Total Hip Arthroplasty
Conditions
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).
Interventions
DEVICEFriendly short stem
Total Hip Arthroplasty with Friendly Short stem
Sponsors
Limacorporate S.p.a
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in percentage of the results of the absolute and weighted (age, gender) Harris Hip Score score from baseline to 1 year | up to 5 years FU |
| Change in percentage of the results of the Oxford Hip Score baseline to 1 year | up to 5 years FU |
| Change in Range Of Motion from baseline to 1 year. | up to 5 years FU |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic stability | up to 5 years FU | rate of signs of subsidence \> 2mm or tilting |
| Rate of failure | up to 5 years FU | rate or revisions, loosening, failure of cement-stem interface, cement cracks, any definite change in the position of components |
| Any possible adverse event or complication | up to 5 years FU | — |
Countries
Italy
Outcome results
None listed