Active, not recruitingNo phase
GMK-UNI Anatomical UKA: Fixation of Cemented vs Cementless Designs
Key facts
- Who runs it
- Medacta International SA
- Where
- France and Switzerland5 sites in 2 countriesChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 70 people enrolled
- Started
- 15 Feb 2019
- Expected to end
- 1 Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Unicompartmental Knee Arthroplasty (UKA)
- Record updated
- 25 September 2025
Who can take part
- Age
- 18 years to 95 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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
Who cannot take part
- Patients who need a revision surgery
- Patients who had previously undergone high tibial osteotomy or ACL reconstruction
- Patients with one or more medical conditions identified as a contraindication defined by the labelling on any Medacta implants used in this study
- Patients aged under 18 years
- 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 patella-femoral joint prosthesis
- Patients with BMI ≥ 40 kg/m2
- Patients unable to understand and take action
- Any case not described in the inclusion criteria
This trial has no sites in United States.
It has sites in 2 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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 2 groups in the trial
- GMK-UNI cemented fixation prosthesisExisting treatment, for comparison
Unicompartmental Knee Arthroplasty (UKA)
Treatment: Unicompartmental Knee Arthroplasty (UKA)
- GMK-UNI cementless fixation prosthesisTreatment being tested
Unicompartmental Knee Arthroplasty (UKA)
Treatment: Unicompartmental Knee Arthroplasty (UKA)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Prospective, Multicenter, Randomised Study to Evaluate the Fixation of Cemented and Cementless Design of GMK-UNI Anatomical Knee Prosthesis.
- Record updated
- 25 September 2025