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

Osteoarthritis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02583113
• Other study ID #: UNI 001
• Status: Withdrawn
• Start date: February 2016
• Est. completion date: December 1, 2026

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2026
• 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 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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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.

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