Evaluating the safety and performance of hip implants over 10 years

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.

This study is testing how safe and effective certain hip implants are for patients who have hip replacement surgery over a period of 10 years.

Quick facts

• Study type: Observational
• Enrollment: 4500 (estimated)
• Sex: All
• Sponsor: ATF Implants (Industry-sponsored)
• Locations: 13 sites (Bordeaux and 12 other locations)
• Trial ID: NCT05044767 on ClinicalTrials.gov

What this trial studies

This observational and prospective multicenter study aims to assess the long-term performance and safety of ATF Implants and Lapé Médical devices used in total hip arthroplasty or hemiarthroplasty. The study will follow patients before and after hip replacement surgery, collecting data on complications, adverse effects, and overall implant survival over a period of 10 years. Surgeons will evaluate patients using predefined orthopedic criteria, ensuring a comprehensive understanding of the implants' effectiveness and safety. The study seeks to provide clinical evidence regarding the longevity and reliability of these hip prostheses.

Who should consider this trial

Good fit: Ideal candidates include males and females indicated for hip replacement surgery with prostheses manufactured by ATF Implants and/or Lapé médical.

Not a fit: Patients who are not indicated for hip replacement surgery or have contraindications for the specific implants may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of hip implant longevity and safety, leading to improved patient outcomes in hip replacement surgeries.

How similar studies have performed: Other studies evaluating the long-term performance of hip implants have shown success, indicating that this approach is supported by existing clinical evidence.

Eligibility 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.

Where this trial is running

Bordeaux and 12 other locations

• CHU de Bordeaux - Hôpital Pellegrin — Bordeaux, France (Not_yet_recruiting)
• Clinique des Cèdres — Cornebarrieu, France (Not_yet_recruiting)
• Centre Ostéo-Articulaire des Cèdres — Échirolles, France (Recruiting)
• Hôpital privé Drôme Ardèche — Guilherand-Granges, France (Not_yet_recruiting)
• Clinique du Croisé Laroche — Marcq-en-Barœul, France (Recruiting)
• Polyclinique Saint George — Nice, France (Not_yet_recruiting)
• Groupe Hospitalier Diaconesses Croix Saint-Simon — Paris, France (Recruiting)
• CHU de Poitiers — Poitiers, France (Recruiting)
• Clinique de l'Atlantique — Puilboreau, France (Not_yet_recruiting)
• CHU St Etienne, Hôpital Nord — Saint-Etienne, France (Not_yet_recruiting)
• Polyclinique Sainte Thérèse — Sète, France (Recruiting)
• Clinique de l'Orangerie — Strasbourg, France (Recruiting)
• Hôpital privé du Vert Galant — Tremblay-en-France, France (Not_yet_recruiting)

Study contacts

• Principal investigator: Philippe Laffargue, Pr — Clinique du Croisé Laroche
• Study coordinator: Philippe Laffargue, Pr

Conditions Arthroplasty, Hip, Replacement