- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00948532
Osteocel® Plus in eXtreme Lateral Interbody Fusion (XLIF®)
Osteocel® Plus in eXtreme Lateral Interbody Fusion (XLIF®): Evaluation of Radiographic and Patient Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Osteocel Plus is an allograft cellular bone matrix containing native mesenchymal stem cells (MSCs) which is intended to mimic the biologic performance of autograft without the morbidity associated with the autograft harvest. Mesenchymal stem cells, like those found in Osteocel Plus, are naturally occurring in the body and can differentiate into a variety of tissue types, depending on the local environment. Once implanted, MSCs can differentiate into osteoblasts, which produce new bone matrix. MSCs also naturally secrete bone-inducing growth factors that signal the patient's endogenous cells to migrate and participate in the bone formation process. Osteocel Plus is different from other orthobiologic products such as DBM and allograft cancellous bone because it contains living stem cells, which provide osteogenic potential. The cells include mesenchymal stem cells from an adult human donor; they are not from an embryonic source.
This study is being conducted to determine the percentage of patients with solid spinal fusions after being treated with Osteocel in an XLIF procedure. Due to the unique processing conditions, Osteocel Plus retains a high concentration of stem cells in conjunction with the allograft bone matrix, so it is hypothesized that the fusion rate with Osteocel Plus will be comparable to published data for autograft. The Osteocel product family has already been used in approximately 15,000 cases worldwide.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
-
La Jolla, California, United States, 92037
- Shiley Center for Orthopaedic, Scripps Green Hospital
-
-
Florida
-
Hollywood, Florida, United States, 33021
- Broward Spine Institute
-
Miami Beach, Florida, United States, 33140
- South Florida Spine Institute, Mount Sinai Medical Center
-
Sarasota, Florida, United States, 34232
- Southeastern Spine Center, Doctors Hospital of Sarasota
-
Tampa, Florida, United States, 33606
- USF, Tampa General Hospital
-
-
Georgia
-
Marietta, Georgia, United States, 30060
- Pinnacle Orthopaedics, Wellstone Kennestone Hospital
-
-
Illinois
-
Naperville, Illinois, United States, 60540
- The Spine Center of DuPage Medical Group, Edward Hospital
-
-
Indiana
-
Indianapolis, Indiana, United States, 46219
- Indiana Center for Neurosurgery
-
-
Missouri
-
Columbia, Missouri, United States, 65205
- Columbia Orthopaedic Group, Boone Hospital Center
-
Jefferson City, Missouri, United States, 65101
- Spine Midwest, St. Mary's Health Center
-
-
Nevada
-
Las Vegas, Nevada, United States, 89109
- Western Regional Center for Brain & Spine Surgery, Surgery Center of S. Nevada
-
-
New York
-
Lockport, New York, United States, 14094
- Buffalo Spine Surgery, Kenmore Mercy
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27710
- Duke University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Persistent back and/or leg pain unresponsive to conservative treatment for at least six (6) months, unless clinically indicated earlier
- Indicated for interbody fusion of one or two contiguous lumbar segments (L1 to L5)
- Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies
- 18-80 years of age at the date of written informed consent
- Able to undergo surgery based on physical exam, medical history and surgeon judgment
- Expected to survive at least 2 years beyond surgery
- Willing and able to return for post-treatment exams according to the follow-up called for in the protocol
- Signed and dated Informed Consent Form
Exclusion Criteria:
- Patient has a mental or physical condition that would limit the ability to comply with study requirements
- Lumbar spine abnormality requiring treatment at more than two levels
- Systemic or local infection; active or latent
- Previous failed fusion at the operative level
- Diseases that significantly inhibit bone healing (osteoporosis, metabolic bone disease, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease)
- Undergoing chemotherapy or radiation treatment, or chronic use of steroids (defined as more than 6 weeks of steroid use within 12 months of surgery, other than episodic use or inhaled corticosteroids)
- Pregnant, or plans to become pregnant during the study
- Subject is a prisoner
- Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contended)
- A significant general illness (e.g., HIV, active metastatic cancer of any type) is present; subject is immunocompromised or is being treated with immunosuppressive agents
- Participating in another clinical study that would confound study data
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The proportion of subjects with radiographically apparent fusion.
