We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Patient Reported Outcome After Surgical Treatment of DDD in Scandinavia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02980822
Recruitment Status : Active, not recruiting
First Posted : December 2, 2016
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Purpose: The incidence of surgery for Degenerative lumbar Disc Disease (DDD). According to the national spine registries in Sweden, Norway and Denmark, there is a difference in surgical incidence between these countries. The cause for this difference is not known. It may reflect a difference in incidence of lumbar disc hernia, but with a similar socio-economic and ethnical background in these countries, it is more likely that the differences are due to varying surgical indications. Comparing indications for surgery, patient reported outcome and factors predictive for outcome after surgery for lumbar disc decease in these countries could provide information about optimal indications for surgery.

Hypotheses: (i) there are no differences in patient-reported outcome after surgery between these countries, (ii) there are no differences in indications for surgery between these countries and (iii), factors that predict outcome are similar in these countries.

Method of research: By using data from three Nordic national spine registers, investigators will compare baseline data, indications for surgery and patient reported outcome one year after surgery for lumbar disc decease. Register based studies have advantages such as large sample sizes, reflecting real life, but they also have limitations such as lower follow-up rates than clinical trials. A non-response analysis will be performed to take this into account.


Condition or disease
Spinal Diseases Surgery Degeneration Disc

  Show Detailed Description

Study Design

Study Type : Observational [Patient Registry]
Actual Enrollment : 3500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Comparison of Baseline Characteristics and Patient Reported Outcome After Surgical Treatment of Degenerative Lumbar Disc Disease in Scandinavia
Study Start Date : January 2011
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Sweden, Denmark, Norway

Group: Degenerative lumbar disc disease patients treated in Sweden and included in the Swespine register

Group: Degenerative lumbar disc disease patients treated in Norway and included in the NORspine register

Group: Degenerative lumbar disc disease patients treated in Denmark and included in the DaneSpine register



Outcome Measures

Primary Outcome Measures :
  1. Change in Oswestry disability index version 2.1 (from 0; no disability to 100; maximum disability) [ Time Frame: Baseline and 1 year postoperative ]

Secondary Outcome Measures :
  1. Numerical rating scale for leg pain (from 0; no pain to 10; maximum pain) . The numerical rating scale is used in Norway. The visual analogue scale (0-100) used in Sweden and Denmark will be converted to the numerical rating scale. [ Time Frame: Baseline and 1 year postoperative ]
  2. EQ-5D according to the British tariff (UK-TTO; from -0.59; worst possible health to 1; perfect health). [ Time Frame: baseline and 1 year postoperative ]
  3. Return to work rate [ Time Frame: Baseline and 1 year postoperative ]
    Preoperative and postoperative work rate

  4. Additional surgery in the same segment of the lumbar spine [ Time Frame: During 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Included are individuals treated surgically for DDD between the ages of 18 through 65 years. Surgery has been performed in Denmark, Norway or Sweden during 2011, 2012 or 2013
Criteria

Inclusion Criteria:

  • All patients operated due to DDD in the Scandinavian countries during 2011, 2012 or 2013

Exclusion Criteria:

No history of previous lumbar spine surgery.

Contacts and Locations

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): NCT02980822


Sponsors and Collaborators
Sygehus Lillebaelt
Investigators
Principal Investigator: Mikkel Ø Andersen, MD Sygehus Lilleaelt
More Information

Responsible Party: Karen Hoejmark Hansen, Research Nurse, Head of the national DaneSpine office, Sygehus Lillebaelt
ClinicalTrials.gov Identifier: NCT02980822     History of Changes
Other Study ID Numbers: DKMiddelfart4
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Spinal Diseases
Intervertebral Disc Degeneration
Bone Diseases
Musculoskeletal Diseases