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

Zimmer Biomet

Status: Active, not recruiting

Conditions: Arthroplasty, Replacement, Hip

Treatments: Device: Arthroplasty hip

Study type: Observational

Funder types: Industry

Identifiers

NCT02371382

ORTHO.CR.H41

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Selection of subjects for this evaluation should be in accordance with the indications of Sirus stem:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. 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.