The Medacta International GMK Sphere Cementless Post-Marketing Surveillance Study

NCT05003414 | Active Not Recruiting

• 1 other identifier: P02.014.26
• Study Type: observational
• Target: 200
• Locations: 2 countries
• Sites: 5

Brief Summary

This is a Post-Marketing Surveillance study of GMK Sphere cementless knee prosthesis.

Conditions

Arthritis; Traumatic Arthritis; Rheumatoid Arthritis; Poly-arthritis; Avascular Necrosis

Outcome Measures

Primary Outcomes (1)

• Survival rate

  Kaplan Meier method

  10 years

Secondary Outcomes (4)

• Clinical outcome: Knee Society score

  Preop and 1, 2, 5, 10 years postop

• Patient-reported outcome: Forgotten Joint Score

  1, 2, 5, 10 years postop

• Radiographic performance of the implants looking for radiolucencies, migration, loosening, subsidence

  Immediately postop + 1, 2, 5, 10 years postop

• Intraoperative and postoperative Adverse events

  Intraop + Immediately postop + 1, 2, 5, 10 years postop

Interventions

GMK Sphere cementless Knee Replacement DEVICE

Performance of Total Knee Arthroplasty (TKA) with GMK Sphere cementless Knee Replacement

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients requiring Total Knee Arthroplasty and who are suitable to receive Medacta GMK Sphere cementless Knee Replacement will be proposed to take part to the current post-market surveillance study during their pre-operative visit.

You may qualify if:

• A disabled or severely disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis, poly-arthritis or avascular necrosis
• Patients between the age of 18 and 80 at the time of consent
• Listed for total knee replacement surgery.
• Patients who are willing and able to give informed written consent

You may not qualify if:

• Progressive local or systemic infection
• Muscular loss, neuromuscular disease or vascular deficiency of the affected limb, making the operation unjustifiable
• Severe instability secondary to advance destruction of condralar structures or loss of integrity of the medial or lateral ligament
• Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
• Patient whose BMI exceeds 40

Sponsors & Collaborators

• Medacta International SA: lead

Study Sites (5)

Clinique Saint Vincent de Paul

Bourgoin, 38300, France

Location

Clinique du Parc

Caen, 14000, France

Location

Hôpitaux Civils de Colmar

Colmar, 68000, France

Location

Clinique des Acacias

Cucq, 62780, France

Location

Hôpital de la Tour

Meyrin, CH-1217, Switzerland

Location

MeSH Terms

Conditions

Arthritis; Arthritis, Rheumatoid; Osteonecrosis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emmanuel Marchetti, MD

  Clinique Saint Vincent de Paul

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 12, 2021
• Study Start: January 14, 2020
• Primary Completion (Estimated): January 31, 2030
• Study Completion (Estimated): December 31, 2032
• Last Updated: September 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4); CH (1)