SUcceSS is the world’s first randomised, placebo-controlled study of decompression surgery for central lumbar canal stenosis. SUcceSS is being conducted in Sydney and Melbourne and is sponsored by the University of Sydney.
Lead Investigator: Professor Manuela Ferreira
SUcceSS Surgeons: Dr Ralph Mobbs, Dr Ralph Stanford, Dr Gavin Davis, Dr James van Gelder, Dr Raoul Pope, Dr Prashanth Rao, Dr Rajesh Reddy, Dr Peter Wilson, Dr Jacob Fairhall, Dr Gerald Quan
Approved Hospitals: Prince of Wales Hospital, Prince of Wales Private Hospital, Concord Repatriation General Hospital, Sydney South West Private Hospital, Austin Hospital, Cabrini Hospital, Mater Hospital
Clinical trial coordinator: Ms Joanna Prior.
What is the SUcceSS 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. While some patients who have this decompression surgery have relief from their symptoms, others do not, and we do not understand why.
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). The results will 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 is involved?
If eligible to participate in the study, randomisation will be performed, resulting in a 50% chance of receiving spinal decompression involving bone and ligament removal (decompression surgery) and a 50% chance of receiving spinal surgery without bone removal (placebo surgery).
After the surgery, the participant will be contacted to monitor their symptoms every 3 months for a period of 2 years. This contact will be conducted via telephone appointments.
Who is eligible?
- Those who are ≥40 years of age
- Those who have neurogenic claudication (e.g., pain, numbness, and/or fatigue in or below the buttocks that is worse with walking and better when you sitting or leaning forward).
- Those whose symptoms have been present for at least 3 months.
- Those whose symptoms have not improved with non-surgical management.
- Those who are eligible and medically fit to receive decompression surgery (single or dual level).
For any further information about SUcceSS, please call the research team (Professor Manuela Ferreira and Ms Joanna Prior) on (02) 8627 7228 or email firstname.lastname@example.org
For a more in depth look at SUcceSS, click here to view the ANZ Clinical Trials Registry.
SUcceSS has been approved by the South Eastern Sydney Local Health District Human Research Ethics Committee – HREC/17/POWH/601