Menu
Recruiting NCT05044767

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

— Observational Arthroplasty, Hip, Replacement

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: total hip arthroplasty.
Who it may be relevant to
Registry conditions: Arthroplasty, Hip, Replacement. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Overview

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.

Interventions

  • Device total hip arthroplasty
    hip replacement surgery

Primary outcome measures

  • Long-term survival rate [Time frame: 10 years]
Secondary outcome measures (1)
  • hip joint function [Time frame: before and after surgery (6 month, 2 years, 5 years, 7 years, 10 years)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 13 centers
  • CHU de Bordeaux - Hôpital Pellegrin — Bordeaux
  • Clinique des Cèdres — Cornebarrieu
  • Centre Ostéo-Articulaire des Cèdres — Échirolles
  • Hôpital privé Drôme Ardèche — Guilherand-Granges
  • Clinique du Croisé Laroche — Marcq-en-Barœul
  • Polyclinique Saint George — Nice
  • Groupe Hospitalier Diaconesses Croix Saint-Simon — Paris
  • CHU de Poitiers — Poitiers
  • … and 5 more centers

Identifiers

NCT: NCT05044767 · PEPS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