<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01704677</url>
  </required_header>
  <id_info>
    <org_study_id>2011/2177</org_study_id>
    <nct_id>NCT01704677</nct_id>
  </id_info>
  <brief_title>Lumbar Disc Prosthesis Versus Multidisciplinary Rehabilitation; 8-year Follow-up</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St. Olavs Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Haukeland University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Helse Stavanger HF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital of North Norway</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      During the past 25-30 years, surgery with total disc replacement (TDR) has become an option&#xD;
      for a selection of patients with chronic low back pain (LBP) traditionally treated&#xD;
      conservatively or operated on with spinal fusion. Randomized trials comparing TDR with fusion&#xD;
      have found the clinical outcome of TDR at least equivalent to that of fusion, and the only&#xD;
      study comparing TDR to non-surgical treatment (The Norwegian TDR study) concludes that TDR is&#xD;
      significantly more effective than multidisciplinary rehabilitation (REHAB) after 2 years.&#xD;
      However, the long-term effects of TDR in terms of clinical results, costs, reoperation- and&#xD;
      revision rate, degenerative changes and prognostic factors have not been investigated in high&#xD;
      quality prospective trials. This is very much required since TDR surgery is offered a great&#xD;
      number of patients world wide, and is associated with high complexity and risk of serious&#xD;
      complications and difficult revision. Hence, the overall aim of the present study is to&#xD;
      evaluate the long term (eight years follow-up) effect of The Norwegian TDR study where TDR&#xD;
      surgery were compared to modern multidisciplinary rehabilitation in patients with chronic low&#xD;
      back pain and localized degenerative disc changes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Two-year results of the Norwegian TDR study were published in BMJ in May 2011 (Hellum et al).&#xD;
      The current protocol is 8-year follow-up of patients included in the Norwegian TDR study.&#xD;
&#xD;
      Hypothesis of the 8-year follow-up:&#xD;
&#xD;
      Main hypothesis (H0): There are no differences in change between TDR and REHAB for pain and&#xD;
      disability measured by Oswestry Disability Index (main outcome), back pain, quality of life,&#xD;
      psychological variables, work status, patients satisfaction, drug use, urinary incontinence,&#xD;
      and back surgeries after 8 years.&#xD;
&#xD;
      Secondary Hypothesis:&#xD;
&#xD;
        1. There are no differences in incidence and degree of disc degeneration at adjacent level&#xD;
           or facet joint degeneration at index level between groups (radiological analysis).&#xD;
&#xD;
        2. There is no association between baseline characteristics, pelvic anatomy / sagittal&#xD;
           balance (defined by lumbar lordosis, pelvic tilt, pelvic incidence angle and sacral&#xD;
           slope), and clinical outcome after TDR.&#xD;
&#xD;
        3. There is no difference in cost effectiveness between surgery and REHAB 8 years after&#xD;
           inclusion to the study.&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      The investigators will use the same analysis as for 2-years results: two-way ANOVA, mixed&#xD;
      model, regression analysis. p&lt;0.05 will be considered statistically significant&#xD;
&#xD;
      Additional analysis (not conducted at 2 years):&#xD;
&#xD;
        1. cross-overs will receive last value before cross-over/fusion surgery&#xD;
&#xD;
        2. survival analysis&#xD;
&#xD;
        3. pelvic anatomy / sagittal balance (defined by lumbar lordosis, pelvic tilt, pelvic&#xD;
           incidence angle and sacral slope) will be included in the predictor analysis&#xD;
&#xD;
        4. Both CT scans and MRI are taken for the evaluation of index level facet arthropathy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oswestry Disability Index Oswestry Disability Index</measure>
    <time_frame>Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial</time_frame>
    <description>Version 2.0</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Low back pain</measure>
    <time_frame>Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial</time_frame>
    <description>Measured by a VAS scale (0-100 mm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D</measure>
    <time_frame>Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial</time_frame>
    <description>general health status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HSCL-25</measure>
    <time_frame>Baseline, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial</time_frame>
    <description>Hopkins Symptom Check List 25 for emotional distress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work status</measure>
    <time_frame>Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with treatment outcome</measure>
    <time_frame>Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial</time_frame>
