Skip to main content
OpenTrials
Completed

NCT Number: NCT04987437

Prospective Observational Case Series of Primary Hip Arthroplasty With a Short Cemented Stem (Friendly Short)

Post-marketing observational case series to analyse the functional recover and radiographic outcomes in terms of implant stability and survivorship of primary hip arthroplasty with Friendly short cemented stem.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Clinico Sant'Anna

Brescia, 25127, Italy

About this study

The aim of this case series is to verify the functional recover and radiographic outcomes of primary hip arthroplasty with Friendly short cemented stem.

This is a post-marketing clinical investigation, the product on study is CE marked and used according to the intended use.

It is a national, mono-centre, prospective, observational case series on 100 patients in 1 site.

Primary endpoint is to investigate clinical progression of patients with THA with Friendly short stem from baseline to 1-year follow-up.

The secondary endpoint is to evaluate implant stability and survivorship of implants up to 5 years Follow-up.

The evaluation has an internal control because the assessment of post-treatment data is compared to baseline measurements (pre-operative clinical analysis and radiographic analysis at discharge).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients of both genders;
  • Patients of all ages, but > 18 years old;
  • Patients with primary and secondary coxarthrosis;
  • Patients with rheumatoid arthritis;
  • Patients with avascular necrosis;
  • Patients with neck (not diaphyseal) fractures;
  • Patients requiring a primary hip arthroplasty.

Exclusion criteria

  • Patients requiring a revision of a previous stem;
  • Patients with proven active or suspicious infections;
  • Patients with known hypersensitivity to used materials;
  • Patients with known active neoplastic or metastatic diseases;
  • Patients with significant neurological or musculoskeletal disorders that may affect functional recover;
  • Patients with proven haemophilic disease;
  • Patients with unwilling or unable to comply with rehabilitation or inability to return for follow-up visits;
  • Women with pregnancy or childbearing capacity or breast-feeding;
  • Subjects already enrolled in other clinical trials.

Treatment and study plan

Friendly short stem

Device

Total Hip Arthroplasty with Friendly Short stem

Primary outcomes

  1. change in percentage of the results of the absolute and weighted (age, gender) Harris Hip Score score from baseline to 1 year

    Time frame: up to 5 years FU

  2. Change in percentage of the results of the Oxford Hip Score baseline to 1 year

    Time frame: up to 5 years FU

  3. Change in Range Of Motion from baseline to 1 year.

    Time frame: up to 5 years FU

Secondary outcomes

  1. Radiographic stability

    Time frame: up to 5 years FU

    rate of signs of subsidence > 2mm or tilting

  2. Rate of failure

    Time frame: up to 5 years FU

    rate or revisions, loosening, failure of cement-stem interface, cement cracks, any definite change in the position of components

  3. Any possible adverse event or complication

    Time frame: up to 5 years FU

Sponsors and collaborators

Lead sponsor

Limacorporate S.p.a

Industry

Registry information

Official study title

Prospective Observational Case Series Analysing Outcomes of Primary Hip Arthroplasty With a Short Cemented Stem (Friendly Short)

Important dates

Study start
2011
Primary completion
2013
Study completion
2018
First posted
Aug 3, 2021
Registry last updated
Aug 3, 2021

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.

Published trials that share one or more normalized conditions with this study.