NCT01495143

Brief Summary

Paraspinal muscle damage is inevitable during conventional posterior lumbar fusion surgery. Minimal invasive surgery is postulated to result in less muscle damage and better outcome. The aim of this study is to monitor metabolic changes of the paraspinal muscle and to evaluate paraspinal muscle damage during surgery using microdialysis (MD).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2007

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

Study Start

First participant enrolled

January 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2009

Completed
2 years until next milestone

First Posted

Study publicly available on registry

December 19, 2011

Completed
Last Updated

September 15, 2014

Status Verified

September 1, 2014

Enrollment Period

11 months

First QC Date

December 29, 2009

Last Update Submit

September 12, 2014

Conditions

Trauma

Keywords

GlucoseLactate pyruvate ratioGlycerolParaspinal muscleMicrodialysis

Outcome Measures

Primary Outcomes (1)

  • The glycerol concentration

    To study whether the glucerol concentration can be used to evaluate surgery related paraspinal muscle damage

    Two hours

Study Arms (2)

Healthy group

ACTIVE COMPARATOR

Eight healthy volunteers (five males and three females) with a body mass index of 23.8 and without chronic metabolic disease or low back pain. They are all non-smokers and non-medicated.

Procedure: Posterolateral lumbar fusion surgery

Surgery group

EXPERIMENTAL

Two MD catheters is placed in the paraspinal muscle at the level of midpoint of incision bilaterally. A reference catheter is placed in the deltoid muscle.

Procedure: Posterolateral lumbar fusion surgery

Interventions

Posterolateral lumbar fusion surgeryPROCEDURE

Two MD catheters with 1% lidocaine 1-2 ml are placed in the paraspinal muscle.

Also known as: Lumbar diseases
Healthy groupSurgery group

Eligibility Criteria

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

You may qualify if:

  • patients who undergo conventional instrumented posterolateral lumbar fusion.

You may not qualify if:

  • previous fusion
  • chronic metabolic disease
  • tumor or metastasis
  • postoperative surgical complications and complications during surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Gang Ren, MD, PhD

    Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2009

First Posted

December 19, 2011

Study Start

January 1, 2007

Primary Completion

December 1, 2007

Study Completion

June 1, 2008

Last Updated

September 15, 2014

Record last verified: 2014-09