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Posterior decompression and fusion in patients with multi-level cervical spondylotic myelopathy

Organizational Data

DRKS-ID:
DRKS00014285
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2018-03-14
Last update in DRKS:
2018-03-14
Registration type:
Retrospective

Acronym/abbreviation of the study

No Entry

URL of the study

No Entry

Brief summary in lay language

In cervical spinal canal stenosis, there is a narrowing (stenosis) of the bony canal in the area of the cervical spine, where the spinal cord is located. A narrowing of this channel can lead to damage to the spinal cord (myelopathy). Symptoms of myelopathy include feelings or impairments in the arms and legs, walking difficulties or problems with urination and bowel movements or sexual dysfunctions. The spinal stenosis is usually due to the advancing age of the patient (degenerative). Occasionally, the stenosis does not only occur on one single movement segment of the cervical spine (monosegmental), but affects several segments (multisegmental). In a multisegmental cervical spinal canal stenosis with appropriate clinical symptoms, a relief of the spinal cord from the neck (posterior), may be necessary with subsequent stabilization of the bony structures with a screw and rod system (spinal fusion). This procedure has been routinely performed in our department for over ten years. Nevertheless, it is a complex, several-hour intervention. Due to the necessary stabilization of the cervical spine over several movement segments, there is also a permanent restriction of movement after the operation. The aim of this research project is to retrospectively record the peri-and short-term postoperative course of treatment of patients undergoing degenerative, multisegmental cervical spinal canal stenosis by multi-level posterior spondylodesis from 2004 to 2016, as well as to collect data on long-term outcome and current findings by evaluating the patients in our out-patient clinic or by sending questionnaires or via telephone interviews.

Brief summary in scientific language

If there are already significant clinical signs of spinal cord injury due to cervical spinal stenosis, surgical treatment is recommended (1,2). If there is a narrowing of the spinal canal over three or more segments, posterior decompression of the spinal cord can be performed, followed by stabilization of the bony structures via a screw-rod system (3). Alternatives to this surgical technique are e.g. laminoplasty or anterior approaches. In laminoplasty, the bony structures are reinserted after decompression and fixed for example with small metal plates and screws to avoid the use of a screw-rod system. In the anterior approach, the relief of the spinal cord is achieved via multi-level discectomies with subsequent insertion of intervertebral placeholders (Cage) and possibly also plate / screw systems. So far, there is no agreement on the optimal treatment method in the literature (4,5). 1. Fehlings MG, Wilson JR, Yoon ST, Rhee JM, Shamji MF, Lawrence BD. Symptomatic progression of cervical myelopathy and the role of nonsurgical management: a consensus statement. Spine (Phila Pa 1976). 2013; 38: S19-S20. 2nd Karadimas SK, Erwin WM, Ely CG, Dettori JR, Fehlings MG. Pathophysiology and natural history of cervical spondylotic myelopathy. Spine (Phila Pa 1976). 2013; 38: S21-S36. 3. Cabraja M, Abbushi A, Koeppen D, Kroppenstedt S, Woiciechowsky C. Comparison between anterior and posterior decompression with instrumentation for cervical spondylotic myelopathy: sagittal alignment and clinical outcome. Neurosurgical Focus. 2010; 28: E15. 4. Lawrence BD, Jacobs WB, Norvell DC, Hermsmeyer JT, Chapman JR, Brodke DS. Anterior versus posterior approach to cervical spondylotic myelopathy treatment: a systematic review. Spine. 2013; 38: S173-S182. 5. Farrokhi MR, Ghaffarpasand F, Khani M, Gholami M. Evidence-Based Stepwise Surgical Approach to Cervical Spondylotic Myelopathy: A Narrative Review of the Current Literature. World Neurosurg. (2016) 94: 97-110.

Health condition or problem studied

ICD10:
M47.12
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Patients ≥ 18 years with degenerative, multi-level, cervical spondylotic myelopathy surgically treated with multi-level posterior decompression and fusion over the period of 2004-2016. The postoperative course of treatment is recorded retrospectively, and long-term data and current findings are collected via appointments to the outpatient clinic or by sending questionnaires or telephone interviews.

