Fixed Bearing Versus Mobile Bearing Patient Satisfaction and Clinical Outcome Study

NCT02633085 | Withdrawn

• 1 other identifier: #002 FB vs MB
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

Unicompartment Knee Replacement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Minimum of two years post-surgery.

• Forgotten Joint Score (FJS)

  Minimum of two years post-surgery.

• Knee Society Score (KSS) subjective measures

  Minimum of two years post-surgery.

• Euro-Qual Health related Quality of Life

  Minimum of two years post-surgery.

• Return to Work History

  Minimum of two years post-surgery.

Other Outcomes (2)

• Sub-Study 1: Fixed Bearing Meta-analysis

  Minimum of two years post-surgery.

• Sub Study 2: Prosthesis positing versus outcomes analysis

  Minimum of two years post-surgery.

Study Arms (1)

Fixed Bearing or Mobile Bearing UKA

Device: Fixed Bearing or Mobile Bearing UKA

Interventions

Fixed Bearing or Mobile Bearing UKA DEVICE

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.

Also known as: Zimmer Unicompartmental High Flex Knee System or Oxford Mobile Bearing

Fixed Bearing or Mobile Bearing UKA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF)
• Ability to understand and provide written authorization for use and disclosure of personal health information.
• Subject who are able and willing to comply with the study protocol and follow-up visit.
• Must be 18 years or older to participate.
• Subjects must have a clinically documented Osteoarthritis in a knee, single or multiple compartments,
• 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.
• Must be a minimum 2 year (24 months) post-surgery on the knee.
• The UKA operation must have been performed by the Investigator.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Medacta USA: lead

Study Sites (1)

Tri County Orthopeadic Center

Leesburg, Florida, 34748, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Mukesh Ahuja, MBBS, MS

  Medacta USA, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 17, 2015
• Study Start: February 1, 2016
• Primary Completion: March 22, 2023
• Study Completion: March 22, 2023
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

US (1)