Clinical trial NCT04831918: Cemented Acetabular Cups Clinical Study
Official title: A Prospective Clinical Study Evaluating Clinical, Radiographic And Patient-Reported Outcomes Of THA With Cemented Acetabular Cups
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Hip Arthroplasty
Keywords: Cemented acetabular cup
Lead sponsor: Limacorporate S.p.a
Sponsor class: INDUSTRY
First posted: 2021-04-05
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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, in order to assess the performance of the device. Furthermore, it aims to collect short-term survivorship of the implant and the incidence of early complications.


Eligibility criteria: Inclusion Criteria:

1. The patient has participated in the Informed Consent process and has signed the Informed Consent form previously approved by the Ethics Committee;
2. 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.
3. The patient is willing and able to complete scheduled follow-up evaluations as described in the Patient Information Sheet;

Exclusion Criteria:

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:

1. Acute or chronic infections, local or systemic infections;
2. Serious muscular, neurological or vascular diseases affecting the concerned limb;
3. Any concomitant disease and dependence that might affect the implanted prosthesis;
4. Allergy to material;
5. Metal-on-metal systems: patients with renal impairment.
6. Patient's age\<18
7. Female patients who are pregnant, nursing, or planning a pregnancy.

Primary outcomes:
measure: Clinical progression of Harris Hip Score (HHS) from baseline to 2 years after surgery
timeFrame: 2 years Follow up
Secondary outcomes:
measure: Radiographic evaluation and stability assessment of the implant up to 2 years FU
timeFrame: 6 weeks, 1 year and 2 years FU
measure: Clinical progression of HOOS up to 2 years FU, compared to the baseline
timeFrame: 6 weeks, 1 year and 2 years FU
measure: Change in TUG from preoperative up to 2 years FU
timeFrame: 6 weeks, 1 year and 2 years FU
measure: Clinical progression of HHS up to 1 year FU, compared to the baseline
timeFrame: 6 weeks, 1 year
measure: Implant survivorship (Kaplan-Meier estimate) at 2 years after surgery
timeFrame: 2 years FU
measure: Incidence of device-related AE/SAE up to 2 years of follow-up
timeFrame: 6 weeks, 1 year and 2 years FU
Other outcomes:
Locations:
city: Trento
country: Italy
facility: Ospedale San Camillo di Trento
state: TN
Study officials:
affiliation: Ospedale San Camillo di Trento
name: Luca Marega
role: PRINCIPAL_INVESTIGATOR
References: