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

Not Applicable

Completed

• Conditions: Degenerative Disc Disease
• Interventions: Other: Pedicle screws; Other: Percutaneous stab incisions

• Registration Number: NCT01513577
• Lead Sponsor: Northern Orthopaedic Division, Denmark

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.

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2004-12
• Study Completion: 2006-06
• Study First Submitted: 2011-12-14
• Study First Submitted QC: 2012-01-19
• Study First Posted: 2012-01-20
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-12
• Last Update Posted: 2014-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Minimal invasive pedicular screw	Pedicle screws	-
Standard open insertion	Percutaneous stab incisions	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.