Spineology Clinical Outcomes Trial: An IDE Investigation



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:21 - 80
Updated:12/1/2016
Start Date:February 2015
End Date:February 2019
Contact:Rose Griffith
Email:Rgriffith@spineology.com
Phone:651-256-8503

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Spineology Clinical Outcomes Trial: An Investigation Device Exempt (IDE) Performance Goal Clinical Investigation

This study evaluates the safety and effectiveness of the Spineology Interbody Fusion System
(SIFS) in an instrumented interbody lumbar fusion in subjects presenting with symptomatic
single-level lumbar degenerative disc disease.

This regulated prospective, multi-center, Institutional Review Board (IRB) approved
single-arm performance goal clinical investigation will be conducted at a maximum of 15
centers with no more than 102 subjects being enrolled and treated.

It is anticipated that enrollment will be compete within 24 months. Subjects will be
actively evaluated to 24-months postoperative and depending on enrollment duration, may be
remotely assessed through self-administered surveys at 36- and 48-months.

The primary endpoint, assessed at 24-months postoperative, is a composite score that
includes pain, function, fusion and safety assessments.

Inclusion Criteria:

- Skeletally mature;

- Confirmed symptomatic single-level lumbar degenerative disc disease (DDD) between L2
and S1;

- Minimum low back VAS pain score of 40mm;

- Minimum ODI score of 40;

- Received at least 6-months of conservative care; and

- Willing and able to comply with protocol evaluations and provide informed consent.

Exclusion Criteria:

- Previous fusion or total disc replacement at the index level;

- Greater than Grade I spondylolisthesis;

- Has symptomatic multi-level lumbar DDD;

- Active systemic infection or infection at the local surgical site;

- Active or suspected malignancy;

- Body Mass Index of greater than or equal to 40;

- Significant metabolic bone disease;

- Taking medication known to interfere with bone healing;

- Has a current substance abuse disorder;

- Has a somatoform, dissociative, eating or psychotic disorder;

- Waddell Signs of inorganic behavior;

- Current tobacco user;

- Is a prisoner;

- If female, pregnant or contemplating pregnancy during follow-up period; or

- Enrolled in a concurrent clinical investigation that may confound the findings of the
current investigation
We found this trial at
10
sites
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: John Chi, M.D., MPH
Phone: 617-732-8527
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Principal Investigator: John Pollina, M.D.
Phone: 716-888-4811
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Principal Investigator: Faheem Sandhu, M.D., PhD
Phone: 202-444-1210
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Principal Investigator: Stephane Lavoie, M.D.
Phone: 386-734-9122
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Principal Investigator: Richard Ozuna, M.D.
Phone: 978-818-6459
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Principal Investigator: Mohamad Bydon, M.D.
Phone: 507-293-1963
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Principal Investigator: Pierce Nunley, M.D.
Phone: 318-629-5585
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Principal Investigator: Martin Krag, M.D.
Phone: 802-656-9912
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Principal Investigator: Deepak Awasthi, M.D.
Phone: 985-493-4510
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