ArthropathyNCT05459948
The Medacta GMK SpheriKA Post-Marketing Surveillance Study
An observational study of Arthropathy and Knee Replacement, run by Medacta International SA at 4 sites in 3 countries.
Trial summary
This is a Post-Marketing Surveillance of GMK SpheriKA knee stem prosthesis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthropathy, Knee Replacement
- What is being tested?
- GMK SpheriKA
- Type of treatment
- Medical device
- How many people
- 281 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 30 Jul 2022to May 2035
- Phase
- Observational
- 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
- Adult, Older adult
Study population: 281 participants are planned for the entire project (all sites combined). Patients requiring "GMK® SpheriKA" implanted via the kinematic alignment technique will be informed and enrolled during the preoperative visit. The study is conducted as standard of care treatment and participants will receive the same treatment and undergo the same postoperative assessments as non-participants.
Who may be able to join
- Patients willing to sign the informed consent.
- Patients able to comply with follow-up requirements, including postoperative weight-bearing restrictions and self-evaluations.
- Patients 18 - 80 years of age at the time of surgery.
- Patients requiring a primary total knee replacement (on label use).
- Patients with intact collateral ligaments.
Who cannot join
- Patients with inflammatory arthritis.
- Morbidly obese patients, with a body mass index (BMI) > 40.
- Patients with a history of total or unicompartmental reconstruction of the affected joint.
- Patients that have had a high tibial osteotomy or femoral osteotomy.
- Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
- Patients with a systemic or metabolic disorder leading to progressive bone deterioration.
Show all 10Show fewer
- Patients that are immunologically compromised or receiving chronic steroids (> 30 days).
- Patients whose bone stock is compromised due to disease or infection, unable to provide adequate support and/or fixation to the prosthesis.
- Patients with an active or suspected latent infection in or surrounding the knee joint.
- Pregnant or breastfeeding women.
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
France2 sites, 2 recruiting
- Recruiting
Centre de l'Arthrose
Mérignac
Charles RIVIERE
- Recruiting
Clinique de l'Union
Saint-Jean, 31240
David BENZAQUEN, Dr., +33 05 61 37 87 79, davidbenzaquen@icloud.com
Switzerland1 site, 1 recruiting
- Recruiting
Gelenkzentrum Winterthur
Winterthur
Peter Koch
About this study
Official title: Medacta GMK® SpheriKA and Kinematic Alignment Technique Multicenter, Post-Market Outcome Study
This is a Post-Marketing Surveillance of GMK SpheriKA knee stem prosthesis.
Read the detailed description
The aim of the current study is to collect clinical and radiological data to monitor the performances of the "GMK® SpheriKA" Knee Prosthesis implanted via the kinematic alignment technique.
- Conditions
- Arthropathy, Knee Replacement
- Being tested
- GMK SpheriKA
- Medical subject headings
- Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GMK SpheriKADevice
The first objective is to study the FJS of patients who were implanted a "GMK® SpheriKA" knee prosthesis using the kinematic alignment technique
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective will be evaluated with the Forgotten Joint score (FJS).
study the efficacy of the treatment to make the patient forget the presence of the artificial joint in everyday life.
The Forgotten Joint Score assessment consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities
Measured: 6 weeks, from 1 to 10 years annually
Secondary outcomes (6)
patient-reported outcomes 1
Oxford Knee Score: The OKS is a patient reported outcome measure that consists of 12 questions about an individual's level of function, activities of daily living and how they have been affected by pain over the preceding four weeks
Measured: 6 weeks, from 1 to 10 years annually
Satisfaction and Expectations questionaires
Satisfaction and Expectations questionaires
Patient reported satisfaction and expectations answering some questions of the "satisfaction and expectation knee society score", the goal is to collect all final answers and have an overview on how the patient feels.
"Patient Expectations" is a three-question fifteen-point scale that is collected pre-operatively and post-operatively.
"Patient Satisfaction" is a five-question 40-point scale that is collected preoperatively and at each follow-up visit.
