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 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT05606120
Eligibility Criteria:
Inclusion Criteria:
1. Male or female;
2. Age \> 18 years old;
3. All patients must give written informed consent approved by the study site's Institutional Review Board (IRB)/Ethical Committee (EC);
4. Adult patients in whom a decision has already been made to perform a partial or total hip arthroplasty with CL TRAUMA femoral stem as per indication for use. The decision to implant CL TRAUMA must be taken prior to, and independently from the decision to enroll the patient. This decision should be made in accordance with routine clinical practice at the study site concerned;
5. Patients suffering from: non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and dysplasia; or suffering from rheumatoid arthritis; or patients requiring treatment of femoral head and neck fractures;
6. Patients able to comply with the protocol.
Exclusion Criteria:
1. Adult patients with any CL TRAUMA femoral stem contraindication for use as reported in the current local Instruction for use;
2. Patients with active or any suspected infection (on the affected hip or systemic);
3. Patients suffering from acute or chronic osteomyelitis;
4. Patients with confirmed nerve or muscle lesion compromising hip joint function;
5. Patients with vascular or nerve diseases affecting the concerned limb;
6. Patients with poor bone stock (such as osteoporosis or extended previous revision surgery) compromising the stability of the implant;
7. Patients with metabolic disorders which may impair fixation and stability of the implant;
8. Any concomitant disease and dependence that might affect the implanted prosthesis;
9. Patients with known incompatibility or allergy to the product materials, and/or metal hypersensitivity to implant materials;
10. Patients currently participating in any other surgical intervention studies or pain management studies;
11. Female patients who are pregnant, nursing or planning a pregnancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05606120
Study Brief:
Protocol Section:
NCT05606120