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

June 27, 2023 updated by: Zimmer Biomet

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.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Vejle, Denmark, 7100
        • Sygehus Vejle
    • Wales
      • Penarth, Wales, United Kingdom, CF64 2XX
        • University Hospital of Wales, Llandough Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

minimum age: 18 maximum age: gender: both

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Harris Hip Score
Time Frame: 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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxford Hip score
Time Frame: 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.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Alun John, University Hospital of Wales
  • Principal Investigator: Per Kjærsgaard-Andersen, MD, Lillebaelt Hospital Vejle, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

February 19, 2015

First Submitted That Met QC Criteria

February 19, 2015

First Posted (Estimated)

February 25, 2015

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 27, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • ORTHO.CR.H41

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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