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

NCT01513577 | Completed

• 1 other identifier: ON-07-009-RAS
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Degenerative Disc Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percutaneous technique versus conventional open technique.

  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.

  Two years

Secondary Outcomes (1)

• Improvements of recovery and convalescence.

  Two years

Study Arms (2)

Minimal invasive pedicular screw

EXPERIMENTAL

Other: Pedicle screws

Standard open insertion

EXPERIMENTAL

Other: Percutaneous stab incisions

Interventions

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.

Minimal invasive pedicular screw

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.

Standard open insertion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Northern Orthopaedic Division, Denmark: lead

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Interventions

Pedicle Screws

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Bone Screws; Internal Fixators; Prostheses and Implants; Equipment and Supplies; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Surgical Fixation Devices

Study Officials

• Sten Rasmussen, M.D.

  Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

• Henrik Kehlet, M.D.

  Department of Orthopaedic Surgery, Vejle and Give Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2011
• First Posted: January 20, 2012
• Study Start: January 1, 2003
• Primary Completion: December 1, 2004
• Study Completion: June 1, 2006
• Last Updated: September 15, 2014

Record last verified: 2014-09