GMK-UNI Anatomical UKA: Fixation of Cemented Vs Cementless Designs
- Conditions
- Osteoarthritis, Knee
- Interventions
- Device: Unicompartmental Knee Arthroplasty (UKA)
- Registration Number
- NCT03522025
- Lead Sponsor
- Medacta International SA
- Brief Summary
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.
- Detailed Description
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:
* Before the surgery
* During the surgery
* After the surgery at 3 months, 1, 2, 3 and 5 years.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 70
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GMK-UNI cemented fixation prosthesis Unicompartmental Knee Arthroplasty (UKA) Unicompartmental Knee Arthroplasty (UKA) GMK-UNI cementless fixation prosthesis Unicompartmental Knee Arthroplasty (UKA) Unicompartmental Knee Arthroplasty (UKA)
- Primary Outcome Measures
Name Time Method Comparing the occurrence of radiolucency's lines 5 yrs Compare occurrence of radiolucency's lines (both partial and complete)between the two study groups
- Secondary Outcome Measures
Name Time Method Anterior Knee Pian Scale (Kujala score) pre-op; 3months;1,2,3,5 yrs 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.
Recording of adverse events Throughout the study Any complication occurred during the study
New Knee Society Score Pre-op:3months;1,2,3,5 yrs 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)
Implant survival rate using Kaplan Meier analysis 5 yrs Implant survival rate
Oxford Knee Score Pre-op;3month;1,2,3,5yrs 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.
Stability and fixation of unicompartmental prosthesis 5 yrs To evaluate the stability and fixation of the prosthesis
Trial Locations
- Locations (5)
Dr. Näder Helmy
🇨🇭Solothurn, Switzerland
Clinique Saint Vincent de Paul
🇫🇷Bourgoin-Jallieu, France
CHP Saint-Grégoire
🇫🇷Saint-Grégoire, France
Clinique du Mail
🇫🇷La Rochelle, France
Centre Orthéo, Espace Fauriel
🇫🇷Saint Etienne, France