MedPath

Clinical Outcomes of Knee Replacement

Terminated
Conditions
Knee Arthroplasty
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

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
Primary Outcome Measures
NameTimeMethod
Survivorship of Components10 years

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

Secondary Outcome Measures
NameTimeMethod
American Knee Society Knee Score1-2 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

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

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