Endpoints

Primary outcome:
Major complications occuring within 30 days after posterior decompression and fusion in patients with multi-level cervical spondylotic myelopathy: death, myocardial infarction, vertebral artery injury, insult, pulmonary embolism, severe pneumonia with respiratory care, reoperation, new motor deficit KG ≤ 3/5. Incidence of complications in the further postoperative course (e.g., revision surgery). The postoperative complications are retrospectively collected from medical records. Current Cervical Spine Disorders / Pain on the numeric rating scale (NRS). The current complaints are collected in the outpatient clinic or via questionnaires or telephone interviews. Objective measurement of parameters of cervical spine mobility (inclination, reclination, lateral tilt, and rotation). For the objective measurement, a non-invasive measuring device (CROM3, Performance Attainment Associates), which has already been validated in several studies, is used.
Secondary outcome:
Minor complications occurring within 30 days after posterior decompression and fusion in patients with multi-level cervical spondylotic myelopathy: new motor deficit KG> 3/5, mild pneumonia with transient oxygen demand, postoperative confusion, urinary tract infection, transfusion-dependent anemia, deep vein thrombosis, hepatic insufficiency, dural lesion / CSF fistula. The postoperative complications are retrospectively collected from medical records. Subjective restriction of movement, information on quality of life and impairment in everyday life (e.g. driving), patient satisfaction. The current complaints are collected in the outpatient clinic or via questionnaires or telephone interviews.

Study Design

Purpose:
Treatment
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Klinik für Neurochirurgie Freiburg im Breisgau

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2018-01-01
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
100
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
Patients ≥ 18 years with multi-level cervical spondylotic myelopathy treated surgically with multi-level posterior decompression and fusion over the period 2004-2016.

Exclusion Criteria

Patients <18 years. For measurement of cervical range of motion in outpatient examination: Uncooperative patients; Patients who can not sit on an examination chair due to other physical limitations; Patient with pacemaker and defibrillator.

Addresses

Primary Sponsor

Address:
Universitätsklinikum Freiburg
Hugstetter Strasse 49
79095 Freiburg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.uniklinik-freiburg.de
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Address:
Klinik für Neurochirurgie Universitätsklinikum Freiburg
Dr. Christoph Scholz
Breisacher Str. 64
79106 Freiburg
Germany
Telephone:
076127050010
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.uniklinik-freiburg.de

Contact for Public Queries

Address:
Klinik für Neurochirurgie Universitätsklinikum Freiburg
Dr. Christoph Scholz
Breisacher Str. 64
79106 Freiburg
Germany
Telephone:
076127050010
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.uniklinik-freiburg.de

Principal Investigator

Address:
Klinik für Neurochirurgie Universitätsklinikum Freiburg
Dr. Christoph Scholz
Breisacher Str. 64
79106 Freiburg
Germany
Telephone:
076127050010
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.uniklinik-freiburg.de

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Address:
Klinik für Neurochirurgie Universitätsklinikum Freiburg
Breisacher Str. 64
79106 Freiburg
Germany
Telephone:
076127050010
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.uniklinik-freiburg.de

Ethics Committee

Address Ethics Committee

Address:
Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
Engelberger Str. 21
79106 Freiburg
Germany
Telephone:
+49-761-27072600
Fax:
+49-761-27072630
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Vote of leading Ethics Committee
Date of ethics committee application:
2017-09-18
Ethics committee number:
465/17
Vote of the Ethics Committee:
Approved
Date of the vote:
2017-11-07

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
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Study abstract:
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Other study documents:
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Background literature:
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Related DRKS studies:
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Publication of study results

Planned publication:
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Publikationen/Studienergebnisse:
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Date of first publication of study results:
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DRKS entry published for the first time with results:
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Basic reporting

Basic Reporting / Results tables:
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Brief summary of results:
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