Total Knee ArthroplastyNCT06578897
A Post-Market, Retrospective Study on 3D Metal Tibial and Femoral Cones
An observational study of Total Knee Arthroplasty, run by Medacta International SA at 1 site in United States.
Trial summary
GMK Revision Knee System is part of the Medacta GMK® (Global Medacta Knee) Total Knee System and is indicated when a higher level of varus/valgus constraint is needed. The external shape of the GMK® Revision femoral component is identical to that of GMK® Primary. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- 3D Metal Tibial and Femoral cones
- Type of treatment
- Medical device
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2024to 13 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The total expected number of subjects to be included in this study is a minimum number of 50. This number has been estimated according to the number of surgeries that have been performed and is considered in-line with observational studies published in literature.
Who may be able to join
- Subjects underwent revision total knee replacement for any type of etiology (Osteoarthritis, Avascular necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis, Polyarthritis, Primary implantation failure, Infection, Ligamentous Instability)
- Subjects must have received a Medacta GMK Revision component using 3D metal tibial and femoral cones
- Must be at minimum 1 year (12 months) post-treatment
- No age limit criteria
Who cannot join
- Subjects with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device
- Subjects that were incarcerated at the time of surgery.
- History of alcoholism
- On chemotherapy or radiation therapy during the time of interest
- Habitual use of narcotic pain medications prior to surgery or after surgery for reasons other than knee pain
- History of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis
Show all 10Show fewer
- History of chronic pain issues for reasons other than knee pain
- Progressive local or systemic infection during time of interest
- Muscular loss, neuromuscular disease, or vascular deficiency of the affected limb
- Obesity or excessive weight of subject
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Post-Market, Retrospective Study to Collect Clinical Outcomes From Patients Who Have Undergone Revision Total Knee Arthroplasty Using Medacta GMK Revision With 3D Metal Tibial and Femoral Cones.
GMK Revision Knee System is part of the Medacta GMK® (Global Medacta Knee) Total Knee System and is indicated when a higher level of varus/valgus constraint is needed. The external shape of the GMK® Revision femoral component is identical to that of GMK® Primary. The GMK® Revision differs from GMK® Primary by three important design features:
- The addition of a box which allows a stem to be inserted into the femoral canal; ii. The addition of screw lugs so that augments can be placed on the distal and posterior resections, and; iii. The box which also allows various levels of constraint to be added to the polyethylene insert. The tibial component offers the ability to place augments.
Read more
Indications for Use:
The GMK® Total Knee System is designed for cemented use in total knee arthroplasty if there is evidence of sufficient sound bone to seat and support the components.
This knee replacement system is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis
- Avascular necrosis of femoral condyle
- Post traumatic loss of joint configuration
- Primary implantation failure
- Ligamentous Instability
Tibial augments are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral component.
GMK® Revision femoral components are manufactured of Cobalt Chromium Molybdenum (CoCrMo) according to ISO 5832-4:1996, Implants for Surgery- Metallic materials - Part 4: Cobalt-Chromium-Molybdenum Casting Alloy, the same as the GMK® Primary femoral components. They have an asymmetric patellar groove (left and right) with different radii of curvature in coronal plane as well as non-parallel anterior and posterior cuts (wedge shape). The GMK® Revision posterior stabilized femoral components are designed for use without cruciate ligaments when additional stability is required to prevent subluxation of the femur to the tibia in flexion, same as the GMK® Primary femoral components.
In case of severe bone loss, the tibial cones and femoral cones may be used to respectively reinforce the proximal tibia cavity and the distal femoral cavity, providing structural support and load redistribution on the remaining bone. Being an integral part of revision TKA for patients with such bone loss, the clinical outcomes for revision TKAs using the cone components are important for the knowledge regarding performance and survivorship of the Revision TKA as a whole.
- Conditions
- Total Knee Arthroplasty
- Being tested
- 3D Metal Tibial and Femoral cones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Metal Tibial and Femoral conesDevice
- To collect retrospective clinical outcomes and data on revision TKAs using Medacta GMK Revision with 3D metal tibial and femoral cones
- Evaluate the patient reported functionality of the operated knee
- Evaluate the clinical and radiological performance
- Evaluate safety of the cones
- Evaluate survivorship of revisions using tibial and femoral cones
What is being measured
The primary outcome is the main question the study is designed to answer.
To collect retrospective clinical outcomes and data on revision TKAs using Medacta GMK Revision with 3D metal tibial and femoral cones
Oxford Knee Score (OKS) is a 12-item patient-reported PRO specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty).
The overall score for the OKS is acquired by simply summing the scores received for individual questions. This results in a continuous score ranging from 0 (most severe symptoms/problems) to 48 (least severe).
Measured: 1 year
To collect retrospective clinical outcomes and data on revision TKAs using Medacta GMK Revision with 3D metal tibial and femoral cones
Forgotten Joint Score (FJS) is a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint.
The FJS responses "never," "almost never," "seldom," "sometimes," and "mostly" translate into a 5-point Likert-response format translated linearly into a summative range from 0 to 100 scale with high values translating to the patient successfully "forgetting" about their joint during activities of daily living
Measured: 1 year
To collect retrospective clinical outcomes and data on revision TKAs using Medacta GMK Revision with 3D metal tibial and femoral cones
Knee Injury and Osteoarthritis Outcome Score (KOOS) s a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury.
Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures.
