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.
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).
Study Type
OBSERVATIONAL
Enrollment
100
Total Hip Arthroplasty with Friendly Short stem
Istituto Clinico Sant'Anna
Brescia, Italy
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
Change in percentage of the results of the Oxford Hip Score baseline to 1 year
Time frame: up to 5 years FU
Change in Range Of Motion from baseline to 1 year.
Time frame: up to 5 years FU
Radiographic stability
rate of signs of subsidence \> 2mm or tilting
Time frame: up to 5 years FU
Rate of failure
rate or revisions, loosening, failure of cement-stem interface, cement cracks, any definite change in the position of components
Time frame: up to 5 years FU
Any possible adverse event or complication
Time frame: up to 5 years FU
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