The Medacta International GMK Sphere Post-Marketing Surveillance Study

Not Applicable

Active, not recruiting

• Conditions: Poly-arthritis; Traumatic Arthritis; Avascular Necrosis; Arthritis; Rheumatoid Arthritis
• Interventions: Device: GMK Sphere Knee Replacement

• Registration Number: NCT02199600
• Lead Sponsor: Medacta International SA

Brief Summary

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

Detailed Description

The clinical performance of the GMK® Sphere, manufactured by Medacta International, will be evaluated by a multicentre, prospective clinical surveillance study.

The Elective Orthopaedic Centre (EOC), in Epsom, Surrey, will be the study coordinating centre. Four further centres will participate in the clinical study, for five total centres. Each participating centre will recruit approximately 100 patients. Patient recruitment will cease when a cohort of 500 GMK® Sphere knee replacements have been implanted.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2014-07-07
• Study First Submitted QC: 2014-07-23
• Study First Posted: 2014-07-24
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16
• Primary Completion: 2029-10
• Study Completion: 2029-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• A disabled or severely disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis, poly-arthritis or avascular necrosis
• Patients must be between the age of 18 and 80 at the time of consent
• Listed for total knee replacement surgery.
• Patients who are willing 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 condylar structures or loss of integrity of the medial or lateral ligament
• Any patient who cannot or will not provide informed consent for participation in the study
• 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: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GMK Sphere Knee Replacement	GMK Sphere Knee Replacement	Patients who comply with the protocol and received GMK Sphere component.

Primary Outcome Measures

Name	Time	Method
Assessment of the clinical outcome following total knee replacement using the Knee Society Score.	6 months

Secondary Outcome Measures

Name	Time	Method
The EuroQol score as a measure of patient' quality of life.	pre-op, 6 months, 3, 5,7 and 10 years
Radiographic analysis	pre-op, 6 months, 3, 5,7 and 10 years.
Assessment of implant survivorship as a measure of safety and tolerability.	6 weeks, 6 months, 3, 5, 7 and 10 years.
The OXFORD score as a measure of implant functionality.	pre-op, 6 months and annually for 10 years
Assessment of the clinical outcome following total knee replacement using the Knee Society Score	pre-op, at 6 months, at 3, 5, 7 and 10 years.

Trial Locations

Locations (4)

Royal London Hospital; 🇬🇧 Whitechapel, London, United Kingdom

AZ Maria Middelares; 🇧🇪 Gent, Belgium

The Elective Orthopaedic Centre (EOC); 🇬🇧 Epsom, Surrey, United Kingdom

Royal National Orthopaedic Hospital NHS Trust; 🇬🇧 Stanmore, Middlesex, United Kingdom