Status:
COMPLETED
Cemented Acetabular Cups Clinical Study
Lead Sponsor:
Limacorporate S.p.a
Conditions:
Total Hip Arthroplasty
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This clinical study has the aim to evaluate clinical, radiographic, patient-reported outcomes of total hip arthroplasty with the implant of Mueller cemented acetabular cups up to 2 years after surgery...
Eligibility Criteria
Inclusion
- The patient has participated in the Informed Consent process and has signed the Informed Consent form previously approved by the Ethics Committee;
- The patient diagnosis is one or more of the following:
- Patient with advanced articular destruction generated by primary degenerative or post-traumatic arthrosis or rheumatoid arthritis;
- Patient with avascular necrosis of the femoral head or fracture of the femoral neck;
- Patient with congenital or acquired deformity;
- Patient with failures of previous operations, like osteosynthesis, articular reconstruction, arthrodesis, hemi-arthroplasty or total arthroplasty.
- The patient is willing and able to complete scheduled follow-up evaluations as described in the Patient Information Sheet;
Exclusion
- The patient should be excluded from the study if he/she meets any of the following criteria, which reflect the cemented acetabular cup contraindication for use:
- Acute or chronic infections, local or systemic infections;
- Serious muscular, neurological or vascular diseases affecting the concerned limb;
- Any concomitant disease and dependence that might affect the implanted prosthesis;
- Allergy to material;
- Metal-on-metal systems: patients with renal impairment.
- Patient's age\<18
- Female patients who are pregnant, nursing, or planning a pregnancy.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2024
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04831918
Start Date
March 1 2021
End Date
January 31 2024
Last Update
March 4 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ospedale San Camillo di Trento
Trento, TN, Italy, 38122