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

NCT01513577 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2014-09-15

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Northern Orthopaedic Division, Denmark

    lead OTHER

Principal Investigators

  • Sten Rasmussen, M.D. · Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark

  • Henrik Kehlet, M.D. · Department of Orthopaedic Surgery, Vejle and Give Hospital

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2004-12-31
Completion
2006-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01513577 on ClinicalTrials.gov