The Medacta International GMK Sphere Cementless Post-Marketing Surveillance Study

Recruiting

• Conditions: Traumatic Arthritis; Arthritis; Poly-arthritis; Avascular Necrosis; Rheumatoid Arthritis

• Registration Number: NCT05003414
• Lead Sponsor: Medacta International SA

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-14
• Study First Submitted: 2021-08-06
• Study First Submitted QC: 2021-08-06
• Study First Posted: 2021-08-12
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-16
• Primary Completion: 2030-01-31
• Study Completion: 2032-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival rate	10 years	Kaplan Meier method

Secondary Outcome Measures

Name	Time	Method
Clinical outcome: Knee Society score	Preop and 1, 2, 5, 10 years postop	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.
Patient-reported outcome: Forgotten Joint Score	1, 2, 5, 10 years postop	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
Radiographic performance of the implants looking for radiolucencies, migration, loosening, subsidence	Immediately postop + 1, 2, 5, 10 years postop	Presence of radiolucencies, migration, loosening, subsidence
Intraoperative and postoperative Adverse events	Intraop + Immediately postop + 1, 2, 5, 10 years postop	Intraoperative and postoperative adverse events

Trial Locations

Locations (5)

Hôpitaux Civils de Colmar; 🇫🇷 Colmar, France

Hôpital de la Tour; 🇨🇭 Meyrin, Switzerland

Clinique des Acacias; 🇫🇷 Cucq, France

Clinique du Parc; 🇫🇷 Caen, France

Clinique Saint Vincent de Paul; 🇫🇷 Bourgoin-Jallieu, France