Active, not recruitingNo phase
Multicentre GMK UNI Anatomical Cementless Study - FR
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
- 249 people enrolled
- Started
- 6 Mar 2017
- Expected to end
- 6 Mar 2032
- Type of study
- Observational
- Record updated
- 16 December 2024
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- Patients presenting with disease that meets the indications for use for Medacta implants included in this study (on-label use)
- 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 between 18 and 75 years old
- Patients must be willing to comply with the pre and postoperative evaluation schedule
Who cannot take part
- Patients who need a revision surgery
- 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
- Patients aged over 75 years
- Any patient who cannot or will not provide informed consent for participation in the study
- 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 Total Knee Arthroplasty (TKA) in patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee. The current post-marketing surveillance study aims to monitor GMK-UNI monocompartmental knee prosthesis performances over a 10-year time period.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- PROSPECTIVE, MULTICENTRE POST-MARKETING SURVEILLANCE STUDY to ASSESS PERFORMANCE of the GMK UNI ANATOMICAL CEMENTLESS IMPLANT
- Record updated
- 16 December 2024