Survivorship and Outcomes of Robotic-Arm Assisted Bicompartmental Arthroplasty

Active, not recruiting

• Conditions: Osteoarthritis

• Registration Number: NCT03668704
• Lead Sponsor: St. Helena Hospital Coon Joint Replacement Institute

Brief Summary

The purpose of the study is to determine the clinical outcomes and survivorship of robotic-arm assisted medial bicompartmental knee arthroplasty at two, five, seven and ten years postoperative.

Detailed Description

The purpose of the study is to determine the survivorship, patient satisfaction and clinical outcomes of robotic-arm assisted medial bicompartmental knee arthroplasty using the MCK implant system starting at two years post-operative and continuing for five, seven and ten years post-operative.

Study Timeline

• Study Start: 2013-04
• 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: 50

Inclusion Criteria

• All patients over 21 years of age who underwent robotic-arm assisted medial bicompartmental arthroplasty by the investigating surgeon and received MCK implants and are at least 24 months post-operative.
• Patient has signed an IRB approved Informed Consent Form or with IRB approved waiver of written signed consent, patient has verbally consented to study participation.
• Patient is willing to comply with follow up

Exclusion Criteria

• Patients will be excluded from participation in the study if they are cognitively unable to answer questions related to their index procedure and health quality of life forms.
• Patient had active infection
• 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 years 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