Cemented Acetabular Cups Clinical Study

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

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.

Study Overview

• Status: Completed
• Conditions: Total Hip Arthroplasty
• Intervention / Treatment: Device: Mueller cemented cups

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gaia Pacassoni; Phone Number: T +39 366 6248631; Email: gaia.pacassoni@limacorporate.com

Study Locations

• Italy
  • TN
    • Trento, TN, Italy, 38122
      • Ospedale San Camillo di Trento

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mueller cemented cups; Patients undergo total hip arthroplasty with the implant of the Mueller cemented cup as acetabular component.	Device: Mueller cemented cups; Patients undergo total hip arthroplasty with the implant of Mueller cemented cups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Implant survivorship (Kaplan-Meier estimate) at 2 years after surgery		2 years FU
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
Change in TUG from preoperative up to 2 years FU	Timed Up and Go	6 weeks, 1 year and 2 years FU
Clinical progression of HHS up to 1 year FU, compared to the baseline	Harris Hip Score	6 weeks, 1 year
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

Collaborators and Investigators

• Sponsor: Limacorporate S.p.a
• Investigators: Principal Investigator: Luca Marega, Ospedale San Camillo di Trento

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: April 1, 2021
• First Submitted That Met QC Criteria: April 1, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Cemented acetabular cup
• Other Study ID Numbers: H-31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No