POLYFIX DCM
Research type
Research Study
Full title
POsterior Laminectomy and FIXation for Degenerative Cervical Myelopathy [POLYFIX-DCM]
IRAS ID
297923
Contact name
Benjamin M Davies
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust & The University of Cambridge
ISRCTN Number
ISRCTN12638817
Duration of Study in the UK
6 years, 3 months, 30 days
Research summary
Degenerative Cervical Myelopathy [DCM] is a common condition caused when arthritic changes in the neck compress the spinal cord. It affects up to 2% of adults and causes numb and clumsy hands, imbalance, and bladder problems. Often it continues to worsen with time and left untreated lead to severe disability and paralysis.
The only current treatment is surgery to create space for the spinal cord. Surgery is able to stop further deterioration and lead to some improvements, and a number of different procedures are used.
For people who need DCM surgery from the back of their neck, the pressure on the spinal cord is relieved by removing part of the bone that surrounds the spinal cord called the laminae. This procedure on its own is called a laminectomy. In some cases, metal implants are placed in addition to the laminectomy in order to stiffen the spine. This is called laminectomy and fusion.
Both procedures have potential advantages and disadvantages.
Laminectomy alone is a more straightforward and a shorter surgery, that does not affect the range of movement in the neck. However, without fusion a change in the alignment of the spine, called deformity may develop. Some surgeons believe deformity may affect long-term recovery and may cause greater neck pain for some people.
Laminectomy and fusion aims to prevent this deformity, but in doing so will greatly reduce the range of movement in the neck. Furthermore, the insertion of metal work slightly increases the risks of the surgery, and greatly increases the cost.
We propose to address the following question, using a randomised controlled trial:
‘Does laminectomy alone or laminectomy with fusion lead to better recovery in patients undergoing surgery for DCM from the back’?
Patients scheduled to undergo posterior surgery for DCM will be allocated using a computer to one or other treatment. This will involve 394 patients across 30+ sites, mainly based in the UK.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
21/YH/0253
Date of REC Opinion
5 Nov 2021
REC opinion
Favourable Opinion