Multicentre GMK UNI Anatomical Cementless Study - FR

NCT06715917 | Active Not Recruiting

• 1 other identifier: P02.018.02
• Study Type: observational
• Target: 249
• Locations: 2 countries
• Sites: 5

Brief Summary

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.

Conditions

Osteoarthritis of the Knee; Avascular Necrosis of the Femoral Condyle; Revision Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Kujala Score

  3 months, 1, 2, 3, 5, 7 and 10 years

• Survival of the implant

  3 months, 1, 2, 3, 5, 7 and 10 years

• Safety of the implant

  Intraoperative, 3 months, 1, 2, 3, 5, 7 and 10 years

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

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 a revision surgery
• Patients unable to understand and take action;
• Patients aged under 18 years;
• Patients aged over 75 years;

Sponsors & Collaborators

• Medacta International SA: lead

Study Sites (5)

Clinique Saint Vincent de Paul

Bourgoin, 38300, France

Location

Polyclinique du Parc

Caen, 14000, France

Location

Clinique du Mail

La Rochelle, 17000, France

Location

Centre Orthéo

Saint-Etienne, 42100, France

Location

Bürgerspital Solothurn

Solothurn, CH-4500, Switzerland

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: March 6, 2017
• Primary Completion (Estimated): March 6, 2032
• Study Completion (Estimated): March 6, 2032
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

CH (1); FR (4)