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

Sponsor

ATF Implants (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05044767

Collaborator

(none)

4,500

Enrollment

Locations

138.8

Anticipated Duration (Months)

346.2

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arthroplasty, Hip, Replacement	Device: total hip arthroplasty

Detailed Description

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

4500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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.

Actual Study Start Date :

Jun 7, 2021

Anticipated Primary Completion Date :

Dec 31, 2032

Anticipated Study Completion Date :

Dec 31, 2032

Outcome Measures

Primary Outcome Measures

Long-term survival rate [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.

Secondary Outcome Measures

hip joint function [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU de Bordeaux - Hôpital Pellegrin	Bordeaux	France	33076
2	Clinique des Cèdres	Cornebarrieu	France	31700
3	Hôpital privé Drôme Ardèche	Guilherand-Granges	France	07500
4	Polyclinique Bordeaux Rive Droite	Lormont	France	33310
5	Clinique du Croisé Laroche	Marcq-en-Barœul	France	59700
6	Polyclinique Saint George	Nice	France	06100
7	Groupe Hospitalier Diaconesses Croix Saint-Simon	Paris	France	75020
8	CHU de Poitiers	Poitiers	France	86000
9	Clinique de l'Atlantique	Puilboreau	France	17138
10	Clinique de l'Orangerie	Strasbourg	France	67000
11	Polyclinique Sainte Thérèse	Sète	France	34200
12	Hôpital privé du Vert Galant	Tremblay-en-France	France	93290
13	Centre Ostéo-Articulaire des Cèdres	Échirolles	France	38130

Sponsors and Collaborators

ATF Implants

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ATF Implants

ClinicalTrials.gov Identifier:

NCT05044767

Other Study ID Numbers:

PEPS

First Posted:

Sep 16, 2021

Last Update Posted:

Sep 16, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 16, 2021