Clinical Outcomes of Joint Arthroplasty

Northwest Surgical Specialists, Vancouver1 site in 1 country316 target enrollmentOctober 2012

ConditionsKnee Arthroplasty

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Knee Arthroplasty
Sponsor: Northwest Surgical Specialists, Vancouver
Enrollment: 316
Locations: 1
Primary Endpoint: Survivorship of Components
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

September 19, 2018

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Northwest Surgical Specialists, Vancouver

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Survivorship of Components

Time Frame: 10 years

Survivorship of components is defined as knee implant device(s) remaining in patient.

Secondary Outcomes

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)