Clinical Outcomes of Joint Arthroplasty

Active, not recruiting

• Conditions: Osteoarthritis, Knee

• Registration Number: NCT03668691
• Lead Sponsor: St. Helena Hospital Coon Joint Replacement Institute

Brief Summary

The purpose of this study is to document the clinical outcomes of partial knee replacement surgery using robotic-arm assisted knee joint surgery at 3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post operative.

Detailed Description

The purpose of this study is to document the clinical outcomes of partial knee replacement surgery using robotic-arm assisted knee joint surgery at 3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post operative.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2016-09-28
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-10
• Last Update Submitted: 2018-09-10
• Study First Posted: 2018-09-12
• Last Update Posted: 2018-09-12
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• All patients over 21 years of age who require a primary robotic-arm assisted unicompartmental knee arthroplasty or bicompartmental knee arthroplasty. These patients will have failed non-operative management of their joint disease and are candidates for partial joint replacement because of pain and stiffness that interferes with their performances or normal daily activities.

Exclusion Criteria

• Patient had an active infection
• Onlay implants were implanted without bone cement
• Patient does not have enough bone stock to allow for insertion and fixation of the components
• Patient does not have sufficient soft tissue integrity to allow for stability
• Patient has a neurological or muscular deformity that did not allow for control of the knee
• Patient will be excluded from participation in the study if they are cognitively unable to answer study questions
• Pregnant women are excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
% of patients with Revisions	10 years after surgery	To assess the revision rate of this patient population

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction rate	10 years after surgery	To assess level of patient satisfaction using a questionnaire.

Trial Locations

Locations (1)

St. Helena Hospital Coon Joint Replacement Institute; 🇺🇸 Saint Helena, California, United States