Multicentre Prospective Study to Evaluate Long-term Clinical Outcomes of the Sirius Cemented Femoral Stem

Zimmer Biomet2 sites in 2 countries250 target enrollmentMarch 2013

ConditionsArthroplasty, Replacement, Hip

Overview

Phase: N/A
Intervention: Not specified
Conditions: Arthroplasty, Replacement, Hip
Sponsor: Zimmer Biomet
Enrollment: 250
Locations: 2
Primary Endpoint: Harris Hip Score
Status: Active, Not Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this multicentre, prospective study is:

Document the Clinical and Radiographic performance of the stem at 3 months, 1 year, 3 years, 5 years, 7 and 10 years.
Report Safety and Survivorship up to 10 years F/up.

Detailed Description

This study intends to evaluate the safety and performance of the Sirus cemented hip stem in terms of function improvement postoperatively, stability and fixation of femoral stem and survivorship.

Registry

clinicaltrials.gov

Start Date

March 2013

End Date

March 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Zimmer Biomet

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Selection of subjects for this evaluation should be in accordance with the indications of Sirus stem:
•Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
•Rheumatoid arthritis
•Correction of functional deformity
•Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
•Revision procedures where other treatments or devices have failed. The Sirius Femoral Hip Stem is intended for cemented use only and may be used in partial and total hip arthroplasties

Exclusion Criteria

•Absolute contraindications include:
•infection, sepsis, osteomyelitis
•Additional contraindications include:
•Uncooperative patient or patient with neurologic disorders who are incapable of following directions,
•Osteoporosis,
•Metabolic disorders which may impair bone formation
•Osteomalacia
•Distant foci of infections which may spread to the implant site
•Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
•Vascular insufficiency, muscular atrophy or neuromuscular disease.

Outcomes

Primary Outcomes

Harris Hip Score

Time Frame: 1 year

Change in Harris Hip Score from Baseline to 1 Year post-surgery, Harris Hip Score, 0-100 points. The higher the positive difference between baseline and follow up the better the result