NCT04987437

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Limacorporate S.p.a · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Total Hip Arthroplasty

Interventions

Type	Name	Description
DEVICE	Friendly short stem	Total Hip Arthroplasty with Friendly Short stem

Timeline

• Start date: 2011-05-02
• Primary completion: 2013-12-06
• Completion: 2018-11-06
• First posted: 2021-08-03
• Last updated: 2021-08-03

Locations

1 site across 1 country: Italy