 2012-10-09
• Study First Posted: 2012-10-12
• Status Verified: 2018-09
• Primary Completion: 2018-09-19
• Study Completion: 2018-09-19
• Last Update Submitted: 2018-09-24
• Last Update Posted: 2018-09-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 316

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Knee Arthroplasty	Depuy Knee Replacement System	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 .
Knee Arthroplasty	Stryker® Knee Replacement System	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 .
Knee Arthroplasty	MAKO® Robot Assisted Medial and PF Knee Arthroplasty	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 .
Knee Arthroplasty	RESTORIS Multicompartmental Knee System	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 .
Knee Arthroplasty	Non-MAKO® Robot Assisted Total Knee Arthroplasty	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 .
Knee Arthroplasty	MAKO® Robot Assisted Medial Knee Arthroplasty	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 .

Primary Outcome Measures

Name	Time	Method
Survivorship of Components	10 years	Survivorship of components is defined as knee implant device(s) remaining in patient.

Secondary Outcome Measures

Name	Time	Method
American Knee Society Knee Score	1-2 weeks prior to surgery, 1-2 weeks after surgery, 4-6 weeks after surgery, 10-12 weeks after surgery, 6 months after surgery, 1 year, 2 years, 5 years, and 10 years after surgery	The American Knee Society Score is an assessment and questionnaire that provides a rating of the pain, function, range of motion, and knee joint stability. It is subdivided into a knee score that rates only the knee joint itself and a functional score that rates the patient's ability to walk and climb stairs.

Trial Locations

Locations (1)

Rebound Orthopedics and Neurosurgery; 🇺🇸 Vancouver, Washington, United States