Status:
COMPLETED
Prospective, Multi-Center Clinical Outcomes Study Evaluating the chronOS Strip Combined With Bone Marrow Aspirate
Lead Sponsor:
Synthes USA HQ, Inc.
Conditions:
Degeneration of Lumbar Intervertebral Disc
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The chronOS Strip is a synthetic bone void filler manufactured from chronOS beta-tricalcium phosphate (β-TCP) granules and a resorbable polymer \[poly(lactide co-ε-caprolactone)\]. The chronOS Strip, ...
Eligibility Criteria
Inclusion
- Has the following indication for posterolateral fusion (transverse process and facet fusion) with posterior rod and screw fixation:
- • Degenerative Disc Disease (DDD), with or without stenosis. Diagnosis of DDD requires back and/or leg (radicular) pain along with:
- Instability (≥ 3 mm translation or ≥ 5° angulation); or
- MRI confirmation of Modic Type 1 or Type 2 changes; or
- High intensity zones in the disc space.
- Has one or two motion segment(s) to be fused between L2 and S1;
- Skeletally mature adult, at least 18 years of age at the time of surgery;
- Oswestry Low Back Pain Disability Questionnaire score ≥ 30 (out of 100);
- Has completed at least 6 months of conservative therapy, which may include physical therapy, bracing, systemic or injected medications;
- Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures;
- Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the study.
Exclusion
- Three or more motion segments to be fused;
- Degenerative scoliosis, defined as Cobb angle \> 10° at any level in lumbar spine;
- Has had a previous interbody fusion or posterolateral fusion attempt at any level of the lumbar spine;
- Active systemic or local infection;
- Known or documented history of communicable disease, including AIDS and HIV;
- Active Hepatitis (receiving medical treatment within two years);
- Active rheumatoid arthritis, non-controlled diabetes mellitus, or any other medical condition(s) that would represent a significant increase in surgical risk or interfere with normal healing;
- Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for \> 1 month within last 12 months;
- Known history of Paget's disease, osteomalacia, or any other metabolic bone disease;
- Osteopenia or Osteoporosis: A screening questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients who require a dual energy x-ray absorptiometry (DXA) bone mineral density measurement. If DXA is required, exclusion will be defined as a DXA bone density measured T score less than or equal to -1.0.
- Morbid obesity defined as a body mass index \> 40 kg/m2 or weight more than 100 pounds over ideal body weight;
- Active malignancy. A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and there has been no clinical signs or symptoms of the malignancy for more than 5 years;
- Current or recent history (within last 2 years) of substance abuse (e.g., recreational drugs, narcotics, or alcohol);
- Pregnant or planning to become pregnant during study period;
- Involved in study of another investigational product that may affect outcome;
- History of psychosocial disorders that could prevent accurate completion of self reporting assessment scales;
- Patients who are incarcerated.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT00943384
Start Date
July 1 2009
End Date
October 1 2013
Last Update
November 26 2014
Active Locations (13)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Hartford Hospital
Hartford, Connecticut, United States, 06102
3
Bay Area Neurosurgery
Brandon, Florida, United States, 33511
4
Atlanta Neurosurgical Associates
Decatur, Georgia, United States, 30033