Recruiting

Observational and Prospective Multicenter Study to Evaluate the Long-term (10 Years) Performance and Safety (10 Years) of ATF Implants and Lapé Médical Devices Implanted During Total Hip Arthroplasty or Hemiarthroplasty.

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: June 2021
See protocol details

Summary

Principal SponsorATF Implants
Study ContactPhilippe Laffargue, Pr
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 7, 2021

Actual date on which the first participant was enrolled.

Observational and prospective multicenter study to evaluate the long-term (10 years) performance and safety (10 years) of ATF Implants and Lapé Médical devices implanted during total hip arthroplasty or hemiarthroplasty. The post-market clinical follow-up study to be conducted by ATF Implants following this plan aims to collect data from the follow-up of patients before and after hip replacement surgery with implants manufactured by ATF Implants and Lapé médical. In current practice, the surgeon-investigator evaluates the patient pre- and post-operatively according to predefined criteria used in orthopedic surgery and more particularly in hp replacement surgery. Complications and adverse effects observed are also recorded. The main objective is to gather clinical evidence to evaluate the survival rate of ATP Implants and Lapé médical hip prostheses over the long-term, namely 10 years. The secondary objectives are to evaluate the performance and safety of the prostheses over the same period (i.e. 10 years), as well as to obtain feedback on the performance /intended use and safety of the surgical instruments required for implant placement.

Official TitleObservational and Prospective Multicenter Study to Evaluate the Long-term (10 Years) Performance and Safety (10 Years) of ATF Implants and Lapé Médical Devices Implanted During Total Hip Arthroplasty or Hemiarthroplasty.
Principal SponsorATF Implants
Study ContactPhilippe Laffargue, Pr
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

4500 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: * Male or female indicated for hip replacement surgery with hip prosthesis manufactured by ATF Implants and/or Lapé médical; There are different indications for hip replacement surgery. The main ones are listed below: * Dysplasia * Primary Coxarthrosis * Secondary Coxarthrosis * Perthes disease * Epiphysiolysis * Ankylosing spondylitis * Trochanteric bursitis * Arthritis * Degenerative arthritis * Post-traumatic arthritis * Rheumatoid arthritis * Femoral neck fracture * Osteonecrosis * Revision Depending on the specificities of the devices (size, absence/presence of a coating, material), indications may vary. This information can be found in the instruction for use. It is the surgeon's responsibility to select the most appropriate prosthesis for a given patient according to the patient's medical records and the instruction for use in force at the time of the procedure accompanying the medical device. Exclusion Criteria: * There are various contraindications for hip arthroplasty. The main ones are listed below: * An acute or chronic, local or systemic infection * Severe muscular, neurological or vascular deficiency compromising the affected extremity * A bone defect or insufficient bone quality that may compromise the stability of the implant * Any concomitant disease (dysplastic coxarthrosis with extreme coxa valga, short neck and severe varus) that may affect the function of the implant * Sensitivity to the material (allergy) Depending on the specificities of the devices (size, absence/presence of a coating, material), contraindications may vary. This information can be found in the instruction for use of the devices.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 13 locations

Recruiting

Centre Ostéo-Articulaire des Cèdres

Échirolles, FranceOpen Centre Ostéo-Articulaire des Cèdres in Google Maps
Recruiting

Clinique du Croisé Laroche

Marcq-en-Barœul, France
Recruiting

Groupe Hospitalier Diaconesses Croix Saint-Simon

Paris, France
Recruiting

CHU de Poitiers

Poitiers, France
Recruiting
13 Study Centers