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

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ClinicalTrials.gov Identifier: NCT03570606
Recruitment Status : Not yet recruiting
First Posted : June 27, 2018
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Ceramisys Ltd

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 Type : Observational
Estimated Enrollment : 175 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.
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Group/Cohort Intervention/treatment
HA Paste in Spinal

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




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



Information from the National Library of Medicine

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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.


Responsible Party: Ceramisys Ltd
ClinicalTrials.gov Identifier: NCT03570606     History of Changes
Other Study ID Numbers: ROSA01
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No