Lumbar spinal stenosis (LSS), is a common disorder of narrowing of the spinal canal in the
lower part of the back. This causes discomfort in the legs when standing or walking because
of pressure on the spinal nerves.There are several treatment options for LSS including
physiotherapy, lumbar surgical decompression procedures such as laminectomy, Foraminotomy,
Discectomy and more recently devices for interspinous distraction such as the XSTOP® and from
May 2011 Minuteman™.
Surgical decompression for LSS involves the removal of excess bone, ligament, and soft-tissue
allowing more room for the nerves. The operation is usually preformed under general
anaesthetic and with an average stay in hospital for 2-3 nights. Whereas the Minuteman™
implant is preformed as a day case under local or general anaesthetic and involves implanting
the device into the space between two back bones to relieve pressure on the nerves and,
therefore, pain in the legs.
This is a multi centred (four sites) randomised controlled trial with a total sample of 50
participants after obtaining their informed consent. Participants will attend the pain clinic
at the Hospitals for a baseline visit where they will be randomised with a ratio of 1:1 to
receive either the Minuteman™ Interspinous interlaminar fusion Implant or standard surgical
decompression for the treatment of lumbar spinal stenosis (LSS). Following randomisation
arrangements will be made for the participant to receive the randomised treatment. If
allocated to Minuteman™ Implant, the treatment will be conducted by the Pain Specialist
identified at the site. If allocated to surgical decompression, the treatment will be
conducted by the neuro/spinal-surgeon identified at the site. Participates will be followed
up regularly for 60 months post implant to assess clinical efficacy, safety, participants
function and quality of life of each treatment.