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

A Multi-centred, Post-market Clinical Follow-up Study of Synthetic Bone Graft Substitutes for Use in Orthopaedic and Spinal Applications.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Bone Deformity
• Intervention / Treatment: Device: bone graft substitute

• Study Type: Observational
• Enrollment (Estimated): 220

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom
    • Sandwell and West Birmingham NHS Trust of City Hospital
  • Birmingham, United Kingdom
    • The Royal Orthopaedic Hospital NHS Foundation Trust
  • North Shields, United Kingdom
    • Northumbria Healthcare NHS Foundation Trust
  • Salford, United Kingdom
    • Salford Royal NHS Foundation Trust
  • Stoke-on-Trent, United Kingdom
    • University Hospitals of North Midlands NHS Trust
  • Taunton, United Kingdom
    • Taunton and Somerset NHS Foundation Trust
  • South Yorkshire
    • Doncaster, South Yorkshire, United Kingdom, DN2 5LT
      • Doncaster & Bassetlaw Teaching Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

male or female 18-80 meeting the inclusion criteria, provided no exclusion criteria are met:

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

7

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary endpoints will be successful radiographic bone repair.	Bone formation and material resorption, observable by x-ray/MRI	12 months

Collaborators and Investigators

• Sponsor: Ceramisys Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2019
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: June 18, 2018
• First Submitted That Met QC Criteria: June 18, 2018
• First Posted (Actual): June 27, 2018

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: ROSA01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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