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OpenTrials
Active, not recruiting

NCT Number: NCT03668691

Clinical Outcomes of Joint Arthroplasty

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Helena Hospital Coon Joint Replacement Institute

St. Helena, California, 94574, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. % of patients with Revisions

    Time frame: 10 years after surgery

    To assess the revision rate of this patient population

Secondary outcomes

  1. Patient satisfaction rate

    Time frame: 10 years after surgery

    To assess level of patient satisfaction using a questionnaire.

Sponsors and collaborators

Lead sponsor

St. Helena Hospital Coon Joint Replacement Institute

Other

Collaborators

  • Stryker Orthopaedics

Registry information

Important dates

Study start
2011
Primary completion
2027
Study completion
2027
First posted
Sep 12, 2018
Registry last updated
Sep 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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