Clinical Outcomes of Joint Arthroplasty

NCT ID: NCT03668691

Last Updated: 2018-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2027-03-31

Brief Summary

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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

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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

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Osteoarthritis, Knee

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Robotic-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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stryker Orthopaedics

INDUSTRY

Sponsor Role collaborator

St. Helena Hospital Coon Joint Replacement Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Coon, MD

Role: PRINCIPAL_INVESTIGATOR

St. Helena Hospital Coon Joint Replacement Institute

Locations

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St. Helena Hospital Coon Joint Replacement Institute

St. Helena, California, United States

Site Status

Countries

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United States

Other Identifiers

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002

Identifier Type: -

Identifier Source: org_study_id

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