    <description>7 point Likert scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with care</measure>
    <time_frame>Baseline, 6 weeks, 3 months, 6 months, 1 and 8 years after inclusion to trial</time_frame>
    <description>5 point Likert scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug consumption</measure>
    <time_frame>Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial</time_frame>
    <description>Daily, weekly, type</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary incontinence</measure>
    <time_frame>Baseline, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial</time_frame>
    <description>Stress incontinence, urge incontinence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Back surgeries and multidisciplinary rehabilitation</measure>
    <time_frame>Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial</time_frame>
    <description>All surgeries and multidisciplinary rehabilitation due to low back pain will be registered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disc degeneration</measure>
    <time_frame>Baseline, 2 and 8 years after inclusion to trial</time_frame>
    <description>Disc degeneration at adjacent level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Facet joint degeneration</measure>
    <time_frame>Baseline, 2 and 8 years after inclusion to trial</time_frame>
    <description>Facet joint degeneration at index level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial</time_frame>
    <description>The EQ-5D questionnaire will be used to estimate patient utilities</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Time to surgery</measure>
    <time_frame>From baseline to 8 years after inclusion to the study</time_frame>
    <description>For patients randomized to TDR surgery: time to fixation&#xD;
For patients randomized to REHAB: time to TDR surgery or fixation</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">151</enrollment>
  <condition>Chronic Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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))</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multidiciplinary rehabilitation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lumbar total disc replacement</intervention_name>
    <description>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.</description>
    <arm_group_label>Surgery</arm_group_label>
    <other_name>ProDisc II, Synthes Spine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Multidisciplinary rehabilitation</intervention_name>
    <description>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.</description>
    <arm_group_label>Multidiciplinary rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 25-55 years&#xD;
&#xD;
          -  had low back pain as the main symptom for at least 1 year&#xD;
&#xD;
          -  structured physiotherapy or chiropractic treatment for at least 6 months without&#xD;
             sufficient effect&#xD;
&#xD;
          -  Oswestry Disability Index (ODI) of at least 30&#xD;
&#xD;
          -  degenerative intervertebral disc changes in L4/L5 and/or L5/S1.Degeneration had to be&#xD;
             restricted to the two lower levels. The following degenerative changes were evaluated:&#xD;
             at least 40% reduction of disc height, Modic changes type I and/or II, high-intensity&#xD;
             zone in the disc, and morphological changes classified as changes in signal intensity&#xD;
             in the disc of grade 3 or 4. The disc was classified as degenerative if the first&#xD;
             criteria alone or at least two changes were found on magnetic resonance imaging. The&#xD;
             discs were independently classified by two observers (orthopaedic surgeon&#xD;
             /radiologist). When in disagreement, the images were classified by a third observer&#xD;
             and the outcome decided by simple majority.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Generalized chronic pain syndrome (widespread myofascial pain)&#xD;
&#xD;
          -  Degeneration established in more than two levels. To be classified as a normal disc,&#xD;
             the disc height must not be reduced more than 40% and all other criteria of&#xD;
             degenerative disc disease aforementioned must be absent. The classification of a&#xD;
             normal disc is performed by two independent observers. If disagreement, the pictures&#xD;
             will be classified by a third observer and the outcome decided by simple majority.&#xD;
&#xD;
          -  Symptoms of spinal stenosis&#xD;
&#xD;
          -  Disc protrusion or recess stenosis with nerve root affection&#xD;
&#xD;
          -  Spondylolysis&#xD;
&#xD;
          -  Isthmic spondylolisthesis&#xD;
&#xD;
          -  Arthritis&#xD;
&#xD;
          -  Former fracture of L1 - S1&#xD;
&#xD;
          -  Ongoing psychiatric or somatic disease that excludes either one or both treatment&#xD;
             alternatives&#xD;
&#xD;
          -  Does not understand Norwegian language, spoken or in writing&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Osteoporosis&#xD;
&#xD;
          -  Congenital or acquired deformity&#xD;
&#xD;
