Post-Market Clinical Follow Up for Total Knee Arthroplast... | NCT06120023

Studies
Post-Market Clinical Follow Up for Total Knee Arthroplasty System Madison

NCT06120023

Sponsor

Societe dEtude, de Recherche et de Fabrication

Status

Recruiting

Last Update Posted

Apr 22, 2026Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Knee Arthropathy

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 17, 2023Actual

Primary Completion Date

Dec 31, 2040Estimated

Completion Date

Dec 31, 2040Estimated

First Submitted Date

Oct 18, 2023

First Submission Date that Met QC Criteria

Nov 6, 2023

First Posted Date

Nov 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2026

Last Update Posted Date

Apr 22, 2026Actual

Description Module

Brief 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.

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Revision rate according to Kaplan-Meier	Assess the revision rate, whatever the cause of revision, including infection at 15 years	15 years

Secondary Outcomes

Measure	Description	Time Frame
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	From per operative period to 15 years
Adverse events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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,
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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Lydie BONNEVAY	Contact	04 72 05 60 10	+33	l.bonnevay@serf.fr
Clinical Department	Contact	04 72 05 60 10	+33	clinical@serf.fr