Cemented Acetabular Cups Clinical Study

Sponsor

Limacorporate S.p.a (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04831918

Collaborator

(none)

Enrollment

Location

Arm

45.7

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Total Hip Arthroplasty	Device: Mueller cemented cups	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Dec 22, 2024

Anticipated Study Completion Date :

Dec 22, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Radiographic evaluation and stability assessment of the implant up to 2 years FU [6 weeks, 1 year and 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]
Clinical progression of HHS up to 1 year FU, compared to the baseline [6 weeks, 1 year]
Implant survivorship (Kaplan-Meier estimate) at 2 years after surgery [2 years FU]
Incidence of device-related AE/SAE up to 2 years of follow-up [6 weeks, 1 year and 2 years FU]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale San Camillo di Trento	Trento	TN	Italy	38122

Sponsors and Collaborators

Limacorporate S.p.a

Investigators

Principal Investigator: Luca Marega, Ospedale San Camillo di Trento

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Limacorporate S.p.a

ClinicalTrials.gov Identifier:

NCT04831918

Other Study ID Numbers:

H-31

First Posted:

Apr 5, 2021

Last Update Posted:

Jul 23, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Limacorporate S.p.a

Cemented acetabular cup

Study Results

No Results Posted as of Jul 23, 2021