ROSA
Research type
Research Study
Full title
A multi-centred, post-market clinical follow-up study of the Ceramisys ReproBone® synthetic bone graft substitutes for use in orthopaedic and spinal applications.
IRAS ID
250095
Contact name
Wayne Austin
Contact email
Sponsor organisation
Ceramisys Limited.
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
This is a post market clinical follow-up (PMCF) study of the Ceramisys ReproBone® product range. The objective of the study is to compile real world clinical data on safety and performance of the Ceramisys ReproBone® synthetic bone graft in a commercial clinical setting. Synthetic means the bone graft has been especially made to imitate the natural bone in a graft substitute.
The study will be conducted at a minimum of 6 UK/EU sites by surgeons who are experienced in or familiar with and skilled in the techniques of bone repair and replacement. A total of 175 subjects will receive the study treatment.
Patients included in this study will include males and females 18 – 80 years of age who require bone grafting in the spine, long bone or extremities resulting from traumatically or surgically created defects.
Each patient will be followed for a period of one year after enrolment according to the schedule and standard practice at the enrolling centers. There will be no additional visits, nor procedures, for subjects who participate in the study. Subjects are expected to be followed at implant, then at 3 months post-implant visit, and then at 6 months and through 1 year post implant. An intermediate visit may be a scheduled in a number of patients, per physician discretion. Follow-ups should not involve subjecting the patient to additional risks or burdens, therefore whilst x-rays/MRI evidence is required at the prescribed follow ups, the patient should not be subjected to evaluations above and beyond those normally considered by the evaluating surgeon unless ethical approval for this is obtained.
Primary endpoints will be successful radiographic bone repair.
Secondary Endpoints will include improvement in pain/function and measurement of absorption into the bodies circulation cells or tissue (material resorption), and where applicable loss of correction.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
18/YH/0472
Date of REC Opinion
17 Dec 2018
REC opinion
Favourable Opinion