Prospective, Multi-Center Clinical Outcomes Study Evaluating the chronOS Strip Combined With Bone Marrow Aspirate

Completed · Not applicable

Conditions studied: Degeneration of Lumbar Intervertebral Disc

In brief

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, combined with autogenous bone and/or bone marrow or autograft, is intended to be used in the spine for posterolateral fusion. The purpose of this prospective, multi-center clinical case series was to evaluate posterolateral fusion rates in a prospective series of patients with degenerative disc disease. The surgical procedure consisted of instrumented posterolateral fusion with interbody support. The chronOS Strip, combined with bone marrow aspirate and local bone, was applied to the posterolateral gutters.

Key facts

Study ID

NCT00943384

Run by

Synthes USA HQ, Inc.

People needed

104

Starts

2009-07-01

Expected to finish

2013-10-01

Last updated by the study team

2014-11-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Bay Area Neurosurgery — Brandon, Florida, United States
• Atlanta Neurosurgical Associates — Decatur, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• The Boston Spine Group — Newton, Massachusetts, United States
• Southern New York Neurosurgical Group — Johnson City, New York, United States
• The Rothman Institute — Philadelphia, Pennsylvania, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• UPMC Presbyterian Dept. of Neurosurgery — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center Department of Neurosurgery/Spine Research — Nashville, Tennessee, United States
• Orthopaedic and Spine Center — Newport News, Virginia, United States

Full record on ClinicalTrials.gov

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