Multicentre GMK UNI Anatomical Cementless Study - FR

PROSPECTIVE, MULTICENTRE POST-MARKETING SURVEILLANCE STUDY to ASSESS PERFORMANCE of the GMK UNI ANATOMICAL CEMENTLESS IMPLANT

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis of the Knee; Avascular Necrosis of the Femoral Condyle; Revision Surgery

• Study Type: Observational
• Enrollment (Actual): 249

Contacts and Locations

Study Locations

• France
  • Bourgoin-Jallieu, France, 38300
    • Clinique Saint Vincent de Paul
  • Caen, France, 14000
    • Polyclinique du Parc
  • La Rochelle, France, 17000
    • Clinique du Mail
  • Saint-Étienne, France, 42100
    • Centre ORTHEO
• Switzerland
  • Solothurn, Switzerland, CH-4500
    • Bürgerspital Solothurn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients who meet the inclusion/exclusion criteria to take part to the current clinical study will be invited to participate before the surgery.

Description

Inclusion Criteria:

• 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.

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 a revision surgery
• Patients unable to understand and take action;
• Any case not described in the inclusion criteria;
• Patients aged under 18 years;
• Patients aged over 75 years;

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New Knee Society Score (KSS)	The new Knee Society Knee Scoring System is both physician and patient derived. It includes versions to be administered preoperatively and postoperatively. It has an initial assessment of demographic details, including an expanded Charnley functional classification. The objective knee score, completed by the surgeon, includes a VAS score of pain walking on level ground and on stairs or inclines, as well as an assessment of alignment, ligament stability, and ROM, along with deductions for flexion contracture or extensor lag. Patients then record their satisfaction, functional activities, and expectations. Given the diverse activity profiles of many contemporary patients, the functional component of the score was improved to include a patient-specific survey, which evaluates features such as standard activities of daily living, patient-specific sports and recreational activities, patient satisfaction, and patient expectations	Preoperative, 3 months, 1, 2, 3, 5, 7 and 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kujala Score	The "Kujala Score" is the eponymous name for the Anterior Knee Pain Scale (AKPS). It is a patient-reported outcome survey and diagnostic tool that aims to assess the severity of symptoms and physical limitations in patients with patellofemoral pain syndrome (PFPS). The Kujala Score is a self-administered questionnaire for PFPS patients consisting of 13 questions that relate to specified activities, pain severity, and clinical symptoms. It is scored out of 100 points, which represents the summation of the scores for each individual question	3 months, 1, 2, 3, 5, 7 and 10 years
Survival of the implant	Survival rate assessed with Kaplan Meier analysis	3 months, 1, 2, 3, 5, 7 and 10 years
Safety of the implant	Recording of any adverse event and complication (including but not limited to: infection, loosening, deep venous thrombosis (DVT), fracture, reflex sympathetic dystrophy syndrome (RSD).)	Intraoperative, 3 months, 1, 2, 3, 5, 7 and 10 years

Collaborators and Investigators

• Sponsor: Medacta International SA

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2017
• Primary Completion (Estimated): March 6, 2032
• Study Completion (Estimated): March 6, 2032

Study Registration Dates

• First Submitted: November 29, 2024
• First Submitted That Met QC Criteria: November 29, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathologic Processes; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Necrosis; Osteoarthritis, Knee
• Other Study ID Numbers: P02.018.02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No