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

NCT01704677 | Completed DMC

• 1 other identifier: 2011/2177
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

During the past 25-30 years, surgery with total disc replacement (TDR) has become an option for a selection of patients with chronic low back pain (LBP) traditionally treated conservatively or operated on with spinal fusion. Randomized trials comparing TDR with fusion have found the clinical outcome of TDR at least equivalent to that of fusion, and the only study comparing TDR to non-surgical treatment (The Norwegian TDR study) concludes that TDR is significantly more effective than multidisciplinary rehabilitation (REHAB) after 2 years. However, the long-term effects of TDR in terms of clinical results, costs, reoperation- and revision rate, degenerative changes and prognostic factors have not been investigated in high quality prospective trials. This is very much required since TDR surgery is offered a great number of patients world wide, and is associated with high complexity and risk of serious complications and difficult revision. Hence, the overall aim of the present study is to evaluate the long term (eight years follow-up) effect of The Norwegian TDR study where TDR surgery were compared to modern multidisciplinary rehabilitation in patients with chronic low back pain and localized degenerative disc changes.

Conditions

Chronic Low Back Pain

Keywords

Chronic low back pain; Degenerated disc; Total disc replacement; Multidisciplinary rehabilitation; Long term results

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index Oswestry Disability Index

  Version 2.0

  Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial

Secondary Outcomes (12)

• Low back pain

  Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial

• EQ-5D

  Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial

• HSCL-25

  Baseline, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial

• Work status

  Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial

• Satisfaction with treatment outcome

  Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial

Other Outcomes (1)

• Time to surgery

  From baseline to 8 years after inclusion to the study

Study Arms (2)

Surgery

EXPERIMENTAL

Replacement of the degenerative intervertebral lumbar disc with an artificial lumbar disc device (degeneration had to be restricted to the two lower levels (L4/L5 and/or L5/S1))

Procedure: Lumbar total disc replacement

Multidiciplinary rehabilitation

ACTIVE COMPARATOR

Behavioral: Multidisciplinary rehabilitation

Interventions

Lumbar total disc replacement PROCEDURE

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.

Also known as: ProDisc II, Synthes Spine

Surgery

Multidisciplinary rehabilitation BEHAVIORAL

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.

Multidiciplinary rehabilitation

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• aged 25-55 years
• had low back pain as the main symptom for at least 1 year
• structured physiotherapy or chiropractic treatment for at least 6 months without sufficient effect
• Oswestry Disability Index (ODI) of at least 30
• degenerative intervertebral disc changes in L4/L5 and/or L5/S1.Degeneration had to be restricted to the two lower levels. The following degenerative changes were evaluated: at least 40% reduction of disc height, Modic changes type I and/or II, high-intensity zone in the disc, and morphological changes classified as changes in signal intensity in the disc of grade 3 or 4. The disc was classified as degenerative if the first criteria alone or at least two changes were found on magnetic resonance imaging. The discs were independently classified by two observers (orthopaedic surgeon /radiologist). When in disagreement, the images were classified by a third observer and the outcome decided by simple majority.

You may not qualify if:

• Generalized chronic pain syndrome (widespread myofascial pain)
• Degeneration established in more than two levels. To be classified as a normal disc, the disc height must not be reduced more than 40% and all other criteria of degenerative disc disease aforementioned must be absent. The classification of a normal disc is performed by two independent observers. If disagreement, the pictures will be classified by a third observer and the outcome decided by simple majority.
• Symptoms of spinal stenosis
• Disc protrusion or recess stenosis with nerve root affection
• Spondylolysis
• Isthmic spondylolisthesis
• Arthritis
• Former fracture of L1 - S1
• Ongoing psychiatric or somatic disease that excludes either one or both treatment alternatives
• Does not understand Norwegian language, spoken or in writing
• Drug abuse
• Osteoporosis
• Congenital or acquired deformity

Sponsors & Collaborators

• Oslo University Hospital: lead
• St. Olavs Hospital: collaborator
• Haukeland University Hospital: collaborator
• Helse Stavanger HF: collaborator
• University Hospital of North Norway: collaborator

Study Sites (1)

Oslo University Hospital Ullevål

Oslo, Oslo County, 0407, Norway

Location

Related Publications (9)

• Hellum C, Johnsen LG, Storheim K, Nygaard OP, Brox JI, Rossvoll I, Ro M, Sandvik L, Grundnes O; Norwegian Spine Study Group. Surgery with disc prosthesis versus rehabilitation in patients with low back pain and degenerative disc: two year follow-up of randomised study. BMJ. 2011 May 19;342:d2786. doi: 10.1136/bmj.d2786.

