Minimally invasive delivery of osteospheres PPI questionnaire.
Research type
Research Study
Full title
Development of Prototype Device for Minimally Invasive Delivery of Osteospheres for Treatment of Osteoporosis
IRAS ID
224310
Contact name
Thomas Clutton-Brock
Contact email
Sponsor organisation
University Hospitals Birmingham NHS Trust
Duration of Study in the UK
0 years, 3 months, 0 days
Research summary
Currently, over 60,000 hip, 50,000 wrist and 120,000 vertebral osteoporosis related fractures occur each year in the UK, with an attendant health and social care combined cost of £1.73 billion per year in the UK alone. Effective treatment to reduce the risk of osteoporosis fracture would reduce these pressures.
An NIHR i4i funded research consortium is developing novel tiny biodegradable porous beads (referred to as microspheres) for treatment of osteoporosis. The microspheres will deliver the patients' own stem cells to both repair and regenerate new bone tissue, reducing the fracture risk. The project involves several parallel workstreams prior to conducting pre-clinical and clinical trials including a Patient Public Involvement (PPI) study to enable the research team to understand patients’ perceptions on the use of their own stem cells for this intervention and the means by which these cells are extracted and then reinjected.
The PPI study consists of a questionnaire developed with the input of a PPI reference group from the Birmingham 1000 Elders group and the National Osteoporosis Society. The questionnaire is available through the National Osteoporosis Society with ethical approval from the University of Birmingham. The applicants seek further approval to allow distribution of the questionnaire through osteoporosis and fracture clinics in at Nottingham, Birmingham and Leeds in order to capture the views of subjects living with osteoporosis. The PPI study also seeks to determine whether the online fracture scores FRAX and QFracture would be useful in selecting patients in subsequent clinical trials. This will be determined by asking patients with recent DEXA scan to include the scan results and complete a section of the questionnaire to allow the research team to calculate the fracture scores.
REC name
Wales REC 7
REC reference
18/WA/0020
Date of REC Opinion
18 Jan 2018
REC opinion
Favourable Opinion