Outcome of Surgery for Sciatica - a Comparison of Data From Three National Quality Registries

NCT02889484 | Completed

• 1 other identifier: 1
• Study Type: observational
• Target: 7,500
• Locations: 0 countries
• Sites: N/A

Brief Summary

Purpose: The incidence of surgery for lumbar disc hernia varies. According to the national spine registries in Sweden, Norway and Denmark, there is a 30-60% 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 hernia 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, we will compare baseline data, indications for surgery and patient reported outcome one year after surgery for lumbar disc herniation. 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

Intervertebral Disc Displacement; Sciatica

Outcome Measures

Primary Outcomes (1)

• Oswestry disability index

  Index at baseline, index change from preoperative to 1 year follow-up and actual index at 1 year follow-up. Oswestry disability index version 2.1 (from 0; no disability to 100; maximum disability)

  preoperative and 1 year postoperative

Secondary Outcomes (5)

• Numerical rating scale for leg pain

  preoperative and 1 year postoperative

• Numerical rating scale for back pain

  preoperative and 1 year postoperative

• EQ-5D

  preoperative and 1 year postoperative

• Return to work rate

  Preoperative work rate. Work rate at the 1 year follow-up.

• Additional surgery in the same segment of the lumbar spine

  During the 1 year follow-up

Study Arms (3)

Disc hernia patients treated in Sweden

Individuals undergoing lumbar disc hernia surgery and included in the Swespine register

Procedure: Lumbar disc hernia surgery

Disc hernia patients treated in Norway

Individuals undergoing lumbar disc hernia surgery and included in the NORspine register

Procedure: Lumbar disc hernia surgery

Disc hernia patients treated in Denmark

Individuals undergoing lumbar disc hernia surgery and included in the Danespine register

Procedure: Lumbar disc hernia surgery

Interventions

Lumbar disc hernia surgery PROCEDURE

Also known as: Surgery for sciatica due to lumbar disc herniation

Disc hernia patients treated in Denmark; Disc hernia patients treated in Norway; Disc hernia patients treated in Sweden

Eligibility Criteria

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

Study Population

This is an observational register based study, with prospective data registration and with a retrospective study design. Individuals treated surgically for lumbar disc herniation in Denmark, Norway and Sweden during 2011, 2012 and 2013 are included.

You may qualify if:

• Patients treated with surgery for lumbar disc herniation in Denmark, Sweden or Norway and registered in a national quality register.

You may not qualify if:

• Patients not treated with discectomy for the lumbar disc herniation.

Sponsors & Collaborators

• Karolinska Institutet: lead

Related Publications (2)

• Hojmark K, Stottrup C, Carreon L, Andersen MO. Patient-reported outcome measures unbiased by loss of follow-up. Single-center study based on DaneSpine, the Danish spine surgery registry. Eur Spine J. 2016 Jan;25(1):282-286. doi: 10.1007/s00586-015-4127-3. Epub 2015 Jul 25.

  PMID: 26208938 BACKGROUND

• Solberg TK, Sorlie A, Sjaavik K, Nygaard OP, Ingebrigtsen T. Would loss to follow-up bias the outcome evaluation of patients operated for degenerative disorders of the lumbar spine? Acta Orthop. 2011 Feb;82(1):56-63. doi: 10.3109/17453674.2010.548024. Epub 2010 Dec 29.

  PMID: 21189113 BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Displacement; Sciatica

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Paul Gerdhem, MD, PhD

  Karolinska University Hospital and Karolinska Institutet, K54, Huddinge, SE-141 86 Stockholm, Sweden

  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: MD, PhD, Assoc Prof

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: September 5, 2016
• Study Start: January 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2015
• Last Updated: December 5, 2017

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share