Measured: 1 year
Secondary outcomes (3)
Evaluate the clinical and radiological performance
standard x-ray exam performed preoperatively and postoperatively before discharge from hospital and during follow-up visits
Measured: 1 year
Evaluate safety of the cones
Any complication occurred during the study
Measured: through study completion, an average of 1 year
Evaluate survivorship of revisions using tibial and femoral cones
% survival rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start13 Feb 2024
- Primary completion13 Feb 2025
- Study completion13 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- Retrospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578897
- Sponsor's protocol ID
- MUSA-CONES1-2023
- Status last verified
- Sep 2025
- First submitted
- 21 Aug 2024
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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
- A Post-Market, Retrospective Study to Collect Clinical Outcomes From Patients Who Have Undergone Revision Total Knee Arthroplasty Using Medacta GMK Revision With 3D Metal Tibial and Femoral Cones.
- ClinicalTrials.gov ID
- NCT06578897
- Acronym / sponsor ID
- MUSA-CONES1-2023
- Conditions
- Total Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- 13 Feb 2025 (actual)
- Study completion
- 13 Feb 2025 (actual)
- First posted
- 30 Aug 2024 (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.
GMK Revision Knee System is part of the Medacta GMK® (Global Medacta Knee) Total Knee System and is indicated when a higher level of varus/valgus constraint is needed. The external shape of the GMK® Revision femoral component is identical to that of GMK® Primary. The GMK® Revision differs from GMK® Primary by three important design features:
- The addition of a box which allows a stem to be inserted into the femoral canal; ii. The addition of screw lugs so that augments can be placed on the distal and posterior resections, and; iii. The box which also allows various levels of constraint to be added to the polyethylene insert. The tibial component offers the ability to place augments.
Indications for Use:
The GMK® Total Knee System is designed for cemented use in total knee arthroplasty if there is evidence of sufficient sound bone to seat and support the components.
This knee replacement system is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis
- Avascular necrosis of femoral condyle
- Post traumatic loss of joint configuration
- Primary implantation failure
- Ligamentous Instability
Tibial augments are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral component.
GMK® Revision femoral components are manufactured of Cobalt Chromium Molybdenum (CoCrMo) according to ISO 5832-4:1996, Implants for Surgery- Metallic materials - Part 4: Cobalt-Chromium-Molybdenum Casting Alloy, the same as the GMK® Primary femoral components. They have an asymmetric patellar groove (left and right) with different radii of curvature in coronal plane as well as non-parallel anterior and posterior cuts (wedge shape). The GMK® Revision posterior stabilized femoral components are designed for use without cruciate ligaments when additional stability is required to prevent subluxation of the femur to the tibia in flexion, same as the GMK® Primary femoral components.
In case of severe bone loss, the tibial cones and femoral cones may be used to respectively reinforce the proximal tibia cavity and the distal femoral cavity, providing structural support and load redistribution on the remaining bone. Being an integral part of revision TKA for patients with such bone loss, the clinical outcomes for revision TKAs using the cone components are important for the knowledge regarding performance and survivorship of the Revision TKA as a whole.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The total expected number of subjects to be included in this study is a minimum number of 50. This number has been estimated according to the number of surgeries that have been performed and is considered in-line with observational studies published in literature.
Key inclusion criteria (4 listed)
- Subjects underwent revision total knee replacement for any type of etiology (Osteoarthritis, Avascular necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis, Polyarthritis, Primary implantation failure, Infection, Ligamentous Instability)
- Subjects must have received a Medacta GMK Revision component using 3D metal tibial and femoral cones
- Must be at minimum 1 year (12 months) post-treatment
- No age limit criteria
Key exclusion criteria (10 listed)
- Subjects with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device
- Subjects that were incarcerated at the time of surgery.
- History of alcoholism
- On chemotherapy or radiation therapy during the time of interest
- Habitual use of narcotic pain medications prior to surgery or after surgery for reasons other than knee pain
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 |
|---|---|---|
| 3D Metal Tibial and Femoral cones* To collect retrospective clinical outcomes and data on revision TKAs using Medacta GMK Revision with 3D metal tibial and femoral cones * Evaluate the patient reported functionality of the operated knee * Evaluate the clinical and radiological performance * Evaluate safety of the cones * Evaluate survivorship of revisions using tibial and femoral cones | Device | – |
Primary outcome
To collect retrospective clinical outcomes and data on revision TKAs using Medacta GMK Revision with 3D metal tibial and femoral cones
Time frame: 1 year
Oxford Knee Score (OKS) is a 12-item patient-reported PRO specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty). The overall score for the OKS is acquired by simply summing the scores received for individual questions. This results in a continuous score ranging from 0 (most severe symptoms/problems) to 48 (least severe).
To collect retrospective clinical outcomes and data on revision TKAs using Medacta GMK Revision with 3D metal tibial and femoral cones
Time frame: 1 year
Forgotten Joint Score (FJS) is a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint. The FJS responses "never," "almost never," "seldom," "sometimes," and "mostly" translate into a 5-point Likert-response format translated linearly into a summative range from 0 to 100 scale with high values translating to the patient successfully "forgetting" about their joint during activities of daily living
To collect retrospective clinical outcomes and data on revision TKAs using Medacta GMK Revision with 3D metal tibial and femoral cones
Time frame: 1 year
Knee Injury and Osteoarthritis Outcome Score (KOOS) s a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures.
3 secondary outcomes
Evaluate the clinical and radiological performance
Time frame: 1 year
Evaluate safety of the cones
Time frame: through study completion, an average of 1 year
Evaluate survivorship of revisions using tibial and femoral cones
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Arthroplasty, run by Medacta International SA at 1 site in United States.
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 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: finished, 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 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To collect retrospective clinical outcomes and data on revision TKAs using Medacta GMK Revision with 3D metal tibial and femoral cones (time frame: 1 year). The study lists 3 primary outcomes in all. 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.