Knee Arthropathy2022-07NCT06120023
Post-Market Clinical Follow Up for Total Knee Arthroplasty System Madison
An observational study of Knee Arthropathy, run by Societe dEtude, de Recherche et de Fabrication at 1 site in France.
Trial summary
MADISON Total Knee Prosthesis is intended to be used for total knee arthroplasty to reduce pain and restore joint mobility of the knee. Clinical data for MADISON Total Knee Prosthesis available are not deemed sufficient to support performance and benefits claimed on the whole lifetime of the product. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthropathy
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 17 Oct 2023to 31 Dec 2040
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects with a diagnosis of knee replacement surgery requiring to be implanted with a TKA (Total Knee Arthroplasty) system MADISON according to instructions for use. Patients will be followed according to current practice.
Who may be able to join
- Male or female adults (≥ 18 years) covered by French social security system
- Diagnosed with:
- Osteoarthritis (primary and secondary),
- Revision of a unicompartmental knee prosthesis.
- Patient requiring a surgery and implantation of a Madison TKA (Total Knee Arthroplasty)
- Patient physically and mentally able to comply with protocol, meet the follow-up visits as deemed by the investigator and fill in quality of life questionnaire.
- Patient having signed a written informed consent
Who cannot join
- Progressive, acute or chronic infection, local to the operative site or systemic that may affect the prosthetic joint,
- Any loss of musculature or serious lesions of muscles, nerves and/or blood vessels deficiency, putting the affected limb at risk,
- Lack of bone substance or inadequate bone quality on femoral or tibial surfaces, as it might compromise the stability of the prosthesis components,
- Skeletal immaturity,
- Pathologies that may compromise the functionality of the implant in any way (i.e. osteomyelitis, neuropathic joint),
- Parameters incompatible with satisfactory long-term results (i.e. age, weight,
Show all 13Show fewer
- Neurological condition of the patient incompatible with the post-operative constraints associated with this type of intervention,
- Known allergy to one of the implant components.
- Severe obesity with or without comorbidities
- Pregnant or nursing women,
- Patients with a contraindication to radiography
- Patients deprived of their liberty or hospitalised without their consent
- Patients under legal protection (e.g. guardianship)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique de la Sauvegarde
Lyon, Rhône, 69009
About this study
MADISON Total Knee Prosthesis is intended to be used for total knee arthroplasty to reduce pain and restore joint mobility of the knee.
Clinical data for MADISON Total Knee Prosthesis available are not deemed sufficient to support performance and benefits claimed on the whole lifetime of the product.
Read more
Thus, in order to maintain compliance with the EU regulation (2017/745) related to medical devices and following ISO 14/155:2020, SERF has set up post-market clinical follow-up study (PMCF) to confirm safety and performance of Total Knee Arthroplasty system MADISON. This study is designed to cover the expected 15-years follow-up, to retrieve data according to implant feature (Posterior Stabilized or Ultra Congruent) or fixation method and to gather data related to the revision of partial knee prosthesis.
The primary objective of this study is to assess the clinical safety of MADISON total knee prostheses. The secondary objective is to evaluate the survival rates, the clinical performances and clinical benefits of MADISON total knee prosthesis.
- Conditions
- Knee Arthropathy
- Keywords
- total knee prosthesis
What is being measured
The primary outcome is the main question the study is designed to answer.
Revision rate according to Kaplan-Meier
Assess the revision rate, whatever the cause of revision, including infection at 15 years
Measured: 15 years
Secondary outcomes (12)
Survival rate according to Kaplan-Meier
Assess the survival rate, whatever the cause of revision, including infection at 1 year, 3 years, 5 years and 10 years follow-up
Measured: From per operative period to 15 years
Adverse events
List type and occurence of adverse events
Measured: From per operative period to 15 years
Functional improvement using 2011KSS score
2011 KSS stands for Knee Society Score Assessement of functional improvement picked up from global 2011KSS score. The functional score is composed of four subgroups and is rating from 0 to 100 (higher score means a better outcome).
Measured: From per operative period to 15 years
Patient's expectation / satisfaction using 2011KSS score
2011 KSS stands for Knee Society Score Evaluation of patient's expectation / satisfaction is picked up from global 2011KSS score.
This evaluation is rating from 0 to 55 (higher score means a better outcome).
