Clinical trial NCT04987437: Prospective Observational Case Series of Primary Hip Arthroplasty With a Short Cemented Stem (Friendly Short)
Official title: Prospective Observational Case Series Analysing Outcomes of Primary Hip Arthroplasty With a Short Cemented Stem (Friendly Short)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Hip Arthroplasty
Lead sponsor: Limacorporate S.p.a
Sponsor class: INDUSTRY
First posted: 2021-08-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients requiring a primary hip arthroplasty, due to primary and secondary coxarthrosis, avascular necrosis, rheumatoid arthritis, neck (but not diaphyseal) fractures

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: change in percentage of the results of the absolute and weighted (age, gender) Harris Hip Score score from baseline to 1 year
timeFrame: up to 5 years FU
measure: Change in percentage of the results of the Oxford Hip Score baseline to 1 year
timeFrame: up to 5 years FU
measure: Change in Range Of Motion from baseline to 1 year.
timeFrame: up to 5 years FU
Secondary outcomes:
measure: Radiographic stability
timeFrame: up to 5 years FU
measure: Rate of failure
timeFrame: up to 5 years FU
measure: Any possible adverse event or complication
timeFrame: up to 5 years FU
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Istituto Clinico Sant'Anna
Study officials:
References: