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

Limacorporate S.p.a1 site in 1 country45 target enrollmentMarch 1, 2021

ConditionsTotal Hip Arthroplasty

Overview

Phase: N/A
Intervention: Not specified
Conditions: Total Hip Arthroplasty
Sponsor: Limacorporate S.p.a
Enrollment: 45
Locations: 1
Primary Endpoint: Clinical progression of Harris Hip Score (HHS) from baseline to 2 years after surgery
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 1, 2021

End Date

January 31, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Limacorporate S.p.a

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Clinical progression of Harris Hip Score (HHS) from baseline to 2 years after surgery

Time Frame: 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 Outcomes

Clinical progression of HOOS up to 2 years FU, compared to the baseline(6 weeks, 1 year and 2 years FU)
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)
Radiographic evaluation and stability assessment of the implant up to 2 years FU(6 weeks, 1 year and 2 years FU)
Incidence of device-related AE/SAE up to 2 years of follow-up(6 weeks, 1 year and 2 years FU)