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

NCT ID: NCT03668717

Last Updated: 2018-09-13

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

133 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2026-04-30

Brief Summary

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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

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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.

Conditions

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Osteoarthritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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Robotic-arm assisted medical MCK implant

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

Intervention Type DEVICE

Eligibility Criteria

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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.
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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004

Identifier Type: -

Identifier Source: org_study_id

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