Guided Oblique Interbody Lumbar Fusion - Full Text View

Sponsored by:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00786955

Purpose

To collect data regarding the safety and efficacy of the GO-LIF procedure for spinal fixation and stabilization, in conjunction with conventional approaches for interbody lumbar fusion. This is in order to allow for evidence-based comparison to pedicle-screw-based techniques as described in the literature.

Condition	Intervention	Phase
Spinal Fusion	Procedure: trans-pedicular trans-discal screws for stabilization of a single lumbar motion segment, in conjunction with interbody spinal fusion.	Phase I Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

Further study details as provided by Hadassah Medical Organization:

Arms	Assigned Interventions
GO-LIF APPROACH: Experimental	Procedure: trans-pedicular trans-discal screws for stabilization of a single lumbar motion segment, in conjunction with interbody spinal fusion.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients requiring single-level instrumented interbody fusion from L1 to S1, as indicated for mechanical or discogenic or idiopathic back pain or degenerative disc disease or instability.

Or any of criteria below
Patients with Grade I or Grade II spondylolisthesis in the sagittal plane with preserved or normal sagittal alignment requiring single-level instrumented interbody fusion from L1 to S1.
Patients must have normal alignment of the spine in the coronal view.
The interbody fusion approach may TLIF or PLIF or XLIF or ALIF or other, as clinically indicated.
The procedure may be combined with a Micro-decompression and/or micro-discectomy and/or other procedures, as clinically indicated.

Exclusion Criteria:

Lumbar hyper-lordosis - greater than 70° between superior endplate of S1 and superior endplate of L1).
Sacral anomalies if fixation into sacrum is indicated.
Spondylolisthesis grade III or higher.
Global spinal deformity, such as scoliosis with Cobb angle greater than 10°.
Infection or tumor, including focal infections such as discitis or osteomyelitis.
Osteoporotic bone structure - T-score of less than minus-2.5.
Vertebral body fractures in the affected vertebrae or those adjacent to them.
Obesity - Body Mass Index equal to or higher than 30.

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Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Hadassah Medical Organization
Study ID Numbers:	HMO-CTIL-KAP-001
Study First Received:	November 5, 2008
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00786955
Health Authority:	Israel: Ministry of Health

ClinicalTrials.gov processed this record on January 16, 2009