Degenerative Disc DiseaseNCT00678171
A Pilot Study to Evaluate an Osteogenic Protein 1 (OP-1) Putty Spinal System and an Autograft Spinal System
A study testing TLIF with a PEEK Spacer System and XIA Spinal System in people with Degenerative Disc Disease, run by Olympus Biotech Corporation at 10 sites in United States.
Trial summary
This study will explore the use of recombinant OP-1 in conjunction with surgical treatment of single-level TLIF of the lumbar spine. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- TLIF with a PEEK Spacer System and XIA Spinal System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 10 sitesUnited States
- Study dates
- Feb 2007to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Study site
Boston, Massachusetts, 02120
Study site
Charlotte, North Carolina, 28207
Study site
Durango, Colorado, 81301
Study site
Los Angeles, California, 90048
Study site
Minneapolis, Minnesota, 55404
Study site
Omaha, Nebraska, 68154
Study site
Philadelphia, Pennsylvania, 19152
Study site
San Diego, California, 92103
Study site
Southfield, Michigan, 48034
Study site
Temple, Texas, 76508
About this study
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
This study will explore the use of recombinant OP-1 in conjunction with surgical treatment of single-level TLIF of the lumbar spine.
Read the 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).
- Conditions
- Degenerative Disc Disease
- Being tested
- TLIF with a PEEK Spacer System and XIA Spinal System
- Keywords
- Degenerative Disc Disease
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLIF with a PEEK Spacer System and XIA Spinal SystemDevice
Also called TLIF with a Spacer System
TLIF with an AVS™TL PEEK Spacer System and XIA® Spinal System using either OP-1 Putty and/or Autograft.
| Study group | Role | What they receive |
|---|---|---|
| OP-1 Putty | Experimental | 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. Receives: Device: TLIF with a PEEK Spacer System and XIA Spinal System |
| Autograft | Active comparator | Patients randomized to the Autograft Spinal System arm will receive iliac crest autograft with AVS™TL PEEK Spacer System and XIA® Spinal System. Receives: Device: TLIF with a PEEK Spacer System and XIA Spinal System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 and 24 months post intervention
Secondary outcomes (1)
Quality of life determinations (SF-36), pain assessments (VAS), work status and assessment of additional radiographic parameters
Measured: 12 and 24 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startFeb 2007
- Primary completionMar 2008
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olympus Biotech Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678171
- Sponsor's protocol ID
- 06-TLF-001
- Status last verified
- Jan 2014
- First submitted
- 13 May 2008
- Last updated
- 5 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00678171
- Acronym / sponsor ID
- 06-TLF-001
- Conditions
- Degenerative Disc Disease
- Keywords
- Degenerative Disc Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Olympus Biotech CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 15 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will explore the use of recombinant OP-1 in conjunction with surgical treatment of single-level TLIF of the lumbar spine.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OP-1 Putty | Experimental | Device: TLIF with a PEEK Spacer System and XIA Spinal SystemPatients randomized to the OP-1 Putty Spinal System arm will receive OP-1 Putty with AVS™TL PEEK Spacer System and XIA® Spinal System. |
| Autograft | Active comparator | Device: TLIF with a PEEK Spacer System and XIA Spinal SystemPatients randomized to the Autograft Spinal System arm will receive iliac crest autograft with AVS™TL PEEK Spacer System and XIA® Spinal System. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TLIF with a PEEK Spacer System and XIA Spinal SystemAlso: TLIF with a Spacer SystemTLIF with an AVS™TL PEEK Spacer System and XIA® Spinal System using either OP-1 Putty and/or Autograft. | Device | Autograft, OP-1 Putty |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TLIF with a PEEK Spacer System and XIA Spinal System in people with Degenerative Disc Disease, run by Olympus Biotech Corporation at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2014.