H-35 CL TRAUMA Cemented Femoral Stem

Limacorporate

Status: Completed

Conditions: Arthroplasty; Replacement; Hip

Treatments: Device: CL TRAUMA femoral stem

Study type: Observational

Funder types: Industry

Identifiers

NCT05606120

H-35

Details and patient eligibility

About

Study design: monocentric, retrospective, observational and post-market clinical study.

Purpose: To demonstrate the safety and performance of CL TRAUMA femoral stem. The eligible study population is represented by the entire population that underwent a hip replacement with CL TRAUMA femoral stem from 2017 to 2023 at Azienda Ospedaliera di Padova (IT) in accordance with the indication for use of the product.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

54 participants in 1 patient group

CL TRAUMA implanted patients

Description:

Patients who underwent hip arthroplasty with CL TRAUMA cemented femoral stem from 2017 to 2023.

Treatment:

Device: CL TRAUMA femoral stem