Clinical Outcomes of Joint Arthroplasty

Osteoarthritis, Knee Clinical Trial

Official title:

Clinical Outcomes of Joint Arthroplasty

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03668691
• Other study ID #: 002
• Status: Active, not recruiting
• Start date: July 2011
• Est. completion date: March 2027

Study information

• Verified date: September 2018
• Source: St. Helena Hospital Coon Joint Replacement Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	St. Helena Hospital Coon Joint Replacement Institute	Saint Helena	California

Sponsors (2)

Lead Sponsor	Collaborator
St. Helena Hospital Coon Joint Replacement Institute	Stryker Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of patients with Revisions	To assess the revision rate of this patient population	10 years after surgery
Secondary	Patient satisfaction rate	To assess level of patient satisfaction using a questionnaire.	10 years after surgery