Clinical Outcomes of Joint Arthroplasty

NCT03668691 | Active Not Recruiting

• 1 other identifier: 002
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

osteoarthritis; medial unicompartmental; lateral unicompartmental; bicompartmental; patellofemoral

Outcome Measures

Primary Outcomes (1)

• % of patients with Revisions

  To assess the revision rate of this patient population

  10 years after surgery

Secondary Outcomes (1)

• Patient satisfaction rate

  10 years after surgery

Interventions

Robotic-arm assisted partial knee arthroplasty DEVICE

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.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients over 21 years of age who require a primary robotic-arm assisted partial knee replacement.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Helena Hospital Coon Joint Replacement Institute: lead
• Stryker Orthopaedics: collaborator

Study Sites (1)

St. Helena Hospital Coon Joint Replacement Institute

St. Helena, California, 94574, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Thomas Coon, MD

  St. Helena Hospital Coon Joint Replacement Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: September 12, 2018
• Study Start: July 1, 2011
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 12, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)