NCT05044767

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,500

participants targeted

Target at P75+ for all trials

Timeline
81mo left

Started Jun 2021

Longer than P75 for all trials

Geographic Reach
1 country

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Jun 2021Dec 2032

Study Start

First participant enrolled

June 7, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
11.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2032

Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

11.6 years

First QC Date

September 6, 2021

Last Update Submit

January 31, 2023

Conditions

Arthroplasty, Hip, Replacement

Outcome Measures

Primary Outcomes (1)

  • Long-term survival rate

    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 Outcomes (1)

  • hip joint function

    before and after surgery (6 month, 2 years, 5 years, 7 years, 10 years)

Interventions

total hip arthroplastyDEVICE

hip replacement surgery

Also known as: hemiarthroplasty

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male or female indicated for hip replacement surgery with hip prosthesis manufactured by ATF Implants and/or Lapé médical.

You may qualify if:

  • 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
  • +2 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, 33076, France

NOT YET RECRUITING

Clinique des Cèdres

Cornebarrieu, 31700, France

NOT YET RECRUITING

Centre Ostéo-Articulaire des Cèdres

Échirolles, 38130, France

RECRUITING

Hôpital privé Drôme Ardèche

Guilherand-Granges, 07500, France

NOT YET RECRUITING

Clinique du Croisé Laroche

Marcq-en-Barœul, 59700, France

RECRUITING

Polyclinique Saint George

Nice, 06100, France

NOT YET RECRUITING

Groupe Hospitalier Diaconesses Croix Saint-Simon

Paris, 75020, France

RECRUITING

CHU de Poitiers

Poitiers, 86000, France

RECRUITING

Clinique de l'Atlantique

Puilboreau, 17138, France

NOT YET RECRUITING

CHU St Etienne, Hôpital Nord

Saint-Etienne, 42055, France

NOT YET RECRUITING

Polyclinique Sainte Thérèse

Sète, 34200, France

RECRUITING

Clinique de l'Orangerie

Strasbourg, 67000, France

RECRUITING

Hôpital privé du Vert Galant

Tremblay-en-France, 93290, France

NOT YET RECRUITING

MeSH Terms

Interventions

Arthroplasty, Replacement, HipHemiarthroplasty

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Philippe Laffargue, Pr

    Clinique du Croisé Laroche

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Laffargue, Pr

CONTACT

891650494plaffargue@yahoo.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2021

First Posted

September 16, 2021

Study Start

June 7, 2021

Primary Completion (Estimated)

December 31, 2032

Study Completion (Estimated)

December 31, 2032

Last Updated

February 1, 2023

Record last verified: 2023-01

Locations

FR(13)