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

Arthroplasty, Replacement, Hip Clinical Trial

— Sirius  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02371382
• Other study ID #: ORTHO.CR.H41
• Status: Active, not recruiting
• Start date: March 2013
• Est. completion date: March 2025

Study information

• Verified date: June 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip

Intervention

Device:
• Arthroplasty hip
Hip replacement

Locations

Country	Name	City	State
Denmark	Sygehus Vejle	Vejle
United Kingdom	University Hospital of Wales, Llandough Hospital	Penarth	Wales

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

Denmark,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Harris Hip Score	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	1 year
Secondary	Oxford Hip score	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.	10 years