Arthroplasty, Replacement, Hip
Conditions
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.
Interventions
DEVICEArthroplasty hip
Hip replacement
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxford Hip score | 10 years | Oxford Hip Score at 1,3,5, 7 and 10 year postop, Oxford Hip score 0-48 points, The higher the positive difference the better the result. |
Countries
Denmark, United Kingdom
Outcome results
None listed