ArthritisNCT02199600
The Medacta International GMK Sphere Post-Marketing Surveillance Study
A study testing GMK Sphere Knee Replacement in people with Arthritis and Traumatic Arthritis, run by Medacta International SA at 4 sites in 2 countries.
Trial summary
This is a Post-Marketing Surveillance of GMK Sphere knee prosthesis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthritis, Traumatic Arthritis, Rheumatoid Arthritis
- What is being tested?
- GMK Sphere Knee Replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Oct 2012to Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United Kingdom3 sites
The Elective Orthopaedic Centre (EOC)
Epsom, Surrey, KT18 7EG
Royal National Orthopaedic Hospital NHS Trust
Stanmore, Middlesex, HA74LP
Royal London Hospital
Whitechapel, London, E11BB
About this study
This is a Post-Marketing Surveillance of GMK Sphere knee prosthesis.
Read the 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.
- Being tested
- GMK Sphere Knee Replacement
- Medical subject headings
- Arthritis, Arthritis, Rheumatoid, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GMK Sphere Knee ReplacementDevice
| Study group | Role | What they receive |
|---|---|---|
| GMK Sphere Knee Replacement | Other | Patients who comply with the protocol and received GMK Sphere component. Receives: Device: GMK Sphere Knee Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the clinical outcome following total knee replacement using the Knee Society Score.
Measured: 6 months
Secondary outcomes (5)
The OXFORD score as a measure of implant functionality.
Measured: pre-op, 6 months and annually for 10 years
Assessment of implant survivorship as a measure of safety and tolerability.
Measured: 6 weeks, 6 months, 3, 5, 7 and 10 years.
Radiographic analysis
Measured: pre-op, 6 months, 3, 5,7 and 10 years.
The EuroQol score as a measure of patient' quality of life.
Measured: pre-op, 6 months, 3, 5,7 and 10 years
Assessment of the clinical outcome following total knee replacement using the Knee Society Score
Measured: pre-op, at 6 months, at 3, 5, 7 and 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startOct 2012
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by Medacta International SAThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199600
- Sponsor's protocol ID
- P02.014.01
- Status last verified
- Dec 2024
- First submitted
- 7 Jul 2014
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Medacta International GMK Sphere Post-Marketing Surveillance Study
- ClinicalTrials.gov ID
- NCT02199600
- Acronym / sponsor ID
- P02.014.01
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- Oct 2012 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 24 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GMK Sphere Knee Replacement | Other | Device: GMK Sphere Knee ReplacementPatients who comply with the protocol and received GMK Sphere component. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GMK Sphere Knee Replacement | Device | GMK Sphere Knee Replacement |
Primary outcome
Assessment of the clinical outcome following total knee replacement using the Knee Society Score.
Time frame: 6 months
5 secondary outcomes
The OXFORD score as a measure of implant functionality.
Time frame: pre-op, 6 months and annually for 10 years
Assessment of implant survivorship as a measure of safety and tolerability.
Time frame: 6 weeks, 6 months, 3, 5, 7 and 10 years.
Radiographic analysis
Time frame: pre-op, 6 months, 3, 5,7 and 10 years.
The EuroQol score as a measure of patient' quality of life.
Time frame: pre-op, 6 months, 3, 5,7 and 10 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
Related trials for Arthritis
Recruiting
Effect of Anti-inflammatory Diet in Rheumatoid Arthritis
Rheumatoid Arthritis
Active, not recruitingPhase 3
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
Psoriatic Arthritis
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingObservational study
Hemophagocytic Lymphohistiocytosis (HLH) Evaluation and Research of Clinical, ImmUnoLogic and TranscriptomE Study
Lymphohistiocytosis, Hemophagocytic, Secondary Hemophagocytic Lymphohistiocytosis
RecruitingPhase 4
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
Psoriatic Arthritis (PsA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GMK Sphere Knee Replacement in people with Arthritis and Traumatic Arthritis, run by Medacta International SA at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the clinical outcome following total knee replacement using the Knee Society Score. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024; AzTrials last refreshed its copy on 6 Nov 2026.