Patient Reported Outcome After Surgical Treatment of DDD in Scandinavia
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|ClinicalTrials.gov Identifier: NCT02980822|
Recruitment Status : Active, not recruiting
First Posted : December 2, 2016
Last Update Posted : December 5, 2016
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 Type :||Observational [Patient Registry]|
|Actual Enrollment :||3500 participants|
|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|
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
- Change in Oswestry disability index version 2.1 (from 0; no disability to 100; maximum disability) [ Time Frame: Baseline and 1 year postoperative ]
- 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 ]
- 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 ]
- Return to work rate [ Time Frame: Baseline and 1 year postoperative ]Preoperative and postoperative work rate
- Additional surgery in the same segment of the lumbar spine [ Time Frame: During 1 year ]
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
|Principal Investigator:||Mikkel Ø Andersen, MD||Sygehus Lilleaelt|