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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03668717
Enrollment
133
Registered
2018-09-13
Start date
2011-10-31
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, unicompartmental

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.

Interventions

DEVICERobotic-arm assisted medical MCK implant

Robotic-arm assisted medical MCK implant system to replace the medial compartment of the knee.

Sponsors

Stryker Orthopaedics
CollaboratorINDUSTRY
St. Helena Hospital Coon Joint Replacement Institute
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
% of patients with revisions10 year after surgeryTo determine the revision rate in this patient population

Secondary

MeasureTime frameDescription
% of patients with revisions2 years after surgeryTo determine the revision rate in this patient population

Other

MeasureTime frameDescription
% of patients with revisions5 years after surgeryTo determine the revision rate in this patient popluation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026