Cemented Acetabular Cups Clinical Study

NCT04831918 | Completed

• 1 other identifier: H-31
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Hip Arthroplasty

Keywords

Cemented acetabular cup

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• 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

Study Arms (1)

Mueller cemented cups

EXPERIMENTAL

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

Device: Mueller cemented cups

Interventions

Mueller cemented cups DEVICE

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

Mueller cemented cups

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Limacorporate S.p.a: lead

Study Sites (1)

Ospedale San Camillo di Trento

Trento, TN, 38122, Italy

Location

Study Officials

• Luca Marega

  Ospedale San Camillo di Trento

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 5, 2021
• Study Start: March 1, 2021
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: March 4, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)