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

ACTIVE_NOT_RECRUITING

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

NCT02371382•Zimmer Biomet

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.

Locations (2)

Sygehus Vejle

Vejle, Denmark

University Hospital of Wales, Llandough Hospital

Penarth, Wales, United Kingdom

Key Dates

Start Date

March 1, 2013

Primary Completion Date

March 1, 2025

Completion Date

March 1, 2025

Last Updated

July 1, 2024

Enrollment

250

ESTIMATED participants

Conditions

Arthroplasty, Replacement, Hip

Interventions

Arthroplasty hip

DEVICE

Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.

NCT05169229

Arthroplasty, Replacement, HipOsteoarthritis, Hip+2 more

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RECRUITINGNA

Low Concentration Local Anesthesia Fascia Iliaca Block for Total Hip Arthroplasty

NCT06102811

Arthroplasty, Replacement, Hip

View study

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: March 29, 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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Multicentre Prospective Study to Evaluate Long-term Clinical Outcomes of the Sirius Cemented Femoral Stem

Inclusion Criteria

Exclusion Criteria

Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.

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