Clinical trial NCT05044767: Study to Evaluate the Performance and Safety of ATF Implants and Lapé Médical Devices Implanted During Hip Arthroplasty
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arthroplasty, Hip, Replacement
Lead sponsor: ATF Implants
Sponsor class: INDUSTRY
First posted: 2021-09-16
Enrollment: 4500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female indicated for hip replacement surgery with hip prosthesis manufactured by ATF Implants and/or Lapé médical.

Brief summary: 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.

Detailed description: 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.

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.

Primary outcomes:
measure: Long-term survival rate
timeFrame: 10 years
Secondary outcomes:
measure: hip joint function
timeFrame: before and after surgery (6 month, 2 years, 5 years, 7 years, 10 years)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux - Hôpital Pellegrin
city: Cornebarrieu
country: France
facility: Clinique des Cèdres
city: Guilherand-Granges
country: France
facility: Hôpital privé Drôme Ardèche
city: Marcq-en-Barœul
country: France
facility: Clinique du Croisé Laroche
city: Nice
country: France
facility: Polyclinique Saint George
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses Croix Saint-Simon
city: Poitiers
country: France
facility: CHU de Poitiers
city: Puilboreau
country: France
facility: Clinique de l'Atlantique
city: Saint-Étienne
country: France
facility: CHU St Etienne, Hôpital Nord
city: Strasbourg
country: France
facility: Clinique de l'Orangerie
city: Sète
country: France
facility: Polyclinique Sainte Thérèse
city: Tremblay-en-France
country: France
facility: Hôpital privé du Vert Galant
city: Échirolles
country: France
facility: Centre Ostéo-Articulaire des Cèdres
Study officials:
affiliation: Clinique du Croisé Laroche
name: Philippe Laffargue, Pr
role: PRINCIPAL_INVESTIGATOR
References: