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Clinical Study of Bone Graft Substitutes in Orthopaedic and Spinal Applications. (ROSA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03570606
Recruitment Status : Recruiting
First Posted : June 27, 2018
Last Update Posted : March 9, 2022
Sponsor:
Information provided by (Responsible Party):
Ceramisys Ltd

Study Description
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Brief Summary:
This is an observational, prospective, non-randomised, multi-centred post market clinical follow-up study to compile real world clinical data on safety and efficacy of the synthetic bone graft substitutes in a commercial clinical setting in long bone and extremity defects and in spinal fusion procedures.

Condition or disease Intervention/treatment
Bone Deformity Device: bone graft substitute

Study Design
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Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Multi-centred, Post-market Clinical Follow-up Study of Synthetic Bone Graft Substitutes for Use in Orthopaedic and Spinal Applications.
Actual Study Start Date : June 13, 2019
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Groups and Cohorts
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Group/Cohort Intervention/treatment
HA Paste in Spine

Evaluation of HA Paste in spinal fusion procedures

o Spinal cage filling

 Device: bone graft substitute
orthopaedic or spine bony defects
HA Paste in long bone & extremities

Evaluation of HA Paste in long bone and extremity group:

  • Filling bone defects after cyst removal
  • Filling distal radius fractures
  • Filling defects such as tibial plateau fractures
  • Filling defects created by osteotomy procedures
 Device: bone graft substitute
orthopaedic or spine bony defects
Granulated Paste in Spine

Evaluation of Granulated Paste in spinal fusion procedures

o Spinal cage filling

 Device: bone graft substitute
orthopaedic or spine bony defects
Granulated Paste in long bone & extremities

Evaluation of Granulated Paste in long bone and extremity group:

  • Filling bone defects after cyst removal
  • Filling distal radius fractures
  • Filling defects such as tibial plateau fractures
  • Filling defects created by osteotomy procedures
 Device: bone graft substitute
orthopaedic or spine bony defects
Granules in Spine

Evaluation of Granules in spinal fusion procedures

o Spinal cage filling

 Device: bone graft substitute
orthopaedic or spine bony defects
Granules in long bone & extremities

Evaluation of Granules in long bone and extremity group:

  • Filling bone defects after cyst removal
  • Filling distal radius fractures
  • Filling defects such as tibial plateau fractures
  • Filling defects created by osteotomy procedures
 Device: bone graft substitute
orthopaedic or spine bony defects
Block in long bone & extremities

Evaluation of Blocks in long bone and extremity group:

o High tibial osteotomies with fixation

 Device: bone graft substitute
orthopaedic or spine bony defects


Outcome Measures
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Primary Outcome Measures :
  1. Primary endpoints will be successful radiographic bone repair. [ Time Frame: 12 months ]
    Bone formation and material resorption, observable by x-ray/MRI


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
male or female 18-80 meeting the inclusion criteria, provided no exclusion criteria are met:
Criteria

Inclusion Criteria:

Long Bone and Extremity Indications: patients requiring bone grafting after post-traumatic or surgically created bone defects afflicting the long bones and extremities.

Spine Indication: patients with degenerative disc disease or trauma who require spinal fusion of 1 or more vertebral bodies and where conservative treatment has been unsuccessful.

Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center;

Exclusion Criteria:

Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.

Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion); The subject is unable or not willing to complete follow-up visits and examination for the duration of the study.

Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03570606


Contacts
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Contact: Rebecca Hutchinson +441142327070 b.hutchinson@ceramisys.com

Locations
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United Kingdom
Doncaster & Bassetlaw Teaching Hospitals NHS Foundation Trust Recruiting
Doncaster, South Yorkshire, United Kingdom, DN2 5LT
Contact: Sanjeev Madan         
The Royal Orthopaedic Hospital NHS Foundation Trust Recruiting
Birmingham, United Kingdom
Northumbria Healthcare NHS Foundation Trust Recruiting
North Shields, United Kingdom
Salford Royal NHS Foundation Trust Recruiting
Salford, United Kingdom
University Hospitals of North Midlands NHS Trust Recruiting
Stoke-on-Trent, United Kingdom
Taunton and Somerset NHS Foundation Trust Recruiting
Taunton, United Kingdom
Sponsors and Collaborators
Ceramisys Ltd
More Information
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Responsible Party: Ceramisys Ltd
ClinicalTrials.gov Identifier: NCT03570606    
Other Study ID Numbers: ROSA01
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Congenital Abnormalities