Study to Evaluate the Performance and Safety of ATF Implants and Lapé Médical Devices Implanted During Hip Arthroplasty

Last updated: January 31, 2023
Sponsor: ATF Implants
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05044767
PEPS
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female indicated for hip replacement surgery with hip prosthesis manufacturedby ATF Implants and/or Lapé médical; There are different indications for hip replacement surgery. The main ones are listedbelow:
  • 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 givenpatient according to the patient's medical records and the instruction for use in force atthe time of the procedure accompanying the medical device.

Exclusion

Exclusion Criteria:

  • There are various contraindications for hip arthroplasty. The main ones are listedbelow:
  • An acute or chronic, local or systemic infection
  • Severe muscular, neurological or vascular deficiency compromising the affectedextremity
  • A bone defect or insufficient bone quality that may compromise the stability ofthe implant
  • Any concomitant disease (dysplastic coxarthrosis with extreme coxa valga, shortneck and severe varus) that may affect the function of the implant
  • Sensitivity to the material (allergy) Depending on the specificities of thedevices (size, absence/presence of a coating, material), contraindications mayvary. This information can be found in the instruction for use of the devices.

Study Design

Total Participants: 4500
Study Start date:
June 07, 2021
Estimated Completion Date:
December 31, 2032

Study 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.

Connect with a study center

  • CHU de Bordeaux - Hôpital Pellegrin

    Bordeaux, 33076
    France

    Site Not Available

  • Clinique des Cèdres

    Cornebarrieu, 31700
    France

    Site Not Available

  • Hôpital privé Drôme Ardèche

    Guilherand-Granges, 07500
    France

    Site Not Available

  • Polyclinique Bordeaux Rive Droite

    Lormont, 33310
    France

    Site Not Available

  • Clinique du Croisé Laroche

    Marcq-en-Barœul, 59700
    France

    Active - Recruiting

  • Polyclinique Saint George

    Nice, 06100
    France

    Site Not Available

  • Groupe Hospitalier Diaconesses Croix Saint-Simon

    Paris, 75020
    France

    Active - Recruiting

  • CHU de Poitiers

    Poitiers, 86000
    France

    Active - Recruiting

  • Clinique de l'Atlantique

    Puilboreau, 17138
    France

    Site Not Available

  • CHU St Etienne, Hôpital Nord

    Saint-Étienne, 42055
    France

    Site Not Available

  • Clinique de l'Orangerie

    Strasbourg, 67000
    France

    Active - Recruiting

  • Polyclinique Sainte Thérèse

    Sète, 34200
    France

    Active - Recruiting

  • Hôpital privé du Vert Galant

    Tremblay-en-France, 93290
    France

    Site Not Available

  • Centre Ostéo-Articulaire des Cèdres

    Échirolles, 38130
    France

    Active - Recruiting

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