  PMID: 21596740 BACKGROUND

• Hellum C, Johnsen LG, Gjertsen O, Berg L, Neckelmann G, Grundnes O, Rossvoll I, Skouen JS, Brox JI, Storheim K; Norwegian Spine Study Group. Predictors of outcome after surgery with disc prosthesis and rehabilitation in patients with chronic low back pain and degenerative disc: 2-year follow-up. Eur Spine J. 2012 Apr;21(4):681-90. doi: 10.1007/s00586-011-2145-3. Epub 2012 Jan 13.

  PMID: 22246644 BACKGROUND

• Hellum C, Berg L, Gjertsen O, Johnsen LG, Neckelmann G, Storheim K, Keller A, Grundnes O, Espeland A; Norwegian Spine Study Group. Adjacent level degeneration and facet arthropathy after disc prosthesis surgery or rehabilitation in patients with chronic low back pain and degenerative disc: second report of a randomized study. Spine (Phila Pa 1976). 2012 Dec 1;37(25):2063-73. doi: 10.1097/BRS.0b013e318263cc46.

  PMID: 22706091 BACKGROUND

• Johnsen LG, Hellum C, Storheim K, Nygaard OP, Brox JI, Rossvoll I, Ro M, Andresen H, Lydersen S, Grundnes O, Pedersen M, Leivseth G, Olafsson G, Borgstrom F, Fritzell P; Norwegian Spine Study Group. Cost-effectiveness of total disc replacement versus multidisciplinary rehabilitation in patients with chronic low back pain: a Norwegian multicenter RCT. Spine (Phila Pa 1976). 2014 Jan 1;39(1):23-32. doi: 10.1097/BRS.0000000000000065.

  PMID: 24150435 BACKGROUND

• Berg L, Hellum C, Gjertsen O, Neckelmann G, Johnsen LG, Storheim K, Brox JI, Eide GE, Espeland A; Norwegian Spine Study Group. Do more MRI findings imply worse disability or more intense low back pain? A cross-sectional study of candidates for lumbar disc prosthesis. Skeletal Radiol. 2013 Nov;42(11):1593-602. doi: 10.1007/s00256-013-1700-x. Epub 2013 Aug 28.

  PMID: 23982421 BACKGROUND

• Johnsen LG, Hellum C, Nygaard OP, Storheim K, Brox JI, Rossvoll I, Leivseth G, Grotle M. Comparison of the SF6D, the EQ5D, and the oswestry disability index in patients with chronic low back pain and degenerative disc disease. BMC Musculoskelet Disord. 2013 Apr 26;14:148. doi: 10.1186/1471-2474-14-148.

  PMID: 23622053 BACKGROUND

• Johnsen LG, Brinckmann P, Hellum C, Rossvoll I, Leivseth G. Segmental mobility, disc height and patient-reported outcomes after surgery for degenerative disc disease: a prospective randomised trial comparing disc replacement and multidisciplinary rehabilitation. Bone Joint J. 2013 Jan;95-B(1):81-9. doi: 10.1302/0301-620X.95B1.29829.

  PMID: 23307678 BACKGROUND

• Berg L, Gjertsen O, Hellum C, Neckelmann G, Johnsen LG, Eide GE, Espeland A. Reliability of change in lumbar MRI findings over time in patients with and without disc prosthesis--comparing two different image evaluation methods. Skeletal Radiol. 2012 Dec;41(12):1547-57. doi: 10.1007/s00256-012-1394-5. Epub 2012 Mar 20.

  PMID: 22430564 BACKGROUND

• Garratt AM, Furunes H, Hellum C, Solberg T, Brox JI, Storheim K, Johnsen LG. Evaluation of the EQ-5D-3L and 5L versions in low back pain patients. Health Qual Life Outcomes. 2021 May 28;19(1):155. doi: 10.1186/s12955-021-01792-y.

  PMID: 34049574 DERIVED

Study Officials

• Kjersti Storheim, PhD

  Oslo University Hospital Ullevål

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: October 2, 2012
• First Posted: October 11, 2012
• Study Start: September 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 20, 2016

Record last verified: 2016-01

Locations

NO (1)