Prospective Observational Case Series Analysing Outcomes of Primary Hip Arthroplasty With a Short Cemented Stem (Friendly Short)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- change in percentage of the results of the absolute and weighted (age, gender) Harris Hip Score score from baseline to 1 year
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
change in percentage of the results of the absolute and weighted (age, gender) Harris Hip Score score from baseline to 1 year
Time Frame: up to 5 years FU
Change in Range Of Motion from baseline to 1 year.
Time Frame: up to 5 years FU
Change in percentage of the results of the Oxford Hip Score baseline to 1 year
Time Frame: up to 5 years FU
Secondary Outcomes
- Any possible adverse event or complication(up to 5 years FU)
- Rate of failure(up to 5 years FU)
- Radiographic stability(up to 5 years FU)