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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01513577
First Posted: January 20, 2012
Last Update Posted: September 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
  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
Intervention Model: Parallel Assignment
Masking: None (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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percutaneous technique versus conventional open technique. [ Time Frame: Two years ]
    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 ]
    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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT01513577     History of Changes
Other Study ID Numbers: ON-07-009-RAS
First Submitted: December 14, 2011
First Posted: January 20, 2012
Last Update Posted: September 15, 2014
Last Verified: September 2014

Keywords provided by Northern Orthopaedic Division, Denmark:
Lumbar fusion
Pedicular screws
Minimal invasive technique
Randomized controlled trial

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases