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

Completed

• Conditions: Total Hip Arthroplasty

• Registration Number: NCT04987437
• Lead Sponsor: Limacorporate S.p.a

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).

Study Timeline

• Study Start: 2011-05-02
• Primary Completion: 2013-12-06
• Study Completion: 2018-11-06
• Study First Submitted: 2021-07-27
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-02
• Last Update Submitted: 2021-08-02
• Study First Posted: 2021-08-03
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Range Of Motion 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

Secondary Outcome Measures

Name	Time	Method
Any possible adverse event or complication	up to 5 years FU
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
Radiographic stability	up to 5 years FU	rate of signs of subsidence \> 2mm or tilting

Trial Locations

Locations (1)

Istituto Clinico Sant'Anna; 🇮🇹 Brescia, Italy