Clinical trial NCT00943384: Prospective, Multi-Center Clinical Outcomes Study Evaluating the chronOS Strip Combined With Bone Marrow Aspirate
Official title: Prospective, Multi-Center Clinical Outcomes Study Evaluating the chronOS Strip Combined With Bone Marrow Aspirate Plus Local Bone for Posterolateral Lumbar Interbody Fusion or Lumbosacral Interbody Fusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degeneration of Lumbar Intervertebral Disc
Lead sponsor: Synthes USA HQ, Inc.
Sponsor class: INDUSTRY
First posted: 2009-07-22
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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, 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.


Eligibility criteria: Inclusion Criteria:

1. 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:
   1. Instability (≥ 3 mm translation or ≥ 5° angulation); or
   2. MRI confirmation of Modic Type 1 or Type 2 changes; or
   3. High intensity zones in the disc space.
2. Has one or two motion segment(s) to be fused between L2 and S1;
3. Skeletally mature adult, at least 18 years of age at the time of surgery;
4. Oswestry Low Back Pain Disability Questionnaire score ≥ 30 (out of 100);
5. Has completed at least 6 months of conservative therapy, which may include physical therapy, bracing, systemic or injected medications;
6. Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures;
7. 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 Criteria:

1. Three or more motion segments to be fused;
2. Degenerative scoliosis, defined as Cobb angle \> 10° at any level in lumbar spine;
3. Has had a previous interbody fusion or posterolateral fusion attempt at any level of the lumbar spine;
4. Active systemic or local infection;
5. Known or documented history of communicable disease, including AIDS and HIV;
6. Active Hepatitis (receiving medical treatment within two years);
7. 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;
8. Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for \> 1 month within last 12 months;
9. Known history of Paget's disease, osteomalacia, or any other metabolic bone disease;
10. 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.
11. Morbid obesity defined as a body mass index \> 40 kg/m2 or weight more than 100 pounds over ideal body weight;
12. 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;
13. Current or recent history (within last 2 years) of substance abuse (e.g., recreational drugs, narcotics, or alcohol);
14. Pregnant or planning to become pregnant during study period;
15. Involved in study of another investigational product that may affect outcome;
16. History of psychosocial disorders that could prevent accurate completion of self reporting assessment scales;
17. Patients who are incarcerated.

Primary outcomes:
measure: Posterolateral Fusion Success
timeFrame: Month 24
Secondary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: Month 24
measure: Percent Change in Oswestry Disability Index (ODI)
timeFrame: Month 24
measure: Back Pain on Visual Analog Scale
timeFrame: Month 24
measure: Percent Change in Back Pain on Visual Analog Scale
timeFrame: Month 24
measure: Leg Pain on Visual Analog Scale
timeFrame: Month 24
measure: Percent Change in Leg Pain on Visual Analog Scale
timeFrame: Month 24
measure: Short Form 12 (SF-12v2) Physical Component Summary (PCS)
timeFrame: Month 24
measure: Percent Change in Short Form 12 (SF-12v2) Physical Component Summary (PCS)
timeFrame: Month 24
measure: Short Form 12 (SF-12v2) Mental Component Summary (MCS)
timeFrame: Month 24
measure: Percent Change in Short Form 12 (SF-12v2) Mental Component Summary (MCS)
timeFrame: Month 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Brandon
country: United States
facility: Bay Area Neurosurgery
state: Florida
city: Decatur
country: United States
facility: Atlanta Neurosurgical Associates
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Newton
country: United States
facility: The Boston Spine Group
state: Massachusetts
city: Johnson City
country: United States
facility: Southern New York Neurosurgical Group
state: New York
city: Philadelphia
country: United States
facility: The Rothman Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Dept. of Neurosurgery
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center Department of Neurosurgery/Spine Research
state: Tennessee
city: Newport News
country: United States
facility: Orthopaedic and Spine Center
state: Virginia
Study officials:
References: