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

NCT02583113 | Withdrawn

• 1 other identifier: UNI 001
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

Total Knee Replacement; Unicompartment Knee Replacement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Minimum 2 years post-op

• Forgotten Joint Score (FJS)

  Minimum of 2 years post-op

• Knee Society Score (KSS) subjective measures

  Minimum of 2 years post-op

• Euro-Qual Health Related Quality of Life (EQ-5D)

  Minimum of 2 years post-op

• Return to work history

  Minimum of 2 years post-op

Other Outcomes (1)

• Complications will be recorded

  Pre-operative and minimum 2 years post-operative

Study Arms (1)

Total and Unicompartment Knee Replacement

Device: Total and Unicompartment Knee Replacement

Interventions

Total and Unicompartment Knee Replacement DEVICE

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.

Also known as: TKA UKA

Total and Unicompartment Knee Replacement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients that have undergone a Total Knee and Unicompartment knee replacement contralateral.

You may qualify if:

• Must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF)
• Ability to understand and provide written authorization for use and disclosure of personal health information
• Subject who are able and willing to comply with the study protocol and follow-up visit
• Must be 18 years or older to participate
• Subjects must have a clinically documented osteoarthritis in both knees, single or multiple compartments
• Subjects must have undergone a primary TKA and primary UKA in the contralateral knee
• Must be a minimum 2 year (24 months) post-surgery on each knee
• One or both TKA/UKA surgeries must have been performed by the Principal Investigator.
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Medacta USA: lead

Study Sites (1)

Tri County Orthopeadic Center

Leesburg, Florida, 34748, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Mukesh Ahuja, MBBS, MS

  Medacta USA, Inc

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 21, 2015
• Study Start: February 1, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 20, 2023

Record last verified: 2023-03

Locations

US (1)