The Medacta International GMK Sphere Post-Marketing Surveillance Study

Rheumatoid Arthritis Clinical Trial

Official title:

The Medacta International GMK Sphere Post-Marketing Surveillance Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02199600
• Other study ID #: P02.014.01
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2012
• Est. completion date: October 2029

Study information

• Verified date: December 2023
• Source: Medacta International SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: October 2029
• Est. primary completion date: October 2029
• 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 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

Related Conditions & MeSH terms

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

Intervention

Device:
• GMK Sphere Knee Replacement

Locations

Country	Name	City	State
Belgium	AZ Maria Middelares	Gent
United Kingdom	The Elective Orthopaedic Centre (EOC)	Epsom	Surrey
United Kingdom	Royal National Orthopaedic Hospital NHS Trust	Stanmore	Middlesex
United Kingdom	Royal London Hospital	Whitechapel	London

Sponsors (1)

Lead Sponsor	Collaborator
Medacta International SA

Countries where clinical trial is conducted

Belgium,  United Kingdom, 

Outcome

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