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Active Not RecruitingNCT02371382

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

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 Surv...

Lead sponsor: Zimmer Biomet•2 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Zimmer Biomet

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.

Age

18 - No limit years

Sex

ALL

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 1, 2024Terms

Trial snapshot

StatusACTIVE_NOT_RECRUITING

Phase—

Enrollment250

Start dateMar 2013

Last updatedJul 1, 2024

Condition

Arthroplasty, Replacement, Hip

Locations shown

Sygehus Vejle

Vejle

University Hospital of Wales, Llandough Hospital

Penarth, Wales

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 1, 2024Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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