Prospective Observational Case Series of Primary Hip Arthroplasty With a Short Cemented Stem (Friendly Short)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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).
Study Design
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients of both genders;
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Patients of all ages, but > 18 years old;
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Patients with primary and secondary coxarthrosis;
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Patients with rheumatoid arthritis;
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Patients with avascular necrosis;
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Patients with neck (not diaphyseal) fractures;
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Patients requiring a primary hip arthroplasty.
Exclusion Criteria:
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Patients requiring a revision of a previous stem;
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Patients with proven active or suspicious infections;
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Patients with known hypersensitivity to used materials;
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Patients with known active neoplastic or metastatic diseases;
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Patients with significant neurological or musculoskeletal disorders that may affect functional recover;
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Patients with proven haemophilic disease;
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Patients with unwilling or unable to comply with rehabilitation or inability to return for follow-up visits;
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Women with pregnancy or childbearing capacity or breast-feeding;
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Subjects already enrolled in other clinical trials.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Istituto Clinico Sant'Anna | Brescia | Italy | 25127 |
Sponsors and Collaborators
- Limacorporate S.p.a
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H-02