Patient Reported Outcome After Surgical Treatment of DDD in Scandinavia

NCT02980822 | Completed

• 1 other identifier: DKMiddelfart4
• Study Type: observational
• Target: 3,500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Diseases; Surgery; Degeneration Disc

Outcome Measures

Primary Outcomes (1)

• Change in Oswestry disability index version 2.1 (from 0; no disability to 100; maximum disability)

  Baseline and 1 year postoperative

Secondary Outcomes (4)

• 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.

  Baseline and 1 year postoperative

• EQ-5D according to the British tariff (UK-TTO; from -0.59; worst possible health to 1; perfect health).

  baseline and 1 year postoperative

• Return to work rate

  Baseline and 1 year postoperative

• Additional surgery in the same segment of the lumbar spine

  During 1 year

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• No history of previous lumbar spine surgery.

Sponsors & Collaborators

• Spine Centre of Southern Denmark: lead

MeSH Terms

Conditions

Spinal Diseases; Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Officials

• Mikkel Ø Andersen, MD

  Sygehus Lilleaelt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Nurse, Head of the national DaneSpine office

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: December 2, 2016
• Study Start: January 1, 2011
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: July 30, 2024

Record last verified: 2024-07