        Patients were examined by an orthopaedic surgeon and a specialist in physical medicine and&#xD;
        rehabilitation together, which had to agree on inclusion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kjersti Storheim, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo University Hospital Ullevål</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oslo University Hospital Ullevål</name>
      <address>
        <city>Oslo</city>
        <zip>0407</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>21596740</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22246644</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22706091</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24150435</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23982421</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23622053</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23307678</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22430564</PMID>
  </reference>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>January 18, 2016</last_update_submitted>
  <last_update_submitted_qc>January 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Kjersti Storheim</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Chronic low back pain</keyword>
  <keyword>Degenerated disc</keyword>
  <keyword>Total disc replacement</keyword>
  <keyword>Multidisciplinary rehabilitation</keyword>
  <keyword>Long term results</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>November 23, 2017</submitted>
    <submission_canceled>July 11, 2018</submission_canceled>
    <submitted>October 12, 2018</submitted>
    <returned>February 20, 2019</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01704677
org study id: 2011/2177
nct id: NCT01704677
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
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.
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Oswestry Disability Index Oswestry Disability Index
time frame: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
description: Version 2.0
measure: Low back pain
time frame: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
description: Measured by a VAS scale (0-100 mm)
measure: EQ-5D
time frame: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
description: general health status
measure: HSCL-25
time frame: Baseline, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
description: Hopkins Symptom Check List 25 for emotional distress
measure: Work status
time frame: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
measure: Satisfaction with treatment outcome
time frame: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
description: 7 point Likert scale
measure: Satisfaction with care
time frame: Baseline, 6 weeks, 3 months, 6 months, 1 and 8 years after inclusion to trial
description: 5 point Likert scale
measure: Drug consumption
time frame: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
description: Daily, weekly, type
measure: Urinary incontinence
time frame: Baseline, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
description: Stress incontinence, urge incontinence
measure: Back surgeries and multidisciplinary rehabilitation
time frame: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
description: All surgeries and multidisciplinary rehabilitation due to low back pain will be registered
measure: Disc degeneration
time frame: Baseline, 2 and 8 years after inclusion to trial
description: Disc degeneration at adjacent level
measure: Facet joint degeneration
time frame: Baseline, 2 and 8 years after inclusion to trial
description: Facet joint degeneration at index level
measure: Cost-effectiveness
time frame: Baseline, 6 weeks, 3 months, 6 months, 1, 2 and 8 years after inclusion to trial
description: The EQ-5D questionnaire will be used to estimate patient utilities
measure: Time to surgery
time frame: From baseline to 8 years after inclusion to the study
description: For patients randomized to TDR surgery: time to fixation
For patients randomized to REHAB: time to TDR surgery or fixation
arm group label: Surgery
arm group type: Experimental
description: 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))
arm group label: Multidiciplinary rehabilitation
arm group type: Active Comparator
intervention type: Procedure
intervention name: Lumbar total disc replacement
description: 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.
arm group label: Surgery
other name: ProDisc II, Synthes Spine
intervention type: Behavioral
intervention name: Multidisciplinary rehabilitation
description: 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.
arm group label: Multidiciplinary rehabilitation
criteria: 
gender: All
minimum age: 25 Years
maximum age: 55 Years
healthy volunteers: No
last name: Kjersti Storheim, PhD
role: Principal Investigator
affiliation: Oslo University Hospital Ullevål
facility: 
country: Norway
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Kjersti Storheim
investigator title: PhD
mesh term: Back Pain
mesh term: Low Back Pain
submitted: November 23, 2017
submission canceled: July 11, 2018
submitted: October 12, 2018
returned: February 20, 2019