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)

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.

Study Overview

• Status: Completed
• Conditions: Total Hip Arthroplasty
• Intervention / Treatment: Device: Friendly short 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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Italy
  • Brescia, Italy, 25127
    • Istituto Clinico Sant'Anna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients requiring a primary hip arthroplasty, due to primary and secondary coxarthrosis, avascular necrosis, rheumatoid arthritis, neck (but not diaphyseal) fractures

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Radiographic stability	rate of signs of subsidence > 2mm or tilting	up to 5 years FU
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
Any possible adverse event or complication		up to 5 years FU

Collaborators and Investigators

• Sponsor: Limacorporate S.p.a

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2011
• Primary Completion (Actual): December 6, 2013
• Study Completion (Actual): November 6, 2018

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): August 3, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: H-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No