Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

GMK-UNI Anatomical UKA: Fixation of Cemented vs Cementless Designs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03522025
Recruitment Status : Recruiting
First Posted : May 11, 2018
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Device: Unicompartmental Knee Arthroplasty (UKA) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Prospective, Multicenter, Randomised Study to Evaluate the Fixation of Cemented and Cementless Design of GMK-UNI Anatomical Knee Prosthesis.
Actual Study Start Date : March 14, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: GMK-UNI cemented fixation prosthesis
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.

Experimental: GMK-UNI cementless fixation prosthesis
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.




Primary Outcome Measures :
  1. Comparing the occurrence of radiolucency's lines [ Time Frame: 5 yrs ]
    Compare occurrence of radiolucency's lines (both partial and complete)between the two study groups


Secondary Outcome Measures :
  1. Anterior Knee Pian Scale (Kujala score) [ Time Frame: 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.

  2. Implant survival rate using Kaplan Meier analysis [ Time Frame: 5 yrs ]
    Implant survival rate

  3. Recording of adverse events [ Time Frame: Throughout the study ]
    Any complication occurred during the study

  4. Oxford Knee Score [ Time Frame: 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.

  5. New Knee Society Score [ Time Frame: 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)

  6. Stability and fixation of unicompartmental prosthesis [ Time Frame: 5 yrs ]
    To evaluate the stability and fixation of the prosthesis



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee that meet the indications for use according to Medacta implants included in this study (on-label use);
  • Those suffering from unilateral osteoarthritis or osteonecrosis of the medial compartment;
  • Frontal deformity < 10° (evaluated on weight-bearing long-axis x-rays);
  • Flexion contracture < 10°;
  • Intact ligaments;
  • Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery;
  • Patient's age over 18 years old;
  • Patient with BMI < 40 kg/m2;
  • Patients must be willing to comply with the pre and post-operative evaluation schedule.

Exclusion criteria:

  • Patients with one or more medical conditions identified as a contraindication defined by the labelling on any Medacta implants used in this study;
  • Any patient who cannot or will not provide informed consent for participation in the study;
  • Patients who need to undergo lateral unicompartmental knee arthroplasty;
  • Patients who need a revision surgery;
  • Patients who need a patella-femoral joint prosthesis;
  • Patients who had previously undergone high tibial osteotomy or ACL reconstruction;
  • Patients with BMI ≥ 40 kg/m2;
  • Patients unable to understand and take action;
  • Any case not described in the inclusion criteria;
  • Patients aged under 18 years;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522025


Contacts
Layout table for location contacts
Contact: Dario Bergadano 00 41 91 690 60 60 bergadano@medacta.ch

Locations
Layout table for location information
France
Clinique Saint Vincent de Paul Not yet recruiting
Bourgoin-Jallieu, France, 38300
Contact: Emmanuel MARCHETTI    04 74 43 60 60    emmanuelmarchetti@yahoo.fr   
Clinique du Mail Not yet recruiting
La Rochelle, France, 17000
Contact: Cedric BOUQUET    05 46 00 43 34    docteurbouquet@gmail.com   
Centre Orthéo, Espace Fauriel Not yet recruiting
Saint Etienne, France, 42100
Contact: François CHALENCON    04 77 42 09 82    fchalencon@ortheo.org   
CHP Saint-Grégoire Not yet recruiting
Saint-Grégoire, France, 35760
Contact: Yvan ACQUITTER    02 23 25 30 75    acquitter-y@wanadoo.fr   
Switzerland
Dr. Näder Helmy Recruiting
Solothurn, Switzerland, 4500
Contact: Näder Helmy    0041 032 627 31 21    Naeder.Helmy@spital.so.ch   
Sponsors and Collaborators
Medacta International SA
Layout table for additonal information
Responsible Party: Medacta International SA
ClinicalTrials.gov Identifier: NCT03522025    
Other Study ID Numbers: 2017-01677
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases