Clinical trial NCT05606120: H-35 CL TRAUMA Cemented Femoral Stem
Official title: A Post-market Study Evaluating Clinical and Radiographic Early Outcomes of Hip Arthroplasty With CL TRAUMA Cemented Femoral Stem
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Arthroplasty
Replacement
Hip
Keywords: Hip replacement
Cemented stem
Lead sponsor: Limacorporate S.p.a
Sponsor class: INDUSTRY
First posted: 2022-11-04
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The eligible study population is represented by the entire population that underwent a hip replacement with CL TRAUMA femoral stem from 2017 to 2023.

Brief summary: 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.


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.

Primary outcomes:
measure: The primary endpoint is based upon Harris Hip score evaluation.
timeFrame: Performed only at survival follow-up (up to 7 years).
Secondary outcomes:
measure: Radiographic implant evaluation and stability assessment at different routinely post-operative timepoints.
timeFrame: Performed at discharge, 1 month follow-up, 2 years follow-up and at survival follow-up (up to 7 years).
measure: Survivorship of the implant (Kaplan-Meier estimate) after surgery at survival follow-up.
timeFrame: Performed only at survival follow-up (up to 7 years).
measure: Safety assessment
timeFrame: From surgery to survival follow-up (up to 7 years).
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Azienda Ospedale Università di Padova
Study officials:
References: