Fixed Bearing Versus Mobile Bearing Patient Satisfaction and Clinical Outcome Study

• Sponsor: Medacta USA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02633085
• Collaborator: (none)
• Enrollment: 116
• Location: 1
• Duration (Months): 73.9
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Device: Fixed Bearing or Mobile Bearing UKA

Study Design

• Study Type: Observational
• Actual Enrollment: 116 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• 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
• Study Start Date: Feb 1, 2016
• Actual Primary Completion Date: Mar 30, 2022
• Actual Study Completion Date: Mar 30, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

1. Knee Injury and Osteoarthritis Outcome Score (KOOS) [Minimum of two years post-surgery.]

   Knee symptoms, pain, function and Qol

2. Forgotten Joint Score (FJS) [Minimum of two years post-surgery.]

   Knee Function-patients ability to forget the artificial joint in everyday life

3. Knee Society Score (KSS) subjective measures [Minimum of two years post-surgery.]

   patient expectation and satisfaction sub-scores

4. Euro-Qual Health related Quality of Life [Minimum of two years post-surgery.]

   General Health Status

5. Return to Work History [Minimum of two years post-surgery.]

   Questionnaire for work history prior to surgery and after surgery

6. 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.

7. Knee Society Score (KSS) Objective Measures [Minimum of two years post-surgery.]

8. Demographics [Minimum of two years post-surgery.]

9. Complications [Minimum of two years post-surgery.]

   Complications will be recorded

Other Outcome Measures

1. Sub-Study 1: Fixed Bearing Meta-analysis [Minimum of two years post-surgery.]

   Full Knee Society Score (KSS) and Short Form Health Survey SF-12

2. Sub Study 2: Prosthesis positing versus outcomes analysis [Minimum of two years post-surgery.]

   CT scan of Fixed Bearing patients for implant position

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tri County Orthopeadic Center	Leesburg	Florida	United States	34748

Sponsors and Collaborators

• Medacta USA

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medacta USA
• ClinicalTrials.gov Identifier: NCT02633085
• Other Study ID Numbers: #002 FB vs MB
• First Posted: Dec 17, 2015
• Last Update Posted: Apr 1, 2022
• Last Verified: Mar 1, 2022

• Keywords provided by Medacta USA: Unicompartment Knee Replacement
• Additional relevant MeSH terms: Osteoarthritis

Study Results

No Results Posted as of Apr 1, 2022