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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-02

Study Completion Date

2018-11-06

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Total Hip Arthroplasty

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Friendly short stem

Total Hip Arthroplasty with Friendly Short stem

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No