Measured: 6 weeks, from 1 to 10 years annually
Radiological outcomes
Radiological assessment including implant positioning, presence of radiolucent lines, subsidence, migration of components, presence of heterotopic ossifications or osteolysis
Measured: pre-op, 6weeks, 1, 2,5,10 years
Adverse events
Adverse events (type of complications, dependent or not from the device etc)
Measured: during surgical operation, 6weeks, 1,2,5,10 years
Limb alignment
Limb alignment will be measured: mMPTA (°), mLDFA (°) and joint line (HKA) will be recorded.
HKA = Hip-Knee-ankle angle measured in degrees mMPTA = mechanical medial proximal tibial angle measured in degrees mLDFA = mechanical lateral distal femoral angle measured in degrees
Measured: on preoperative and 6-week x-rays
Lateral uncoverage of the anterior femoral resection
Measurement of the lateral uncoverage of the anterior femoral resection measured in mm
Measured: During Surgical Operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start30 Jul 2022
- Primary completionMay 2035 (estimated)
- Study completionMay 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthropathyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 281 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
- NCT05459948
- Sponsor's protocol ID
- P.02.025.02
- Status last verified
- Mar 2025
- First submitted
- 7 Jul 2022
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medacta GMK® SpheriKA and Kinematic Alignment Technique Multicenter, Post-Market Outcome Study
- ClinicalTrials.gov ID
- NCT05459948
- Acronym / sponsor ID
- P.02.025.02
- Conditions
- Arthropathy, Knee Replacement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 281 participants (estimated)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2022 (actual)
- Primary completion
- May 2035 (estimated)
- Study completion
- May 2035 (estimated)
- First posted
- 15 Jul 2022 (actual)
- 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 SpheriKA knee stem prosthesis.
Detailed description
The aim of the current study is to collect clinical and radiological data to monitor the performances of the "GMK® SpheriKA" Knee Prosthesis implanted via the kinematic alignment technique.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 281 participants are planned for the entire project (all sites combined). Patients requiring "GMK® SpheriKA" implanted via the kinematic alignment technique will be informed and enrolled during the preoperative visit. The study is conducted as standard of care treatment and participants will receive the same treatment and undergo the same postoperative assessments as non-participants.
Key inclusion criteria (5 listed)
- Patients willing to sign the informed consent.
- Patients able to comply with follow-up requirements, including postoperative weight-bearing restrictions and self-evaluations.
- Patients 18 - 80 years of age at the time of surgery.
- Patients requiring a primary total knee replacement (on label use).
- Patients with intact collateral ligaments.
Key exclusion criteria (10 listed)
- Patients with inflammatory arthritis.
- Morbidly obese patients, with a body mass index (BMI) > 40.
- Patients with a history of total or unicompartmental reconstruction of the affected joint.
- Patients that have had a high tibial osteotomy or femoral osteotomy.
- Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
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 SpheriKAThe first objective is to study the FJS of patients who were implanted a "GMK® SpheriKA" knee prosthesis using the kinematic alignment technique | Device | – |
Primary outcome
Primary objective will be evaluated with the Forgotten Joint score (FJS).
Time frame: 6 weeks, from 1 to 10 years annually
study the efficacy of the treatment to make the patient forget the presence of the artificial joint in everyday life. The Forgotten Joint Score assessment consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities
6 secondary outcomes
patient-reported outcomes 1
Time frame: 6 weeks, from 1 to 10 years annually
Satisfaction and Expectations questionaires
Time frame: 6 weeks, from 1 to 10 years annually
Radiological outcomes
Time frame: pre-op, 6weeks, 1, 2,5,10 years
Adverse events
Time frame: during surgical operation, 6weeks, 1,2,5,10 years
Limb alignment
Time frame: on preoperative and 6-week x-rays
Lateral uncoverage of the anterior femoral resection
Time frame: During Surgical Operation
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 29 Sep 2025.
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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.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthropathy and Knee Replacement, run by Medacta International SA at 4 sites in 3 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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 29 Sep 2025. 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 France, Italy, Switzerland. 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?
Contact Arianna Girardi (+41 91 696 60 60, girardi@medacta.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary objective will be evaluated with the Forgotten Joint score (FJS). (time frame: 6 weeks, from 1 to 10 years annually). 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 29 Sep 2025.