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

Study Overview
=================
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).

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

Conditions
-----------------
Total Hip Arthroplasty

Intervention / Treatment
-----------------
* Device: Friendly short stem


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Friendly short stem|Total Hip Arthroplasty with Friendly Short stem|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic stability | rate of signs of subsidence > 2mm or tilting | 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 | up to 5 years FU | 
| Any possible adverse event or complication |  | up to 5 years FU |