Cemented Acetabular Cups Clinical Study

Not Applicable

Completed

• Conditions: Total Hip Arthroplasty
• Interventions: Device: Mueller cemented cups

• Registration Number: NCT04831918
• Lead Sponsor: Limacorporate S.p.a

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-04-01
• Study First Submitted QC: 2021-04-01
• Study First Posted: 2021-04-05
• Primary Completion: 2024-01-31
• Study Completion: 2024-01-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mueller cemented cups	Mueller cemented cups	Patients undergo total hip arthroplasty with the implant of the Mueller cemented cup as acetabular component.

Primary Outcome Measures

Name	Time	Method
Clinical progression of Harris Hip Score (HHS) from baseline to 2 years after surgery	2 years Follow up	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

Secondary Outcome Measures

Name	Time	Method
Implant survivorship (Kaplan-Meier estimate) at 2 years after surgery	2 years FU
Clinical progression of HOOS up to 2 years FU, compared to the baseline	6 weeks, 1 year and 2 years FU	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
Change in TUG from preoperative up to 2 years FU	6 weeks, 1 year and 2 years FU	Timed Up and Go
Clinical progression of HHS up to 1 year FU, compared to the baseline	6 weeks, 1 year	Harris Hip Score
Radiographic evaluation and stability assessment of the implant up to 2 years FU	6 weeks, 1 year and 2 years FU	Radiographic stability, radiographically detectable complications
Incidence of device-related AE/SAE up to 2 years of follow-up	6 weeks, 1 year and 2 years FU	Adverse events and device deficiencies

Trial Locations

Locations (1)

Ospedale San Camillo di Trento; 🇮🇹 Trento, TN, Italy