A Study of the In-Space Device for Treatment of Moderate Spinal Stenosis - Full Text View

Sponsored by:	Synthes Spine
Information provided by:	Synthes Spine
ClinicalTrials.gov Identifier:	NCT00697827

Purpose

The purpose of this study is to evaluate the safety and effectiveness of the In-Space compared to the X STOP Interspinous Process Distraction (IPD) device ("X STOP") for the treatment of patients experiencing intermittent neurogenic claudication secondary to moderate degenerative lumbar stenosis at one or two lumbar levels.

Condition	Intervention	Phase
Spinal Stenosis	Device: Interspinous Spacer device Device: Interspinous Process Distraction Device	Phase III

MedlinePlus related topics: Spinal Stenosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center Randomized Controlled Trial of the In-Space Compared to X STOP® for Treatment of Moderate Degenerative Lumbar Spinal Stenosis

Further study details as provided by Synthes Spine:

Primary Outcome Measures:

Zurich Claudication Questionnaire [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Oswestry Disability Index (ODI), [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental In-Space	Device: Interspinous Spacer device Device: In-Space
2: Active Comparator X STOP	Device: Interspinous Process Distraction Device Device: X STOP

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

≥ 50 years in age
Leg/buttock/groin pain, with or without back pain, that can be completely relieved by flexion such as when sitting in a chair.
Zurich Claudication Questionnaire Score ≥ 2.0,
Neurogenic intermittent claudication secondary to moderate lumbar spinal stenosis
Has completed at least 6 months conservative therapy

Exclusion Criteria:

Axial back pain only without leg/buttock/groin pain
Has had any prior lumbar spine surgery at any level
Significant scoliosis, defined as Cobb angle > 10°
Spondylolisthesis > Grade 1 or isthmic spondylolisthesis at affected level
Osteoporosis
Morbid obesity, defined as BMI > 40 kg/m2

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697827

Contacts

Contact: Abigail Coleman	610-719-5735	coleman.abigail@synthes.com
Contact: Amy Doherty	610-719-5697	doherty.amy@synthes.com

Locations

United States, Minnesota
Institute for Low Back and Neck Care	Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Sandy Miller 952-814-6640 sandy.miller@ilbnc.com
Principal Investigator: Richard Salib, M.D.
United States, North Carolina
OrthoCarolina Spine Center	Recruiting
Charlotte, North Carolina, United States, 28209
Contact: Hillary Pace 704-323-2261
Contact: Caryn Thompson (704) 323-2268
Principal Investigator: Bruce Darden, M.D.
United States, Tennessee
Neurosurgical Associates at Centennial Medical Center	Recruiting
Nashville, Tennessee, United States, 37203
Contact: Kimberly Dudukovich 615-986-1256
Principal Investigator: Michael Schlosser, M.D.
United States, Virginia
Neurosurgical Specialists, Inc.	Recruiting
Norfolk, Virginia, United States, 23510
Contact: Lee Anne Lamkin 757-625-4455 lalamkin@att.net
Principal Investigator: Grant Skidmore, M.D.
United States, Washington
Madigan Army Medical Center	Recruiting
Tacoma, Washington, United States, 98341
Contact: Erinn Morris 253-968-6590 Erinn.Morris@us.army.mil
Principal Investigator: John Devine, MD, LTC

Sponsors and Collaborators

Synthes Spine

More Information

Responsible Party:	Synthes ( John Walsh, Vice President Regulatory and Clinical Affairs )
Study ID Numbers:	INSP01
Study First Received:	June 11, 2008
Last Updated:	October 21, 2008
ClinicalTrials.gov Identifier:	NCT00697827
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Spinal Diseases
Pathological Conditions, Anatomical
Musculoskeletal Diseases

Constriction, Pathologic
Bone Diseases
Spinal Stenosis

ClinicalTrials.gov processed this record on January 15, 2009