2022-07: Post-Market Clinical Follow Up for Total Knee Arthroplasty System Madison

Sponsor

Societe dEtude, de Recherche et de Fabrication (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06120023

Collaborator

(none)

1,000

Enrollment

Location

206.5

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Arthropathy

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 17, 2023

Anticipated Primary Completion Date :

Dec 31, 2040

Anticipated Study Completion Date :

Dec 31, 2040

Outcome Measures

Primary Outcome Measures

Revision rate according to Kaplan-Meier [15 years]
Assess the revision rate, whatever the cause of revision, including infection at 15 years

Secondary Outcome Measures

Survival rate according to Kaplan-Meier [From per operative period to 15 years]
Assess the survival rate, whatever the cause of revision, including infection at 1 year, 3 years, 5 years and 10 years follow-up
Adverse events [From per operative period to 15 years]
List type and occurence of adverse events
Functional improvement using 2011KSS score [From per operative period to 15 years]
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).
Patient's expectation / satisfaction using 2011KSS score [From per operative period to 15 years]
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).
Pain reduction using 2011KSS score [From per operative period to 15 years]
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).
Pain Evaluation using KOOS [From per operative period to 15 years]
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)
Functional improvement in Daily Living using KOOS [From per operative period to 15 years]
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)
Functional improvement in Sport and Recreation using KOOS [From per operative period to 15 years]
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)
Functional improvement Other Symptoms using KOOS [From per operative period to 15 years]
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)
Assessement of Knee-Related Quality of Life using KOOS [From per operative period to 15 years]
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)
Oblivion of prosthesis [From per operative period to 15 years]
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.
Mobility improvement [From per operative period to 15 years]
Assessed by the surgeon through questionary with a 4 item-scale : significant improvement / slight improvement / identical mobility / decrease of mobility

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinique de la Sauvegarde	Lyon	Rhône	France	69009

Sponsors and Collaborators

Societe dEtude, de Recherche et de Fabrication

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Societe dEtude, de Recherche et de Fabrication

ClinicalTrials.gov Identifier:

NCT06120023

Other Study ID Numbers:

2022-07_Madison3

First Posted:

Nov 7, 2023

Last Update Posted:

Nov 7, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Societe dEtude, de Recherche et de Fabrication

total knee prosthesis

Additional relevant MeSH terms:

Joint Diseases

Study Results

No Results Posted as of Nov 7, 2023