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Clinical Outcomes of Joint Arthroplasty

Clinical Outcomes of Joint Arthroplasty

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03668691
Enrollment
250
Registered
2018-09-12
Start date
2011-07-31
Completion date
2027-03-31
Last updated
2018-09-12

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

Conditions

Osteoarthritis, Knee

Keywords

osteoarthritis, medial unicompartmental, lateral unicompartmental, bicompartmental, patellofemoral

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.

Interventions

DEVICERobotic-arm assisted partial knee arthroplasty

Robotic-arm assisted medial unicompartmental knee arthroplasty, lateral unicompartmental knee arthroplasty, bicompartmental knee arthroplasty, patellofemoral knee arthroplasty implants. A robotic arm assisted unicompartmental or bicompartmental knee arthroplasty procedure to replace the medial or lateral and /or patellofemoral compartments of the knee.

Sponsors

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

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

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

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.

Design outcomes

Primary

MeasureTime frameDescription
% of patients with Revisions10 years after surgeryTo assess the revision rate of this patient population

Secondary

MeasureTime frameDescription
Patient satisfaction rate10 years after surgeryTo assess level of patient satisfaction using a questionnaire.

Countries

United States

Outcome results

None listed

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