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

January 31, 2023 updated by: ATF Implants

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.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

4500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bordeaux, France, 33076
        • Not yet recruiting
        • CHU de Bordeaux - Hôpital Pellegrin
        • Contact:
        • Principal Investigator:
          • Vincent Souillac, Dr
      • Cornebarrieu, France, 31700
        • Not yet recruiting
        • Clinique des Cèdres
        • Contact:
        • Principal Investigator:
          • Jonathan Hourtal, Dr
      • Guilherand-Granges, France, 07500
        • Not yet recruiting
        • Hôpital Privé Drôme Ardèche
        • Contact:
        • Principal Investigator:
          • Richard Philippe, Dr
      • Marcq-en-Barœul, France, 59700
        • Recruiting
        • Clinique du Croisé Laroche
        • Contact:
        • Principal Investigator:
          • Philippe Laffargue, Prof
      • Nice, France, 06100
        • Not yet recruiting
        • Polyclinique Saint George
        • Contact:
        • Principal Investigator:
          • Hervé Ovadia, Dr
      • Paris, France, 75020
        • Recruiting
        • Groupe Hospitalier Diaconesses Croix Saint-Simon
        • Contact:
        • Principal Investigator:
          • Simon Marmor, Dr
      • Poitiers, France, 86000
        • Recruiting
        • Chu de Poitiers
        • Contact:
        • Principal Investigator:
          • Pierre Bouget, Dr
      • Puilboreau, France, 17138
        • Not yet recruiting
        • Clinique de l'Atlantique
        • Contact:
        • Principal Investigator:
          • Cédric Bouquet, Dr
      • Saint-Étienne, France, 42055
        • Not yet recruiting
        • CHU St Etienne, Hôpital Nord
        • Contact:
        • Principal Investigator:
          • Frédéric Farizon, Dr
      • Strasbourg, France, 67000
        • Recruiting
        • Clinique de l'Orangerie
        • Contact:
        • Principal Investigator:
          • David Dagrenat, Dr
      • Sète, France, 34200
        • Recruiting
        • Polyclinique Sainte Thérèse
        • Contact:
        • Principal Investigator:
          • François Lozach, Dr
      • Tremblay-en-France, France, 93290
        • Not yet recruiting
        • Hôpital privé du Vert Galant
        • Contact:
        • Principal Investigator:
          • Faouzi Madi, Dr
      • Échirolles, France, 38130
        • Recruiting
        • Centre Ostéo-Articulaire des Cèdres
        • Contact:
        • Principal Investigator:
          • Jean-Claude Panisset, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

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

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term survival rate
Time Frame: 10 years
Long-term survival rate of the prostheses (10 years) with failure defined as revision surgery when considering all causes using Kaplan-Meier method.
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hip joint function
Time Frame: before and after surgery (6 month, 2 years, 5 years, 7 years, 10 years)
The evolution of hip joint function, and in this case the degree of physical disability before and after an intervention with Merle d'Aubigné score (PMA score) or Harris Hip Score (HHS score) or Parker score
before and after surgery (6 month, 2 years, 5 years, 7 years, 10 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ATF Implants

Investigators

  • Principal Investigator: Philippe Laffargue, Pr, Clinique du Croisé Laroche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2021

Primary Completion (Anticipated)

December 31, 2032

Study Completion (Anticipated)

December 31, 2032

Study Registration Dates

First Submitted

September 6, 2021

First Submitted That Met QC Criteria

September 6, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Actual)

February 1, 2023

Last Update Submitted That Met QC Criteria

January 31, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • PEPS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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