Lumbar Disc Prosthesis Versus Multidisciplinary Rehabilitation; 8-year Follow-up

NACompletedINTERVENTIONAL
Enrollment

151

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

November 30, 2015

Study Completion Date

November 30, 2015

Conditions
Chronic Low Back Pain
Interventions
PROCEDURE

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.

BEHAVIORAL

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.

Trial Locations (1)

0407

Oslo University Hospital Ullevål, Oslo

All Listed Sponsors
collaborator

St. Olavs Hospital

OTHER

collaborator

Haukeland University Hospital

OTHER

collaborator

Helse Stavanger HF

OTHER_GOV

collaborator

University Hospital of North Norway

OTHER

lead

Oslo University Hospital

OTHER

NCT01704677 - Lumbar Disc Prosthesis Versus Multidisciplinary Rehabilitation; 8-year Follow-up | Biotech Hunter | Biotech Hunter