Time Frame: 6-months, 12-months and 24-months
|
6-months, 12-months and 24-months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The evaluation of angular displacement on flexion/extension films.
Time Frame: Post-op, 6-week, 3-month, 6-month, 12-month, 24-month
|
Post-op, 6-week, 3-month, 6-month, 12-month, 24-month
|
The evaluation of bridging bone on CT.
Time Frame: 6-month, 12-month
|
6-month, 12-month
|
Preservation of interbody height over time.
Time Frame: All post-operative follow-up visits: Post-op, 6-week, 3-month, 6-month, 12-month, 24-month
|
All post-operative follow-up visits: Post-op, 6-week, 3-month, 6-month, 12-month, 24-month
|
The rate of complications attributable to the use of Osteocel Plus requiring intervention.
Time Frame: All study follow-up visits: Post-op, 6-week, 3-month, 6-month, 12-month, 24-month
|
All study follow-up visits: Post-op, 6-week, 3-month, 6-month, 12-month, 24-month
|
The change in subject self-reported pain ratings (VAS scores).
Time Frame: from baseline through post-operation follow-up (visits at post-op, 6-week, 3-month, 6-month, 12-month and 24-months)
|
from baseline through post-operation follow-up (visits at post-op, 6-week, 3-month, 6-month, 12-month and 24-months)
|
The change in Oswestry Disability Index scores.
Time Frame: from baseline through post-operation follow-up (visits at post-op, 6-week, 3-month, 6-month, 12-month and 24-months)
|
from baseline through post-operation follow-up (visits at post-op, 6-week, 3-month, 6-month, 12-month and 24-months)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Kelli Howell, MS, NuVasive
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NUVA.OC.0801
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Back Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
Federal University of Minas GeraisRecruitingBack Pain | Low Back Pain | Chronic Low-back Pain | Back Pain Lower Back ChronicBrazil
-
Balgrist University HospitalUniversity of Zurich, Epidemiology, Biostatistics and Prevention InstituteCompletedBack Pain | Back Pain With Radiation | Back Pain, LowSwitzerland
-
Vanderbilt University Medical CenterWithdrawnBack Pain, Low | Back Pain Without RadiationUnited States
-
Columbia UniversityUpright Technologies Ltd.CompletedLower Back Pain | Back Pain | Postural Low Back PainUnited States
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
University of Colorado, BoulderNational Institutes of Health (NIH); Radiological Society of North America; Psychophysiologic... and other collaboratorsCompletedChronic Pain | Back Pain Lower Back Chronic | Back Pain, LowUnited States
-
Canandaigua VA Medical CenterFoot Levelers, Inc.; Northeast College of Health SciencesTerminatedBack Pain Lower Back ChronicUnited States
-
Marco LoggiaNational Institute of Neurological Disorders and Stroke (NINDS)Active, not recruitingLow Back Pain | Pain, Chronic | Back Pain Lower Back Chronic | Back Pain With Radiation | Back Pain Without Radiation | Back AcheUnited States
Clinical Trials on biologic, Osteocel Plus
-
NuVasiveCompletedDegenerative Disc Disease in Cervical SpineUnited States
-
NuVasiveCompletedDegenerative Disc Disease, LumbarUnited States
-
NuVasiveCompletedDegenerative Disc DiseaseUnited States
-
NuVasiveCompleted
-
University of CalgaryMedtronicRecruiting
-
DermTechRecruitingAtopic DermatitisUnited States
-
University of Missouri-ColumbiaCompletedKnee Osteoarthritis | Post-traumatic OsteoarthritisUnited States
-
Miromatrix Medical Inc.Completed
-
Assistance Publique - Hôpitaux de ParisNot yet recruiting
-
Psoriasis Treatment Center of Central New JerseyJanssen Scientific Affairs, LLCCompleted