Fixed Bearing Versus Mobile Bearing Patient Satisfaction and Clinical Outcome Study

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02633085
• Other study ID #: #002 FB vs MB
• Status: Withdrawn
• Start date: February 2016
• Est. completion date: March 22, 2023

Study information

• Verified date: March 2023
• Source: Medacta USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 22, 2023
• Est. primary completion date: March 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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.

Locations

Country	Name	City	State
United States	Tri County Orthopeadic Center	Leesburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Medacta USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	Sub Study 2: Prosthesis positing versus outcomes analysis	CT scan of Fixed Bearing patients for implant position	Minimum of two years post-surgery.
Primary	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	Knee Injury and Osteoarthritis Outcome Score (KOOS)	Knee symptoms, pain, function and Qol	Minimum of two years post-surgery.
Secondary	Forgotten Joint Score (FJS)	Knee Function-patients ability to forget the artificial joint in everyday life	Minimum of two years post-surgery.
Secondary	Knee Society Score (KSS) subjective measures	patient expectation and satisfaction sub-scores	Minimum of two years post-surgery.
Secondary	Euro-Qual Health related Quality of Life	General Health Status	Minimum of two years post-surgery.
Secondary	Return to Work History	Questionnaire for work history prior to surgery and after surgery	Minimum of two years post-surgery.
Secondary	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.
Secondary	Knee Society Score (KSS) Objective Measures		Minimum of two years post-surgery.
Secondary	Demographics		Minimum of two years post-surgery.
Secondary	Complications	Complications will be recorded	Minimum of two years post-surgery.