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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03570606

Acronym

ROSA

Enrollment

220

Registered

2018-06-27

Start date

2019-06-13

Completion date

2026-06-30

Last updated

2025-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Deformity

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.

Interventions

DEVICEbone graft substitute

orthopaedic or spine bony defects

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026