Measured: From per operative period to 15 years
Pain reduction using 2011KSS score
2011 KSS stands for Knee Society Score Pain reduction evaluation is picked up from the symptom score of global 2011KSS score.
This score is rating from 0 to 25 (higher score means a better outcome).
Measured: From per operative period to 15 years
Pain Evaluation using KOOS
Evaluate pain using KOOS score. KOOS stands for Knee Injury and Osteoarthritis Outcome Score. The questionnaire has five separately scored subscales: Pain, Function in Daily Living (ADL), Function in Sport and Recreation, Other Symptoms, and Knee-Related Quality of Life (QOL).
Pain evaluation is picked up from global KOOS score. Each question is assigned a score (0-4) and a normalized score is calculated for each subscale (100 indicates no symptoms and 0 indicates extreme symptoms)
Measured: From per operative period to 15 years
Functional improvement in Daily Living using KOOS
Evaluate Function in Daily Living (ADL) using KOOS score. KOOS stands for Knee Injury and Osteoarthritis Outcome Score. The questionnaire has five separately scored subscales: Pain, Function in Daily Living (ADL), Function in Sport and Recreation, Other Symptoms, and Knee-Related Quality of Life (QOL).
Function in Daily Living (ADL) evaluation is picked up from global KOOS score. Each question is assigned a score (0-4) and a normalized score is calculated for each subscale (100 indicates no symptoms and 0 indicates extreme symptoms)
Measured: From per operative period to 15 years
Functional improvement in Sport and Recreation using KOOS
Evaluate Function in Sport and Recreation using KOOS score. KOOS stands for Knee Injury and Osteoarthritis Outcome Score. The questionnaire has five separately scored subscales: Pain, Function in Daily Living (ADL), Function in Sport and Recreation, Other Symptoms, and Knee-Related Quality of Life (QOL).
Function in Sport and Recreation evaluation is picked up from global KOOS score.
Each question is assigned a score (0-4) and a normalized score is calculated for each subscale (100 indicates no symptoms and 0 indicates extreme symptoms)
Measured: From per operative period to 15 years
Functional improvement Other Symptoms using KOOS
Evaluate Other Symptoms using KOOS score. KOOS stands for Knee Injury and Osteoarthritis Outcome Score. The questionnaire has five separately scored subscales: Pain, Function in Daily Living (ADL), Function in Sport and Recreation, Other Symptoms, and Knee-Related Quality of Life (QOL).
Other Symptoms evaluation is picked up from global KOOS score. Each question is assigned a score (0-4) and a normalized score is calculated for each subscale (100 indicates no symptoms and 0 indicates extreme symptoms)
Measured: From per operative period to 15 years
Assessement of Knee-Related Quality of Life using KOOS
Evaluate Knee-Related Quality of Life (QOL) using KOOS score. KOOS stands for Knee Injury and Osteoarthritis Outcome Score. The questionnaire has five separately scored subscales: Pain, Function in Daily Living (ADL), Function in Sport and Recreation, Other Symptoms, and Knee-Related Quality of Life (QOL).
Knee-Related Quality of Life (QOL) assessement is picked up from global KOOS score.
Each question is assigned a score (0-4) and a normalized score is calculated for each subscale (100 indicates no symptoms and 0 indicates extreme symptoms)
Measured: From per operative period to 15 years
Oblivion of prosthesis
Assess the degree of forgetfulness of the prosthesis using FJS-score (Forgotten Joint Score):
FJS stands for Forgotten Joint Score. The Forgotten Joint Score assessement consists of 12 questions and is scored on a 0-100 scale. The higher is the score, the less the patient is aware of their affected joint when performing daily activities.
Measured: From per operative period to 15 years
Mobility improvement
Assessed by the surgeon through questionary with a 4 item-scale : significant improvement / slight improvement / identical mobility / decrease of mobility
Measured: From per operative period to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start17 Oct 2023
- Primary completion31 Dec 2040 (estimated)
- Study completion31 Dec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthropathyStudies of the same condition, open and under way.
- 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Societe dEtude, de Recherche et de Fabrication
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120023
- Sponsor's protocol ID
- 2022-07_Madison3
- Acronym
- 2022-07
- Status last verified
- Apr 2026
- First submitted
- 18 Oct 2023
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Follow Up for Total Knee Arthroplasty System Madison
- ClinicalTrials.gov ID
- NCT06120023
- Acronym / sponsor ID
- 2022-07 / 2022-07_Madison3
- Conditions
- Knee Arthropathy
- Keywords
- total knee prosthesis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Societe dEtude, de Recherche et de FabricationIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 31 Dec 2040 (estimated)
- Study completion
- 31 Dec 2040 (estimated)
- First posted
- 7 Nov 2023 (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.
