SUcceSS is the world’s first randomised placebo-controlled study of decompression surgery for central lumbar canal stenosis conducted at the University of Sydney. The study is being conducted in Sydney and Melbourne.
Lead Investigator: Professor Manuela Ferreira
Study team: Mr David Anderson, Ms Emma Ho, Ms Joanna Prior, Mr Trent Li, Ms Simone Fitzgerald, Ms Nancy Cinnadaio
Study surgeons: Dr Ralph Mobbs, Dr Ralph Stanford, Dr Gavin Davis, Dr James van Gelder, Dr Raoul Pope, Dr Rajesh Reddy, Dr Peter Wilson, Dr Jacob Fairhall
What is this study about?
Lumbar stenosis occurs when the space around the spinal canal in the lower back becomes narrow, pressing on the spinal nerves. Surgery to treat lumbar stenosis involves a general anaesthetic and a small incision into the skin and muscles of the spine, to remove small portions of bone and ligament that are pressing on the nerves. This type of surgery is called ‘decompression’. Currently there is no definite evidence that removing bone and ligament is required to improve pain and walking after surgery. Only some of the patients who have this decompression surgery have relief from their symptoms, but others do not, for reasons that we do not understand.
To see how important the removal of bone and ligament is, we are performing a study that compares two types of spinal surgery; one that includes bone and ligament removal and another that does not (placebo). These results will then allow us to determine if the removal of bone and ligament during surgery (decompression surgery) is effective for the treatment of lumbar stenosis or not.
What does this study involve?
If you are eligible to join the study, you will have a 50% chance of being allocated to spinal decompression group or placebo group:
- Spinal decompression: Decompression surgery with bone and ligament removal
- Placebo: Same procedure, but without removal of bone and ligament in the spine.
After the surgery, we will then contact you to monitor your symptoms every 3 months over 2 years. Most of this contact will be conducted via telephone appointments.
Am I eligible?
You can participate if you:
- Are older than 40 years of age
- Have neurogenic claudication (e.g. pain, numbness, and/or fatigue in or below the buttocks that is worse with walking and better when you sit or lean forward.
- Your symptoms have been present for at least 3 months
- Eligible to receive decompression surgery (single or dual level)
SUcceSS has been approved by the South Eastern Sydney Local Health District Human Research Ethics Committee – HREC/17/POWH/601
Approved sites: Prince of Wales Hospital, Prince of Wales Private Hospital, Concord General Repatriation Hospital, Sydney South West Private Hospital, Austin Hospital, Cabrini Hospital
Please contact us for further information.
Phone: (02) 8627 7228