Survivorship and Outcomes of Robotic-Arm Assisted Bicompartmental Arthroplasty

NCT ID: NCT03668704

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

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2026-04-30

Brief Summary

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The purpose of the study is to determine the clinical outcomes and survivorship of robotic-arm assisted medial bicompartmental knee arthroplasty at two, five, seven and ten years postoperative.

Detailed Description

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The purpose of the study is to determine the survivorship, patient satisfaction and clinical outcomes of robotic-arm assisted medial bicompartmental knee arthroplasty using the MCK implant system starting at two years post-operative and continuing for five, seven and ten years post-operative.

Conditions

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Osteoarthritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Medial Bicompartmental Knee Arthroplasty

Patient who have received a robotic-arm assisted medial and patellofemoral knee arthroplasty.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* All patients over 21 years of age who underwent robotic-arm assisted medial bicompartmental arthroplasty by the investigating surgeon and received MCK implants and are at least 24 months post-operative.
* Patient has signed an IRB approved Informed Consent Form or with IRB approved waiver of written signed consent, patient has verbally consented to study participation.
* Patient is willing to comply with follow up

Exclusion Criteria

* Patients will be excluded from participation in the study if they are cognitively unable to answer questions related to their index procedure and health quality of life forms.
* Patient had active infection
* 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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003

Identifier Type: -

Identifier Source: org_study_id

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