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

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ClinicalTrials.gov Identifier: NCT01704677
Recruitment Status : Completed
First Posted : October 11, 2012
Last Update Posted : January 20, 2016
Sponsor:
Collaborators:
St. Olavs Hospital
Haukeland University Hospital
Helse Stavanger HF
University Hospital of North Norway
Information provided by (Responsible Party):
Kjersti Storheim, Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Procedure: Lumbar total disc replacement Behavioral: Multidisciplinary rehabilitation Not Applicable

Detailed Description:

Two-year results of the Norwegian TDR study were published in BMJ in May 2011 (Hellum et al). The current protocol is 8-year follow-up of patients included in the Norwegian TDR study.

Hypothesis of the 8-year follow-up:

Main hypothesis (H0): There are no differences in change between TDR and REHAB for pain and disability measured by Oswestry Disability Index (main outcome), back pain, quality of life, psychological variables, work status, patients satisfaction, drug use, urinary incontinence, and back surgeries after 8 years.

Secondary Hypothesis:

  1. There are no differences in incidence and degree of disc degeneration at adjacent level or facet joint degeneration at index level between groups (radiological analysis).
  2. There is no association between baseline characteristics, pelvic anatomy / sagittal balance (defined by lumbar lordosis, pelvic tilt, pelvic incidence angle and sacral slope), and clinical outcome after TDR.
  3. There is no difference in cost effectiveness between surgery and REHAB 8 years after inclusion to the study.

Statistical analysis:

The investigators will use the same analysis as for 2-years results: two-way ANOVA, mixed model, regression analysis. p<0.05 will be considered statistically significant

Additional analysis (not conducted at 2 years):

  1. cross-overs will receive last value before cross-over/fusion surgery
  2. survival analysis
  3. pelvic anatomy / sagittal balance (defined by lumbar lordosis, pelvic tilt, pelvic incidence angle and sacral slope) will be included in the predictor analysis
  4. Both CT scans and MRI are taken for the evaluation of index level facet arthropathy

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lumbar Disc Prosthesis Versus Multidisciplinary Rehabilitation in Chronic Back Pain and Localized Degenerative Disc. Long Term Follow-up of a Randomized Multicentre Trial
Study Start Date : September 2012
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Surgery
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
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.
Other Name: ProDisc II, Synthes Spine

Active Comparator: Multidiciplinary rehabilitation 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.




Primary Outcome Measures :
  1. Oswestry Disability Index Oswestry Disability Index [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial ]
    Version 2.0


Secondary Outcome Measures :
  1. Low back pain [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial ]
    Measured by a VAS scale (0-100 mm)

  2. EQ-5D [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial ]
    general health status

  3. HSCL-25 [ Time Frame: Baseline, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial ]
    Hopkins Symptom Check List 25 for emotional distress

  4. Work status [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial ]
  5. Satisfaction with treatment outcome [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial ]
    7 point Likert scale

  6. Satisfaction with care [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 1 and 8 years after inclusion to trial ]
    5 point Likert scale

  7. Drug consumption [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial ]
    Daily, weekly, type

  8. Urinary incontinence [ Time Frame: Baseline, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial ]
    Stress incontinence, urge incontinence

  9. Back surgeries and multidisciplinary rehabilitation [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial ]
    All surgeries and multidisciplinary rehabilitation due to low back pain will be registered

  10. Disc degeneration [ Time Frame: Baseline, 2 and 8 years after inclusion to trial ]
    Disc degeneration at adjacent level

  11. Facet joint degeneration [ Time Frame: Baseline, 2 and 8 years after inclusion to trial ]
    Facet joint degeneration at index level

  12. Cost-effectiveness [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial ]
    The EQ-5D questionnaire will be used to estimate patient utilities


Other Outcome Measures:
  1. Time to surgery [ Time Frame: From baseline to 8 years after inclusion to the study ]

    For patients randomized to TDR surgery: time to fixation

    For patients randomized to REHAB: time to TDR surgery or fixation




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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Patients were examined by an orthopaedic surgeon and a specialist in physical medicine and rehabilitation together, which had to agree on inclusion.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704677


Locations
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Norway
Oslo University Hospital Ullevål
Oslo, Norway, 0407
Sponsors and Collaborators
Oslo University Hospital
St. Olavs Hospital
Haukeland University Hospital
Helse Stavanger HF
University Hospital of North Norway
Investigators
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Principal Investigator: Kjersti Storheim, PhD Oslo University Hospital Ullevål

Publications:

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Responsible Party: Kjersti Storheim, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01704677     History of Changes
Other Study ID Numbers: 2011/2177
First Posted: October 11, 2012    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016
Keywords provided by Kjersti Storheim, Oslo University Hospital:
Chronic low back pain
Degenerated disc
Total disc replacement
Multidisciplinary rehabilitation
Long term results
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms