Back to resultsThe Medacta International GMK Sphere Post-Marketing Surveillance Study
Primary Purpose
Arthritis, Traumatic Arthritis, Rheumatoid Arthritis
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
GMK Sphere Knee Replacement
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis
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
Sites / Locations
- AZ Maria Middelares
- Royal London Hospital
- Royal National Orthopaedic Hospital NHS Trust
- The Elective Orthopaedic Centre (EOC)
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
GMK Sphere Knee Replacement
Arm Description
Patients who comply with the protocol and received GMK Sphere component.
Outcomes
Primary Outcome Measures
Assessment of the clinical outcome following total knee replacement using the Knee Society Score.
Secondary Outcome Measures
The OXFORD score as a measure of implant functionality.
Assessment of implant survivorship as a measure of safety and tolerability.
Radiographic analysis
The EuroQol score as a measure of patient' quality of life.
Assessment of the clinical outcome following total knee replacement using the Knee Society Score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02199600
Brief Title
The Medacta International GMK Sphere Post-Marketing Surveillance Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2012 (Actual)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
April 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medacta International SA
4. Oversight
5. Study Description
Brief Summary
This is a Post-Marketing Surveillance of GMK Sphere knee prosthesis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Traumatic Arthritis, Rheumatoid Arthritis, Poly-arthritis, Avascular Necrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GMK Sphere Knee Replacement
Arm Type
Other
Arm Description
Patients who comply with the protocol and received GMK Sphere component.
Intervention Type
Device
Intervention Name(s)
GMK Sphere Knee Replacement
Primary Outcome Measure Information:
Title
Assessment of the clinical outcome following total knee replacement using the Knee Society Score.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The OXFORD score as a measure of implant functionality.
Time Frame
pre-op, 6 months and annually for 10 years
Title
Assessment of implant survivorship as a measure of safety and tolerability.
Time Frame
6 weeks, 6 months, 3, 5, 7 and 10 years.
Title
Radiographic analysis
Time Frame
pre-op, 6 months, 3, 5,7 and 10 years.
Title
The EuroQol score as a measure of patient' quality of life.
Time Frame
pre-op, 6 months, 3, 5,7 and 10 years
Title
Assessment of the clinical outcome following total knee replacement using the Knee Society Score
Time Frame
pre-op, at 6 months, at 3, 5, 7 and 10 years.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
AZ Maria Middelares
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Royal London Hospital
City
Whitechapel
State/Province
London
ZIP/Postal Code
E11BB
Country
United Kingdom
Facility Name
Royal National Orthopaedic Hospital NHS Trust
City
Stanmore
State/Province
Middlesex
ZIP/Postal Code
HA74LP
Country
United Kingdom
Facility Name
The Elective Orthopaedic Centre (EOC)
City
Epsom
State/Province
Surrey
ZIP/Postal Code
KT18 7EG
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
The Medacta International GMK Sphere Post-Marketing Surveillance Study
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