A Pilot Study to Evaluate an Osteogenic Protein 1 (OP-1) Putty Spinal System and an Autograft Spinal System

Study Description

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Brief Summary:

This study will explore the use of recombinant OP-1 in conjunction with surgical treatment of single-level TLIF of the lumbar spine.

Condition or disease	Intervention/treatment	Phase
Degenerative Disc Disease	Device: TLIF with a PEEK Spacer System and XIA Spinal System	Not Applicable

Detailed Description:

This pilot study is a randomized, multi-center, prospective, controlled study of the efficacy and safety of OP-1 Putty Spinal System in patients requiring a single level transforaminal interbody fusion of the lumbar spine (TLIF).

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	30 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Pilot Study to Evaluate an OP-1 Putty Spinal System and an Autograft Spinal System in Patients Requiring Transforaminal Lumbar Interbody Fusion of the Spine
Study Start Date :	February 2007
Actual Primary Completion Date :	March 2008
Actual Study Completion Date :	March 2010

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: OP-1 Putty; Patients randomized to the OP-1 Putty Spinal System arm will receive OP-1 Putty with AVS™TL PEEK Spacer System and XIA® Spinal System.	Device: TLIF with a PEEK Spacer System and XIA Spinal System; TLIF with an AVS™TL PEEK Spacer System and XIA® Spinal System using either OP-1 Putty and/or Autograft.; Other Name: TLIF with a Spacer System
Active Comparator: Autograft; Patients randomized to the Autograft Spinal System arm will receive iliac crest autograft with AVS™TL PEEK Spacer System and XIA® Spinal System.	Device: TLIF with a PEEK Spacer System and XIA Spinal System; TLIF with an AVS™TL PEEK Spacer System and XIA® Spinal System using either OP-1 Putty and/or Autograft.; Other Name: TLIF with a Spacer System

Outcome Measures

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Primary Outcome Measures :

1. Pain and function as measured by an Oswestry Disability Index, no revisions, removals or supplemental fixations, fusion success, defined as radiographic evidence of fusion, maintenance or improvement in lower extremity neurologic function [ Time Frame: 12 and 24 months post intervention ]

Secondary Outcome Measures :

1. Quality of life determinations (SF-36), pain assessments (VAS), work status and assessment of additional radiographic parameters [ Time Frame: 12 and 24 months post intervention ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. The patient is willing and able to understand, sign and date the study-specific, Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved patient informed consent and applicable privacy regulations.
2. The patient has a documented diagnosis of DDD with up to Grade I spondylolisthesis demonstrated by radiographic imaging (by plain film/discography within 12 weeks of surgery and/or computed tomography (CT scan/magnetic resonance imaging [MRI].
3. The patient requires single level lumbar fusion (L2 to S1)

Exclusion Criteria:

1. The patient has a history of previous surgery in the lumbar spine with or without attempted fusion {Note: a history of lumbar decompression surgery is permitted}.
2. The patient has Grade II, Grade III or Grade IV spondylolisthesis.
3. The patient has gross spinal instability measured on flexion/extension radiographs of >25% translation of the vertebrae, or ≥20 degrees of angular motion or has significant (>10%) scoliosis.
4. The patient is receiving treatment (before, during or after surgery) with a drug that interferes with bone metabolism or is being treated with a bone growth stimulator.
5. The patient has been treated in the last 6 months with radiation, chemotherapy, immunosuppression or systemic corticosteroids.
6. The patient has a history of, or has any malignancy or spinal tumor of any type, with the exception of a history of a treated basal or squamous cell carcinoma.
7. The patient is morbidly obese (defined as body mass index [BMI] > 35).
8. The patient currently uses tobacco products, within 3 weeks prior to time of treatment.
9. The patient is known to require at the time of treatment, additional surgery to the lumbar spinal region within the next 6 months or has symptomatic multilevel degenerative disease requiring possible instrumented fusion of more than one level.
10. The patient has previously been treated with or exposed to any Bone Morphogenetic Proteins (BMPs).
11. The patient is contraindicated for iliac crest autografting in that the Investigator believes the patient would be unable to provide sufficient quantity or adequate quality autograft (e.g., osteoporosis as defined by this protocol) from a unilateral iliac crest harvest.
12. The patient has a previous diagnosis of Paget's disease, osteomalacia or any other endocrine or metabolic bone disease that affects osteogenesis.
13. The patient has a documented history of osteoporosis or has a risk of osteoporosis as defined by an Osteoporosis Risk Assessment Instrument (ORAI) score of ≥ 9 and a DEXA Scan T score of ≥-2.5 standard deviations below the normal range within one year of enrollment.

Contacts and Locations

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Locations

United States, California
Los Angeles, California, United States, 90048
San Diego, California, United States, 92103
United States, Colorado
Durango, Colorado, United States, 81301
United States, Massachusetts
Boston, Massachusetts, United States, 02120
United States, Michigan
Southfield, Michigan, United States, 48034
United States, Minnesota
Minneapolis, Minnesota, United States, 55404
United States, Nebraska
Omaha, Nebraska, United States, 68154
United States, North Carolina
Charlotte, North Carolina, United States, 28207
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19152
United States, Texas
Temple, Texas, United States, 76508

Sponsors and Collaborators

Olympus Biotech Corporation

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Olympus Biotech Corporation
ClinicalTrials.gov Identifier:	NCT00678171 History of Changes
Other Study ID Numbers:	06-TLF-001
First Posted:	May 15, 2008
Last Update Posted:	February 5, 2014
Last Verified:	January 2014

Keywords provided by Olympus Biotech Corporation:

Degenerative Disc Disease

Additional relevant MeSH terms:

Intervertebral Disc Degeneration; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases