MELODY
Research type
Research Study
Full title
Multiple Myeloma Spinal Disease Study; A prospective, single blinded, randomised, controlled study to compare balloon kyphoplasty with conservative management alone in the treatment of Vertebral Compression Fractures (VCFs) in patients with Multiple Myeloma.
IRAS ID
169682
Contact name
Charalampia Kyriakou
Contact email
Sponsor organisation
Royal National Orthopaedic Hospital NHS Trust
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Currently in the NHS, Haematologists treat multiple myeloma patients with a fracture in their back with a combination of different types of medicines routinely used as part of standard of care; this is known as conservative treatment. We would like to propose an alternative surgical treatment option which is not routinely performed within the NHS. The treatment we wish to propose is a surgical procedure, a balloon kyphoplasty. A balloon kyphoplasty is a medical device which involves inserting a balloon into the broken bone and slowly inflating the balloon to increase the height of the bone. The balloon is then deflated and the space is filled with bone cement. The purpose of the study is to compare two different types of treatment groups at the Royal National Orthopaedic Hospital NHS Trust for patients that have been diagnosed with Multiple Myeloma. The study will take place over four years (2 years for recruiting patients with a 2 year follow up period). Treatment group 1 involves patients receiving a sham procedure. The sham procedure involves participant going to the operating room and receiving sedation (in a sleep-like state) and the balloon kyphoplasty procedure is not performed. The purpose of the sham procedure is to simulate a pretend balloon kyphoplasty procedure so the patient is unaware of which treatment group they have been placed in. Treatment group 2 involves patients receiving the balloon kyphoplasty procedure under general anaesthesia (placed in an unconscious state for the duration of the procedure) and a sample of the spine will be taken. The purpose of our study is to provide evidence whether balloon kyphoplasty should be used when a patient with multiple myeloma develops a fracture of their back. This will enable patients in the future to get the most appropriate and best care from the NHS.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
15/LO/0431
Date of REC Opinion
30 Apr 2015
REC opinion
Further Information Favourable Opinion