Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT05044767
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.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05044767
Study Brief:
Protocol Section:
NCT05044767