Fixed Bearing Versus Mobile Bearing Patient Satisfaction and Clinical Outcome Study

Withdrawn

• Conditions: Osteoarthritis
• Interventions: Device: Fixed Bearing or Mobile Bearing UKA

• Registration Number: NCT02633085
• Lead Sponsor: Medacta USA

Brief Summary

The purpose of this study is to determine if there is a patient satisfaction preference of Fixed Bearing versus Mobile Bearing Unicompartmental Knee Arthroplasty (UKA) in patients who are at a minimum two years post operative. Patient reported outcomes and expectations will be analyzed along with all retrospective chart data in patient with a Fixed Bearing or a Mobile Bearing UKA in one or both knees.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-15
• Study First Submitted QC: 2015-12-16
• Study First Posted: 2015-12-17
• Study Start: 2016-02
• Status Verified: 2023-03
• Primary Completion: 2023-03-22
• Study Completion: 2023-03-22
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF)
2. Ability to understand and provide written authorization for use and disclosure of personal health information.
3. Subject who are able and willing to comply with the study protocol and follow-up visit.
4. Must be 18 years or older to participate.
5. Subjects must have a clinically documented Osteoarthritis in a knee, single or multiple compartments,
6. Subjects must have undergone a FB UKA or MB UKA in one and or both knees. MB UKA or FB UKA patients revised to Total Knee Arthroplasty (TKA) are eligible to enroll.
7. Must be a minimum 2 year (24 months) post-surgery on the knee.
8. The UKA operation must have been performed by the Investigator.
9. Subjects must be able to return for the follow-up appointment, and have the mental capacity to cooperate with PRO's, questionnaires, physical exam and imaging studies.

Exclusion Criteria

1. Subjects with Bicompartmental UKA (i.e. medical or lateral UKA combined with Patello Femoral Joint (PFJ) (UKA)
2. Women who are pregnant.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fixed Bearing or Mobile Bearing UKA	Fixed Bearing or Mobile Bearing UKA	-

Primary Outcome Measures

Name	Time	Method
To compare patient satisfaction scores of the Unicompartmental Fixed Bearing (FB) UKA vs Unicompartmental Mobile Bearing (MB) UKA	Minimum of two years post-surgery.	Utilizing Knee Score Society survey sub-score

Secondary Outcome Measures

Name	Time	Method
Complications	Minimum of two years post-surgery.	Complications will be recorded
Knee Injury and Osteoarthritis Outcome Score (KOOS)	Minimum of two years post-surgery.	Knee symptoms, pain, function and Qol
Forgotten Joint Score (FJS)	Minimum of two years post-surgery.	Knee Function-patients ability to forget the artificial joint in everyday life
Euro-Qual Health related Quality of Life	Minimum of two years post-surgery.	General Health Status
Demographics	Minimum of two years post-surgery.
Return to Work History	Minimum of two years post-surgery.	Questionnaire for work history prior to surgery and after surgery
Knee Society Score (KSS) subjective measures	Minimum of two years post-surgery.	patient expectation and satisfaction sub-scores
Radiographic Analysis	Minimum of two years post-surgery.	Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration, and the presence and progression of radiolucent lines between the prosthesis, bone and cement.
Knee Society Score (KSS) Objective Measures	Minimum of two years post-surgery.

Trial Locations

Locations (1)

Tri County Orthopeadic Center; 🇺🇸 Leesburg, Florida, United States