The Medacta International GMK Sphere Cementless Post-Marketing Surveillance Study

Rheumatoid Arthritis Clinical Trial

Official title:

A Prospective, Multicentre, International, Post-marketing, Longitudinal, Observational Cohort Study to Monitor the Performances of GMK Sphere Cementless Knee Prosthesis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05003414
• Other study ID #: P02.014.26
• Status: Recruiting
• Start date: January 14, 2020
• Est. completion date: December 31, 2032

Study information

• Verified date: March 2023
• Source: Medacta International SA
• Contact: Denise Falcone
• Phone: +41916966060
• Email: falcone[@]medacta.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2032
• Est. primary completion date: January 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Any case not described in the inclusion criteria

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
France	Clinique Saint Vincent de Paul	Bourgoin-Jallieu
France	Clinique du Parc	Caen
France	Hôpitaux Civils de Colmar	Colmar
France	Clinique des Acacias	Cucq
Switzerland	Hôpital de la Tour	Meyrin

Sponsors (1)

Lead Sponsor	Collaborator
Medacta International SA

Countries where clinical trial is conducted

France,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate	Kaplan Meier method	10 years
Secondary	Clinical outcome: Knee Society score	Knee Society Score (KSS): evaluates pain, in a total of 50 points, stability, 25 points, and range of motion, 25 points. The maximum score of 100 points is reached when there is no pain, with good alignment of the knee in extension, and at least 125° of range of motion, without any anteroposterior or mediolateral instability.	Preop and 1, 2, 5, 10 years postop
Secondary	Patient-reported outcome: Forgotten Joint Score	Forgotten Joint Score (FJS) is a patient-reported outcome measure intended to determine a patient's ability to "forget" about their affected joint after surgery or treatment.It consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities	1, 2, 5, 10 years postop
Secondary	Radiographic performance of the implants looking for radiolucencies, migration, loosening, subsidence	Presence of radiolucencies, migration, loosening, subsidence	Immediately postop + 1, 2, 5, 10 years postop
Secondary	Intraoperative and postoperative Adverse events	Intraoperative and postoperative adverse events	Intraop + Immediately postop + 1, 2, 5, 10 years postop