Survivorship and Outcomes of Robotic-Arm Assisted Bicompartmental Arthroplasty

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03668704

Enrollment

Registered

2018-09-13

Start date

2013-04-30

Completion date

2026-04-30

Last updated

2018-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

osteoarthritis, medial, bicompartmental, patellofemoral

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
% of patients with Revisions	10 years after surgery	To determine the revision rate in this patient population

Secondary

Measure	Time frame	Description
% of patients with Revisions	2 years after surgery	To determine the revision rate in this patient population

Other

Measure	Time frame	Description
% of patients with revisions	5 years after surgery	To determine the revision rate in this patient population

Countries

United States

Outcome results