Bilateral Total Knee Arthroplasty vs Unicompartment Arthroplasty Retrospective and Clinical Outcome Study

Withdrawn

• Conditions: Osteoarthritis
• Interventions: Device: Total and Unicompartment Knee Replacement

• Registration Number: NCT02583113
• Lead Sponsor: Medacta USA

Brief Summary

To determine if there is a patient satisfaction preference of Total Knee Arthroplasty (TKA) vs Unicompartmental Knee Arthroplasty (UKA) in patients with bilateral knee osteoarthritis who underwent a primary TKA one side and a primary UKA on the opposite side and are at a minimum of two years post-surgery. Patient reported outcomes and data with be analyzed along with all retrospective chart data.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-20
• Study First Submitted QC: 2015-10-20
• Study First Posted: 2015-10-21
• Study Start: 2016-02
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-16
• Last Update Posted: 2023-03-20
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

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• Status: WITHDRAWN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 both knees, single or multiple compartments
6. Subjects must have undergone a primary TKA and primary UKA in the contralateral knee
7. Must be a minimum 2 year (24 months) post-surgery on each knee
8. One or both TKA/UKA surgeries must have been performed by the Principal 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 radiographs

Exclusion Criteria

1. Subjects who underwent UKA with Patella Femoral Joint (PFJ) replacement on the same side.
2. Women who are pregnant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Total and Unicompartment Knee Replacement	Total and Unicompartment Knee Replacement	-

Primary Outcome Measures

Name	Time	Method
To evaluate patient preference of Total Knee Arthroplasty (TKA) vs Unicompartmental Knee Arthroplasty (UKA)	Minimum 2 years post surgery	Asking patients "which is your better knee overall"

Secondary Outcome Measures

Name	Time	Method
Forgotten Joint Score (FJS)	Minimum of 2 years post-op	Knee function-patient's ability to forget the artificial joint in everyday life
Knee Society Score (KSS) subjective measures	Minimum of 2 years post-op	Patient Expectation and Satisfaction Sub-scores
Euro-Qual Health Related Quality of Life (EQ-5D)	Minimum of 2 years post-op	General health status
Return to work history	Minimum of 2 years post-op	Questionnaire for work history prior to surgery and after surgery
Knee Injury and Osteoarthritis Outcome Score (KOOS)	Minimum 2 years post-op	Knee symptoms, pain, function, and QoL
Knee Society Score (KSS) Objective measures	Minimum of 2 years post-op
Radiographic Analysis	Pre-operative and minimum of 2 years post-op	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.
Demographics	Pre-operative and Minimum of 2 years post-op

Trial Locations

Locations (1)

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