Percutaneous Minimal Invasive Pedicular Screw and Rod Insertion in Circumferential Lumbar Fusion

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Northern Orthopaedic Division, Denmark

ClinicalTrials.gov Identifier:

NCT01513577

First received: December 14, 2011

Last updated: May 1, 2013

Last verified: May 2013

History of Changes

Purpose

Convalescence after lumbar surgery is dependent on the extensiveness of the surgical procedure. Minimal invasive techniques in lumbar spine surgery are reported to achieve excellent clinical results with less pain, morbidity and disability.

Condition	Intervention
Degenerative Disc Disease	Other: Pedicle screws Other: Percutaneous stab incisions

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	Percutaneous Minimal Invasive Pedicular Screw and Rod Insertion Reduces Hospital Stay and Morbidity Compared to Open Midline Approach in Circumferential Lumbar Fusion. A Randomized Study With 2 Years Follow-up

Further study details as provided by Northern Orthopaedic Division, Denmark:

Primary Outcome Measures:

Percutaneous technique versus conventional open technique. [ Time Frame: Two years ] [ Designated as safety issue: No ]
The investigators want to assess the effects of percutaneous posterior technique versus conventional open posterior technique on post-fusion pain, mobilization, convalescence, disability and bony fusion in 360 degree lumbar fusion.

Secondary Outcome Measures:

Improvements of recovery and convalescence. [ Time Frame: Two years ] [ Designated as safety issue: No ]
To investigate operative time, blood loss, use of analgesic, days until ambulation without aids, hospitalization, Oswestry Disability Index.

Enrollment:	16
Study Start Date:	January 2003
Study Completion Date:	June 2006
Primary Completion Date:	December 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Minimal invasive pedicular screw	Other: Pedicle screws The control group received posterior fixation with pedicle screws through a midline approach. Through the approach bone was harvested from the right posterior iliac crest. Before closure of the posterior approach an epidural catheter and a drain was placed.
Experimental: Standard open insertion	Other: Percutaneous stab incisions The intervention group received posterior fixation through 6 percutaneous stab incisions with the use of the sextant system. Through a separate 3-4 cm long incision, bone was harvested from the right posterior iliac crest. After decorticating the transverse processes through the stab wounds, the bone graft was placed with a 10 ml cut syringe. An epidural catheter was placed at the end of the posterior procedure.

Arms

Assigned Interventions

Experimental: Minimal invasive pedicular screw

Other: Pedicle screws

The control group received posterior fixation with pedicle screws through a midline approach. Through the approach bone was harvested from the right posterior iliac crest. Before closure of the posterior approach an epidural catheter and a drain was placed.

Experimental: Standard open insertion

Other: Percutaneous stab incisions

The intervention group received posterior fixation through 6 percutaneous stab incisions with the use of the sextant system. Through a separate 3-4 cm long incision, bone was harvested from the right posterior iliac crest. After decorticating the transverse processes through the stab wounds, the bone graft was placed with a 10 ml cut syringe. An epidural catheter was placed at the end of the posterior procedure.

Detailed Description:

To achieve lumbar fusion when there is no need for decompression of the neural structures a posterior midline approach and a left anterior retroperitoneal approach is used. The retroperitoneal anterior approach to the lumbar spine offers some benefits compared with the posterior approach. Dural injury and epidural scarring can be avoided, and an interbody fusion graft can be placed with minimal risk to the nerve roots. However, the extensive posterior midline approach with extensive muscle dissection is necessary to place the pedicular screws.

A report of a follow-up period of 2 years of a randomized trial of minimal invasive insertion of pedicular screws and rods in lumbar fusion.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Degenerative disc disease in one of the three lower lumbar levels.

Exclusion criteria:

Previous fusion, metabolic bone disease, co-morbidity or psychological instability.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01513577

Sponsors and Collaborators

Northern Orthopaedic Division, Denmark

Investigators

Principal Investigator:	Sten Rasmussen, M.D.	Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
Study Chair:	Henrik Kehlet, M.D.	Department of Orthopaedic Surgery, Vejle and Give Hospital

More Information

No publications provided

Responsible Party:	Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:	NCT01513577 History of Changes
Other Study ID Numbers:	ON-07-009-RAS
Study First Received:	December 14, 2011
Last Updated:	May 1, 2013
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics Denmark: Danish Dataprotection Agency

Keywords provided by Northern Orthopaedic Division, Denmark:

Lumbar fusion
Pedicular screws
Minimal invasive technique
Randomized controlled trial

Additional relevant MeSH terms:

Intervertebral Disk Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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