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

A Retrospective Consecutive Series Patient Preference and Clinical Outcomes Study in Bilateral Knee Osteoarthritis Patients With Both Total Knee Arthroplasty and Unicompartment Knee Arthroplasty Prostheses.

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.

Study Overview

• Status: Withdrawn
• Conditions: Osteoarthritis
• Intervention / Treatment: Device: Total and Unicompartment Knee Replacement

• 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 Total Knee and Unicompartment knee replacement contralateral.

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 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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Total and Unicompartment Knee Replacement	Device: Total and Unicompartment Knee Replacement; Patients who have undergone a primary TKA on one side and primary UKA on the opposite side and are at a minimum of two years post-surgery.; Other Names: TKA UKA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate patient preference of Total Knee Arthroplasty (TKA) vs Unicompartmental Knee Arthroplasty (UKA)	Asking patients "which is your better knee overall"	Minimum 2 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 2 years post-op
Forgotten Joint Score (FJS)	Knee function-patient's ability to forget the artificial joint in everyday life	Minimum of 2 years post-op
Knee Society Score (KSS) subjective measures	Patient Expectation and Satisfaction Sub-scores	Minimum of 2 years post-op
Euro-Qual Health Related Quality of Life (EQ-5D)	General health status	Minimum of 2 years post-op
Return to work history	Questionnaire for work history prior to surgery and after surgery	Minimum of 2 years post-op
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.	Pre-operative and minimum of 2 years post-op
Knee Society Score (KSS) Objective measures		Minimum of 2 years post-op
Demographics		Pre-operative and Minimum of 2 years post-op

Other Outcome Measures

Outcome Measure	Time Frame
Complications will be recorded	Pre-operative and minimum 2 years post-operative

Collaborators and Investigators

• Sponsor: Medacta USA

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): December 1, 2026
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: October 20, 2015
• First Submitted That Met QC Criteria: October 20, 2015
• First Posted (Estimate): October 21, 2015

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Total Knee Replacement; Unicompartment Knee Replacement
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: UNI 001