Clinical trial NCT02199600: The Medacta International GMK Sphere Post-Marketing Surveillance Study
Official title: The Medacta International GMK Sphere Post-Marketing Surveillance Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Arthritis
Traumatic Arthritis
Rheumatoid Arthritis
Poly-arthritis
Avascular Necrosis
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2014-07-24
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of the clinical outcome following total knee replacement using the Knee Society Score.
timeFrame: 6 months
Secondary outcomes:
measure: The OXFORD score as a measure of implant functionality.
timeFrame: pre-op, 6 months and annually for 10 years
measure: Assessment of implant survivorship as a measure of safety and tolerability.
timeFrame: 6 weeks, 6 months, 3, 5, 7 and 10 years.
measure: Radiographic analysis
timeFrame: pre-op, 6 months, 3, 5,7 and 10 years.
measure: The EuroQol score as a measure of patient' quality of life.
timeFrame: pre-op, 6 months, 3, 5,7 and 10 years
measure: Assessment of the clinical outcome following total knee replacement using the Knee Society Score
timeFrame: pre-op, at 6 months, at 3, 5, 7 and 10 years.
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Whitechapel
country: United Kingdom
facility: Royal London Hospital
state: London
city: Stanmore
country: United Kingdom
facility: Royal National Orthopaedic Hospital NHS Trust
state: Middlesex
city: Epsom
country: United Kingdom
facility: The Elective Orthopaedic Centre (EOC)
state: Surrey
Study officials:
References: