Evaluation of Aspen Spinous Process Fixation System and PLIF Technique for the Treatment of Low Back Pain

Low Back Pain Clinical Trial

Official title:

Evaluation of Aspen Spinous Process Fixation System and PLIF Technique for the Treatment of Low Back Pain in the Presence of Lumbar Instability and Degenerative Disk Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01918943
• Other study ID #: ABC-Aspen-2013
• Status: Recruiting
• Phase: N/A
• First received: August 6, 2013
• Last updated: August 6, 2013
• Start date: August 2012
• Est. completion date: August 2015

Study information

• Verified date: August 2013
• Source: American British Cowdray Medical Center
• Contact: Eduardo Galvan, MD
• Phone: 52(55)16647205
• Email: egalh[@]yahoo.com
• Is FDA regulated: No
• Health authority: Mexico: American British Cowdray Hospital Review Board
• Study type: Observational

Clinical Trial Summary

Lumbar spinal fusion was introduced approximately 70 years ago and has evolved as a treatment option for symptomatic spinal instability, spinal stenosis, spondylolisthesis, and degenerative scoliosis.

Many techniques evolved since then, from wiring, rods, pedicle screws, and recently inter-spinous fixation devices like the Aspen. Along its evolutionary trail, various methods for achieving circumferential fusion have arisen. Distinct from staged anterior/posterior fusion techniques, two methods of achieving an interbody fusion from a posterior approach have emerged: posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF). Recently, the lateral approach for interbody fusion (XLIF) has became a more common technique, requiring in some cases, complemental posterior fixation with pedicle screws, facet screws or interspinous fixation devices like the Aspen device.

In this study, we address the clinical and radiological outcome of a novel technique using standard PLIF interbody fusion and insertion of the Aspen device via posterior lumbar approach.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Oswestry Disability Index score >30%

• Diagnosis of low back pain and/or radicular pain associated to spinal instability

• Diagnosis of low back pain and/or radicular pain associated to degenerative disc disease

• Elective single level surgery

• Signed informed consent form

Exclusion Criteria:

• Previous surgery with complete laminectomy, pars defect, etc

• Patients that during the surgery requires complete laminectomy at level of the surgery

• Structural lesion to facet joints

• Osteoporosis

• Systemic or local infection

• Pregnant or planning to become pregnant

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Spinal Instability
• Spinal Stenosis
• Spondylolisthesis
• Spondylosis

Intervention

Device:
• PLIF and Aspen (spinous process fixation device)
Circunferential fusion with PLIF and postero-lateral fusion with the Aspen device

Locations

Country	Name	City	State
Mexico	American British Cowdray Medical Center	Mexico City	Mexico DF

Sponsors (1)

Lead Sponsor	Collaborator
American British Cowdray Medical Center

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Operative parameters	Surgery time, blood loss	At surgery	No
Primary	Oswestry Disability Index Score Change	Change between Oswestry Disability Index between pre-operative and final 12 months socores	12 months	No
Secondary	Rolland Morris Score	Change in score in the Rolland Morris Score (RMS)	12 months	No
Secondary	Visual Analogue Scale	Change in pain measured by the visual analogue scale	12 months	No
Secondary	Bone fusion (arthrodesis)	Adequate bone fusion measured by computed tomography (CT) scan	12 months	No