A Pilot Study to Evaluate an Osteogenic Protein 1 (OP-1) Putty Spinal System and an Autograft Spinal System
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ClinicalTrials.gov Identifier: NCT00678171 |
Recruitment Status
:
Completed
First Posted
: May 15, 2008
Last Update Posted
: February 5, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Degenerative Disc Disease | Device: TLIF with a PEEK Spacer System and XIA Spinal System | Not Applicable |
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 |

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.
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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
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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
|
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
- 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].
- The patient requires single level lumbar fusion (L2 to S1)
Exclusion Criteria:
- 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}.
- The patient has Grade II, Grade III or Grade IV spondylolisthesis.
- 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.
- 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.
- The patient has been treated in the last 6 months with radiation, chemotherapy, immunosuppression or systemic corticosteroids.
- 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.
- The patient is morbidly obese (defined as body mass index [BMI] > 35).
- The patient currently uses tobacco products, within 3 weeks prior to time of treatment.
- 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.
- The patient has previously been treated with or exposed to any Bone Morphogenetic Proteins (BMPs).
- 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.
- The patient has a previous diagnosis of Paget's disease, osteomalacia or any other endocrine or metabolic bone disease that affects osteogenesis.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00678171
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 |
Responsible Party: | Olympus Biotech Corporation |
ClinicalTrials.gov Identifier: | NCT00678171 History of Changes |
Other Study ID Numbers: |
06-TLF-001 |
First Posted: | May 15, 2008 Key Record Dates |
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 |