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Completed

NCT Number: NCT01513577

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

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.

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Key information

Conditions

Degenerative Disc Disease Bone Diseases Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pedicle screws

Other

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.

Percutaneous stab incisions

Other

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.

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Northern Orthopaedic Division, Denmark

Other

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2004
Study completion
2006
First posted
Jan 20, 2012
Registry last updated
Sep 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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