NCT03522025

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
2 countries

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Feb 2019Dec 2026

First Submitted

Initial submission to the registry

April 27, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

February 15, 2019

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

7.8 years

First QC Date

April 27, 2018

Last Update Submit

September 22, 2025

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

  • Comparing the occurrence of radiolucency's lines

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

    5 yrs

Secondary Outcomes (6)

  • Anterior Knee Pian Scale (Kujala score)

    pre-op; 3months;1,2,3,5 yrs

  • Implant survival rate using Kaplan Meier analysis

    5 yrs

  • Recording of adverse events

    Throughout the study

  • Oxford Knee Score

    Pre-op;3month;1,2,3,5yrs

  • New Knee Society Score

    Pre-op:3months;1,2,3,5 yrs

  • +1 more secondary outcomes

Study Arms (2)

GMK-UNI cemented fixation prosthesis

ACTIVE COMPARATOR

Unicompartmental Knee Arthroplasty (UKA)

Device: Unicompartmental Knee Arthroplasty (UKA)

GMK-UNI cementless fixation prosthesis

EXPERIMENTAL

Unicompartmental Knee Arthroplasty (UKA)

Device: Unicompartmental Knee Arthroplasty (UKA)

Interventions

Unicompartmental Knee Arthroplasty (UKA)DEVICE

Unicompartmental Knee Arthroplasty (UKA) is a less invasive treatment option compared to Total Knee Arthroplasty (TKA) for patients with primary anteromedial knee osteoarthritis.

GMK-UNI cemented fixation prosthesisGMK-UNI cementless fixation prosthesis

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • Patients aged under 18 years;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Clinique Saint Vincent de Paul

Bourgoin, France, 38300, France

Location

Clinique du Mail

La Rochelle, France, 17000, France

Location

Centre Orthéo, Espace Fauriel

Saint-Etienne, France, 42100, France

Location

CHP Saint-Grégoire

Saint-Grégoire, France, 35760, France

Location

Dr. Näder Helmy

Solothurn, Switzerland, 4500, Switzerland

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2018

First Posted

May 11, 2018

Study Start

February 15, 2019

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 25, 2025

Record last verified: 2025-09

Locations

CH(1)FR(4)