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Completed

NCT Number: NCT04831918

Cemented Acetabular Cups Clinical Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale San Camillo di Trento

Trento, TN, 38122, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mueller cemented cups

Device

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

Primary outcomes

  1. 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

  1. Radiographic evaluation and stability assessment of the implant up to 2 years FU

    Time frame: 6 weeks, 1 year and 2 years FU

    Radiographic stability, radiographically detectable complications

  2. Clinical progression of HOOS up to 2 years FU, compared to the baseline

    Time frame: 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

  3. Change in TUG from preoperative up to 2 years FU

    Time frame: 6 weeks, 1 year and 2 years FU

    Timed Up and Go

  4. Clinical progression of HHS up to 1 year FU, compared to the baseline

    Time frame: 6 weeks, 1 year

    Harris Hip Score

  5. Implant survivorship (Kaplan-Meier estimate) at 2 years after surgery

    Time frame: 2 years FU

  6. Incidence of device-related AE/SAE up to 2 years of follow-up

    Time frame: 6 weeks, 1 year and 2 years FU

    Adverse events and device deficiencies

Sponsors and collaborators

Lead sponsor

Limacorporate S.p.a

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 5, 2021
Registry last updated
Mar 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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