NCT01865942

Brief Summary

The investigators wish to evaluate the effect of minimal access spinal surgery compared to traditional open surgery spinal surgery in patients with metastatic spinal cord compression. Minimal access surgery has been shown to bee less damaging for the tissue compared to traditional open surgery and also cause fewer wound complications, the investigators expect the above could have impact in a vulnerable patient group like patients with metastatic spinal cord compression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 31, 2013

Completed
1.2 years until next milestone

Study Start

First participant enrolled

August 28, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2017

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

2.4 years

First QC Date

April 4, 2013

Last Update Submit

March 30, 2017

Conditions

Spinal Metastases

Keywords

spinal metastasesspine surgerymetastatic spinal cord compressionEQ-5DHRQOL

Outcome Measures

Primary Outcomes (1)

  • Bleeding

    The investigators compare the bleeding for each treatment modality during the operation.

    intraoperative

Secondary Outcomes (1)

  • Health related quality of life measured with questionnaire EQ-5D and QLQ-C30

    before intervention and six months follow up

Study Arms (2)

open surgery

ACTIVE COMPARATOR

One arm receives open surgery. In our department open surgery is considered as the standard procedure since all spine surgeons are preforming this operation.

Procedure: open surgery

Minimal access surgery

ACTIVE COMPARATOR

We compare to well-known types of surgery for metastatic spinal cord compression. The other arm receive open surgery. In our department minimal access surgery is considered as a standard procedure but it is not preformed by all spine surgeons.

Procedure: Minimal access surgery

Interventions

open surgeryPROCEDURE

The to surgical procedures are individually well know, but the outcome of the procedures in respect to perioperative bleeding and change in quality of life has to our knowledge not been compared.

open surgery
Minimal access surgeryPROCEDURE

The to surgical procedures are individually well know, but the outcome of the procedures in respect to perioperative bleeding and change in quality of life has to our knowledge not been compared.

Minimal access surgery

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Metastatic spinal cord compression with a metastasis from Th5-L3 Tokuhashi above 4

You may not qualify if:

  • Need for radical treatment and not only palliative
  • Need for surgical stabilization in a region lower then L3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Copenhagen, 2100, Denmark

Location

Related Publications (4)

  • Rodriguez-Vela J, Lobo-Escolar A, Joven-Aliaga E, Herrera A, Vicente J, Sunen E, Loste A, Tabuenca A. Perioperative and short-term advantages of mini-open approach for lumbar spinal fusion. Eur Spine J. 2009 Aug;18(8):1194-201. doi: 10.1007/s00586-009-1010-0. Epub 2009 Apr 28.

    PMID: 19399538BACKGROUND

  • Falicov A, Fisher CG, Sparkes J, Boyd MC, Wing PC, Dvorak MF. Impact of surgical intervention on quality of life in patients with spinal metastases. Spine (Phila Pa 1976). 2006 Nov 15;31(24):2849-56. doi: 10.1097/01.brs.0000245838.37817.40.

    PMID: 17108840BACKGROUND

  • Kim KT, Lee SH, Suk KS, Bae SC. The quantitative analysis of tissue injury markers after mini-open lumbar fusion. Spine (Phila Pa 1976). 2006 Mar 15;31(6):712-6. doi: 10.1097/01.brs.0000202533.05906.ea.

    PMID: 16540878BACKGROUND

  • Ringel F, Stoffel M, Stuer C, Meyer B. Minimally invasive transmuscular pedicle screw fixation of the thoracic and lumbar spine. Neurosurgery. 2006 Oct;59(4 Suppl 2):ONS361-6; discussion ONS366-7. doi: 10.1227/01.NEU.0000223505.07815.74.

    PMID: 17041505BACKGROUND

MeSH Terms

Conditions

Spinal Cord Compression

Interventions

Conversion to Open Surgery

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

EndoscopyMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Søren Schmidt Morgen, MD

    Spine Section, Department of Orthopedic Surgery, Copenhagen University Hospital, Rigshospitalet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

April 4, 2013

First Posted

May 31, 2013

Study Start

August 28, 2014

Primary Completion

January 2, 2017

Study Completion

March 30, 2017

Last Updated

April 4, 2017

Record last verified: 2017-03

Locations

DK(1)