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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01513577

Enrollment

Registered

2012-01-20

Start date

2003-01-31

Completion date

2006-06-30

Last updated

2014-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Disc Disease

Keywords

Lumbar fusion, Pedicular screws, Minimal invasive technique, Randomized controlled trial

Brief summary

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.

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.

Interventions

OTHERPedicle 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.

OTHERPercutaneous 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Percutaneous technique versus conventional open technique.	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

Measure	Time frame	Description
Improvements of recovery and convalescence.	Two years	To investigate operative time, blood loss, use of analgesic, days until ambulation without aids, hospitalization, Oswestry Disability Index.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026