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WithdrawnNCT02583113Updated Mar 20, 2023

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

An observational study in Osteoarthritis, sponsored by Medacta USA. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-20.

Sponsored by Medacta USA · Observational

Why this study was withdrawn
Alternate Research Pursued
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
0
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Osteoarthritis

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Keywords

  • Total Knee Replacement
  • Unicompartment Knee Replacement
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In context

Osteoarthritis

4,399 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.

Browse Osteoarthritis studies →

Lead sponsor

Medacta USA is the lead sponsor of 13 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • Total and Unicompartment Knee Replacement

    Device: Total and Unicompartment Knee Replacement

Interventions

  • DeviceTotal 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.

    Also known as: TKA UKA

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What researchers measure

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"

    Time frame: Minimum 2 years post surgery

Secondary outcomes

  1. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Knee symptoms, pain, function, and QoL

    Time frame: Minimum 2 years post-op

  2. Forgotten Joint Score (FJS)

    Knee function-patient's ability to forget the artificial joint in everyday life

    Time frame: Minimum of 2 years post-op

  3. Knee Society Score (KSS) subjective measures

    Patient Expectation and Satisfaction Sub-scores

    Time frame: Minimum of 2 years post-op

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

    General health status

    Time frame: Minimum of 2 years post-op

  5. Return to work history

    Questionnaire for work history prior to surgery and after surgery

    Time frame: Minimum of 2 years post-op

  6. 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.

    Time frame: Pre-operative and minimum of 2 years post-op

  7. Knee Society Score (KSS) Objective measures

    Time frame: Minimum of 2 years post-op

  8. Demographics

    Time frame: Pre-operative and Minimum of 2 years post-op

Other outcomes

  1. Complications will be recorded

    Time frame: Pre-operative and minimum 2 years post-operative

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Study locations

1 site
  • Tri County Orthopeadic Center
    Leesburg, Florida 34748, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02583113
Lead sponsor
Medacta USA
Responsible party
Sponsor
First posted
Oct 21, 2015
Start date
Feb 2016
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Mar 20, 2023

Study contacts

Mukesh Ahuja, MBBS, MS
study director · Medacta USA, Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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