Cemented Acetabular Cups Clinical Study

Total Hip Arthroplasty Clinical Trial

Official title:

A Prospective Clinical Study Evaluating Clinical, Radiographic And Patient-Reported Outcomes Of THA With Cemented Acetabular Cups

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04831918
• Other study ID #: H-31
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: January 31, 2024

Study information

• Verified date: February 2024
• Source: Limacorporate S.p.a
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Total Hip Arthroplasty

Intervention

Device:
• Mueller cemented cups
Patients undergo total hip arthroplasty with the implant of Mueller cemented cups

Locations

Country	Name	City	State
Italy	Ospedale San Camillo di Trento	Trento	TN

Sponsors (1)

Lead Sponsor	Collaborator
Limacorporate S.p.a

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical progression of Harris Hip Score (HHS) from baseline to 2 years after surgery	HHS ranges from 0 to 100, being 0 the worst and 100 the best conditions. HHS is reported as 90-100 for excellent results, 80-90 for good, 70-79 for fair, 60-69 for poor, and below 60 for a failed result. The outcome is considered satisfactory for values over 80	2 years Follow up
Secondary	Radiographic evaluation and stability assessment of the implant up to 2 years FU	Radiographic stability, radiographically detectable complications	6 weeks, 1 year and 2 years FU
Secondary	Clinical progression of HOOS up to 2 years FU, compared to the baseline	Hip disability and osteoarthritis outcome score (HOOS) is a patient-reported outcome measurement, that ranges from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms	6 weeks, 1 year and 2 years FU
Secondary	Change in TUG from preoperative up to 2 years FU	Timed Up and Go	6 weeks, 1 year and 2 years FU
Secondary	Clinical progression of HHS up to 1 year FU, compared to the baseline	Harris Hip Score	6 weeks, 1 year
Secondary	Implant survivorship (Kaplan-Meier estimate) at 2 years after surgery		2 years FU
Secondary	Incidence of device-related AE/SAE up to 2 years of follow-up	Adverse events and device deficiencies	6 weeks, 1 year and 2 years FU