MADISON Total Knee Prosthesis is intended to be used for total knee arthroplasty to reduce pain and restore joint mobility of the knee.
Clinical data for MADISON Total Knee Prosthesis available are not deemed sufficient to support performance and benefits claimed on the whole lifetime of the product.
Thus, in order to maintain compliance with the EU regulation (2017/745) related to medical devices and following ISO 14/155:2020, SERF has set up post-market clinical follow-up study (PMCF) to confirm safety and performance of Total Knee Arthroplasty system MADISON. This study is designed to cover the expected 15-years follow-up, to retrieve data according to implant feature (Posterior Stabilized or Ultra Congruent) or fixation method and to gather data related to the revision of partial knee prosthesis.
The primary objective of this study is to assess the clinical safety of MADISON total knee prostheses. The secondary objective is to evaluate the survival rates, the clinical performances and clinical benefits of MADISON total knee prosthesis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects with a diagnosis of knee replacement surgery requiring to be implanted with a TKA (Total Knee Arthroplasty) system MADISON according to instructions for use. Patients will be followed according to current practice.
Key inclusion criteria (7 listed)
- Male or female adults (≥ 18 years) covered by French social security system
- Diagnosed with:
- Patient requiring a surgery and implantation of a Madison TKA (Total Knee Arthroplasty)
- Patient physically and mentally able to comply with protocol, meet the follow-up visits as deemed by the investigator and fill in quality of life questionnaire.
- Patient having signed a written informed consent
Key exclusion criteria (13 listed)
- Progressive, acute or chronic infection, local to the operative site or systemic that may affect the prosthetic joint,
- Any loss of musculature or serious lesions of muscles, nerves and/or blood vessels deficiency, putting the affected limb at risk,
- Lack of bone substance or inadequate bone quality on femoral or tibial surfaces, as it might compromise the stability of the prosthesis components,
- Skeletal immaturity,
- Pathologies that may compromise the functionality of the implant in any way (i.e. osteomyelitis, neuropathic joint),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Revision rate according to Kaplan-Meier
Time frame: 15 years
Assess the revision rate, whatever the cause of revision, including infection at 15 years
12 secondary outcomes
Survival rate according to Kaplan-Meier
Time frame: From per operative period to 15 years
Adverse events
Time frame: From per operative period to 15 years
Functional improvement using 2011KSS score
Time frame: From per operative period to 15 years
Patient's expectation / satisfaction using 2011KSS score
Time frame: From per operative period to 15 years
Pain reduction using 2011KSS score
Time frame: From per operative period to 15 years
Pain Evaluation using KOOS
Time frame: From per operative period to 15 years
Functional improvement in Daily Living using KOOS
Time frame: From per operative period to 15 years
Functional improvement in Sport and Recreation using KOOS
Time frame: From per operative period to 15 years
Functional improvement Other Symptoms using KOOS
Time frame: From per operative period to 15 years
Assessement of Knee-Related Quality of Life using KOOS
Time frame: From per operative period to 15 years
Oblivion of prosthesis
Time frame: From per operative period to 15 years
Mobility improvement
Time frame: From per operative period to 15 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 22 Apr 2026.
Related trials for Knee Arthropathy
Recruiting
Outpatient Physiotherapy vs. mHealth Exercise and Self-Management for Knee Osteoarthritis (MOKneeTOR)
Knee Osteoarthristis
Not yet recruiting
Effects of Music During Walking on Pain and Muscle Activation in People With Chronic Pain Due to Knee Osteoarthritis
Knee Osteoarthritis
Recruiting
Radio- KO Radiotherapy for Knee Osteoarthritis Clinical Trial
Osteoarthritis, Knee
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
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.
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 Knee Arthropathy, run by Societe dEtude, de Recherche et de Fabrication at 1 site in France.
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 7 inclusion and 13 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 22 Apr 2026. 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 France. 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 Lydie BONNEVAY (04 72 05 60 10 ext. +33, l.bonnevay@serf.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revision rate according to Kaplan-Meier (time frame: 15 years). 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 22 Apr 2026.