Survivorship and Outcomes of Robotic-Arm Assisted Medial Unicompartmental Knee Arthroplasty

Active, not recruiting

• Conditions: Osteoarthritis

• Registration Number: NCT03668717
• Lead Sponsor: St. Helena Hospital Coon Joint Replacement Institute

Brief Summary

The purpose of the study is to determine the survivorship of robotic-arm assisted MCK medial onlay Unicompartmental knee arthroplasty implants at two, five and tem year follow up.

Detailed Description

The purpose of the study is to determine the survivorship of robotic-arm assisted MCK medial onlay unicompartmental knee arthroplasty implants at two, five, and ten year follow up. Study participants will also be asked about their level of satisfaction with their knee function following their robotic-arm assisted Unicompartmental Arthroplasty.

Study Timeline

• Study Start: 2011-10
• 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: 2018-09-13
• Last Update Posted: 2018-09-13
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 133

Inclusion Criteria

• All patients over 21 years of age who underwent primary robotic-arm assisted unicompartmental arthroplasty and received a medial MCK onlay implant and are at least 24 months post-operative.
• Patient has signed an IRB approved Informed Consent Form or with IRB approved waiver of written consent, patient has verbally consented to study participations.
• Patient willing to comply with follow up.

Exclusion Criteria

• Patient will be excluded from participation in the study if they are cognitively unable to answer questions related to their index procedure and health related quality of life forms.
• Patient had active infection
• Medial MCK onlay implants were implanted without bone cement
• Patients did not have sufficient bone stock to allow for insertion and fixation of components
• Patient did not have sufficient soft tissue integrity to allow for stability
• Patient had a neurological or muscular deformity that did not allow for control of the knee.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
% of patients with revisions	10 year after surgery	To determine the revision rate in this patient population

Secondary Outcome Measures

Name	Time	Method
% of patients with revisions	2 years after surgery	To determine the revision rate in this patient population

Trial Locations

Locations (1)

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