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

Total Hip Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04987437
• Other study ID #: H-02
• Status: Completed
• Start date: May 2, 2011
• Est. completion date: November 6, 2018

Study information

• Verified date: August 2021
• Source: Limacorporate S.p.a
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 6, 2018
• Est. primary completion date: December 6, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Total Hip Arthroplasty

Intervention

Device:
• Friendly short stem
Total Hip Arthroplasty with Friendly Short stem

Locations

Country	Name	City	State
Italy	Istituto Clinico Sant'Anna	Brescia

Sponsors (1)

Lead Sponsor	Collaborator
Limacorporate S.p.a

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in percentage of the results of the Oxford Hip Score baseline to 1 year		up to 5 years FU
Primary	Change in Range Of Motion from baseline to 1 year.		up to 5 years FU
Secondary	Radiographic stability	rate of signs of subsidence > 2mm or tilting	up to 5 years FU
Secondary	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
Secondary	Any possible adverse event or complication		up to 5 years FU