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Active, Not Recruiting

NCT Number: NCT06715917

Multicentre GMK UNI Anatomical Cementless Study - FR

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Saint Vincent de Paul, Bourgoin, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Primary outcomes

  1. New Knee Society Score (KSS)

    Time frame: Preoperative, 3 months, 1, 2, 3, 5, 7 and 10 years

    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

Secondary outcomes

  1. Kujala Score

    Time frame: 3 months, 1, 2, 3, 5, 7 and 10 years

    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

  2. Survival of the implant

    Time frame: 3 months, 1, 2, 3, 5, 7 and 10 years

    Survival rate assessed with Kaplan Meier analysis

  3. Safety of the implant

    Time frame: Intraoperative, 3 months, 1, 2, 3, 5, 7 and 10 years

    Recording of any adverse event and complication (including but not limited to: infection, loosening, deep venous thrombosis (DVT), fracture, reflex sympathetic dystrophy syndrome (RSD).)

Sponsors and collaborators

Lead sponsor

Medacta International SA

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2032
Study completion
2032
First posted
Dec 4, 2024
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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