151
Participants
Start Date
September 30, 2012
Primary Completion Date
November 30, 2015
Study Completion Date
November 30, 2015
Lumbar total disc replacement
The surgical intervention consisted of replacement of the degenerative intervertebral lumbar disc with a artificial lumbar disc device in one or two of the lover lumbal levels (L4/L5 or/and L5/S1). The ProDisc consists of three pieces, two metal endplates and a polyethylene core that is fixed to the inferior endplate when the device is implanted, and is implanted through a retroperitoneal (or transperitoneal) access.
Multidisciplinary rehabilitation
The intervention is based on a treatment model described by Brox et al (Spine 2003;28:1913-1921) and is also described in details by Hellum et al (BMJ, May 2011). It consisted of a cognitive approach and supervised physical exercise and was delivered by a team of physiotherapists and specialists in physical medicine and rehabilitation. The rehabilitation programme lasted for about 60 hours over three to five weeks.
Oslo University Hospital Ullevål, Oslo
St. Olavs Hospital
OTHER
Haukeland University Hospital
OTHER
Helse Stavanger HF
OTHER_GOV
University Hospital of North Norway
OTHER
Oslo University Hospital
OTHER