Fixed Bearing Versus Mobile Bearing Patient Satisfaction and Clinical Outcome Study

A Retrospective, Consecutive Series, Single Surgeon Study Comparing Patient Satisfaction and Clinical Outcomes in Patients With Fixed Bearing Versus Mobile Bearing Unicompartmental Knee Arthroplasty

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.

Study Overview

• Status: Withdrawn
• Conditions: Osteoarthritis
• Intervention / Treatment: Device: Fixed Bearing or Mobile Bearing UKA

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Florida
    • Leesburg, Florida, United States, 34748
      • Tri County Orthopeadic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients that have undergone a Unicompartment Knee Replacement with a Fixed Bearing or Mobile Bearing prosthesis.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fixed Bearing or Mobile Bearing UKA	Device: Fixed Bearing or Mobile Bearing UKA; Fixed Bearing or Mobile Bearing UKA Patients who have undergone a primary Fixed Bearing or a Mobile Bearing UKA in either knee and are at a minimum 2 years post-op.; Other Names: Zimmer Unicompartmental High Flex Knee System or Oxford Mobile Bearing

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Injury and Osteoarthritis Outcome Score (KOOS)	Knee symptoms, pain, function and Qol	Minimum of two years post-surgery.
Forgotten Joint Score (FJS)	Knee Function-patients ability to forget the artificial joint in everyday life	Minimum of two years post-surgery.
Knee Society Score (KSS) subjective measures	patient expectation and satisfaction sub-scores	Minimum of two years post-surgery.
Euro-Qual Health related Quality of Life	General Health Status	Minimum of two years post-surgery.
Return to Work History	Questionnaire for work history prior to surgery and after surgery	Minimum of two years post-surgery.
Radiographic Analysis	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.	Minimum of two years post-surgery.
Knee Society Score (KSS) Objective Measures		Minimum of two years post-surgery.
Demographics		Minimum of two years post-surgery.
Complications	Complications will be recorded	Minimum of two years post-surgery.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sub-Study 1: Fixed Bearing Meta-analysis	Full Knee Society Score (KSS) and Short Form Health Survey SF-12	Minimum of two years post-surgery.
Sub Study 2: Prosthesis positing versus outcomes analysis	CT scan of Fixed Bearing patients for implant position	Minimum of two years post-surgery.

Collaborators and Investigators

• Sponsor: Medacta USA
• Investigators: Study Director: Mukesh Ahuja, MBBS, MS, Medacta USA, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): March 22, 2023
• Study Completion (Actual): March 22, 2023

Study Registration Dates

• First Submitted: December 15, 2015
• First Submitted That Met QC Criteria: December 16, 2015
• First Posted (Estimate): December 17, 2015

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Unicompartment Knee Replacement
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: #002 FB vs MB