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

Primary Purpose

Osteoarthritis, Knee

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Unicompartmental Knee Arthroplasty (UKA)
Sponsored by
Medacta International SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Osteoarthritis, Knee

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Clinique Saint Vincent de Paul
  • Clinique du Mail
  • Centre Orthéo, Espace Fauriel
  • CHP Saint-Grégoire
  • Dr. Näder Helmy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

GMK-UNI cemented fixation prosthesis

GMK-UNI cementless fixation prosthesis

Arm Description

Unicompartmental Knee Arthroplasty (UKA)

Unicompartmental Knee Arthroplasty (UKA)

Outcomes

Primary Outcome Measures

Comparing the occurrence of radiolucency's lines
Compare occurrence of radiolucency's lines (both partial and complete)between the two study groups

Secondary Outcome Measures

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.
Implant survival rate using Kaplan Meier analysis
Implant survival rate
Recording of adverse events
Any complication occurred during 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.
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)
Stability and fixation of unicompartmental prosthesis
To evaluate the stability and fixation of the prosthesis

Full Information

First Posted
April 27, 2018
Last Updated
March 31, 2023
Sponsor
Medacta International SA
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1. Study Identification

Unique Protocol Identification Number
NCT03522025
Brief Title
GMK-UNI Anatomical UKA: Fixation of Cemented vs Cementless Designs
Official Title
A Prospective, Multicenter, Randomised Study to Evaluate the Fixation of Cemented and Cementless Design of GMK-UNI Anatomical Knee Prosthesis.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 15, 2019 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medacta International SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GMK-UNI cemented fixation prosthesis
Arm Type
Active Comparator
Arm Description
Unicompartmental Knee Arthroplasty (UKA)
Arm Title
GMK-UNI cementless fixation prosthesis
Arm Type
Experimental
Arm Description
Unicompartmental Knee Arthroplasty (UKA)
Intervention Type
Device
Intervention Name(s)
Unicompartmental Knee Arthroplasty (UKA)
Intervention Description
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 Measure Information:
Title
Comparing the occurrence of radiolucency's lines
Description
Compare occurrence of radiolucency's lines (both partial and complete)between the two study groups
Time Frame
5 yrs
Secondary Outcome Measure Information:
Title
Anterior Knee Pian Scale (Kujala score)
Description
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
Title
Implant survival rate using Kaplan Meier analysis
Description
Implant survival rate
Time Frame
5 yrs
Title
Recording of adverse events
Description
Any complication occurred during the study
Time Frame
Throughout the study
Title
Oxford Knee Score
Description
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
Title
New Knee Society Score
Description
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
Title
Stability and fixation of unicompartmental prosthesis
Description
To evaluate the stability and fixation of the prosthesis
Time Frame
5 yrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Facility Information:
Facility Name
Clinique Saint Vincent de Paul
City
Bourgoin-Jallieu
ZIP/Postal Code
38300
Country
France
Facility Name
Clinique du Mail
City
La Rochelle
ZIP/Postal Code
17000
Country
France
Facility Name
Centre Orthéo, Espace Fauriel
City
Saint Etienne
ZIP/Postal Code
42100
Country
France
Facility Name
CHP Saint-Grégoire
City
Saint-Grégoire
ZIP/Postal Code
35760
Country
France
Facility Name
Dr. Näder Helmy
City
Solothurn
ZIP/Postal Code
4500
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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