An interventional study of Unicompartmental Knee Arthroplasty (UKA) in Osteoarthritis, Knee, sponsored by Medacta International SA. Active, not recruiting at 5 sites in 2 countries. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2025-09-25.
Sponsored by Medacta International SA · Not applicable, Interventional, and Other
Unicompartmental knee arthroplasty (UKA) is the principal surgical alternative to the total knee arthroplasty (TKA) in patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee. The current comparative randomized study aims to evaluate the fixation of cemented and cementless designs of GMK-UNI unicompartmental knee prosthesis over a 5-year time period.
The Primary objective is to compare the quality of fixation of cemented and cementless designs of GMK-UNI unicompartmental knee replacement at 2 years of follow-up.
The Secondary objectives include the evaluation of the patient improvement (subjective and objective) using the new Knee Society Score (KSS); the patient's anterior pain following UKA and any eventual patella-femoral disorder; Implant survival rate using the Kaplan Meier analysis; Post-op radiological findings and Adverse Events.
The Primary outcome aims to compare the occurrence of radiolucency's lines (both partial and complete) between the two study groups. Secondary outcomes include New KSS, OKS, Kaplan Meier analysis and stability and fixation of UNI prosthesis.
All patients who meet the inclusion criteria to take part in the current clinical study will be invited to participate before the surgery.
Subjects will be randomized during the screening; half of them will receive the cemented GMK-UNI anatomical UKA and the other half the cementless GMK-UNI anatomical UKA.
Clinical data will be recorded on CRF at those time-points:
3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.
This study's enrollment of 70 is close to the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Medacta International SA is the lead sponsor of 46 studies on the registry; 18 are open to participants now.
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Exclusion criteria:
Unicompartmental Knee Arthroplasty (UKA)
Device: Unicompartmental Knee Arthroplasty (UKA)
Unicompartmental Knee Arthroplasty (UKA)
Device: Unicompartmental Knee Arthroplasty (UKA)
Unicompartmental Knee Arthroplasty (UKA) is a less invasive treatment option compared to Total Knee Arthroplasty (TKA) for patients with primary anteromedial knee osteoarthritis.
Comparing the occurrence of radiolucency's lines
Compare occurrence of radiolucency's lines (both partial and complete)between the two study groups
Time frame: 5 yrs
Anterior Knee Pian Scale (Kujala score)
It's a 13-item knee specific self-report questionnaire. It documents response to 6 activities associated with anterior knee pain as well as symptoms such as limp, inability to weight bear through the affected limp, swelling...). It asks about duration of symptoms and limbs affected. Max score is 100 and lower scores indicate greater pain/disability. Scoring is hierarchical using various types of categorisation including "no difficulty-unable " and "no pain-severe pain". It is easy to understand and takes few minutes to complete.It has a good test-retest reliability.
Time frame: pre-op; 3months;1,2,3,5 yrs
Implant survival rate using Kaplan Meier analysis
Implant survival rate
Time frame: 5 yrs
Recording of adverse events
Any complication occurred during the study
Time frame: Throughout the study
Oxford Knee Score
The Oxford Knee Score (OKS) is a 12-item patient-reported PRO specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty).Each question is scored from 1 to 5, with 1 representing best outcome/least symptoms. Scores from each question are added so the overall score is from 12 to 60 (12 being the best outcome). The overall score for the OKS is acquired by simply summing the scores received for individual questions.
Time frame: Pre-op;3month;1,2,3,5yrs
New Knee Society Score
The new KSS System is a validated and responsive method for assessing objective and subjective outcomes after total and partial knee arthroplasty.It includes versions to be admninstered pre-op and post-op.It has an initial assessment of demographic deatils. The objective knee score includes VAS score of pain walking on level ground and on stairs or inclines, as well as ROM, an assessment of alignment, ligament stability along with deductions for flexion contracture or extensor lag. Pts then record their satisfaction, functional activities and expectations. It consists of 4 subscales: 1) objective knee score (7 items;100 points); 2) Satisfaction Score (5 items; 40 points);3) Expectation Score (3 items; 15 points); 4) Functional Activity Score (19 items; 100 points)
Time frame: Pre-op:3months;1,2,3,5 yrs
Stability and fixation of unicompartmental prosthesis
To evaluate the stability and fixation of the prosthesis
Time frame: 5 yrs
Plan to share: Undecided
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This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Medacta International SA