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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Synthes USA HQ, Inc.
ClinicalTrials.gov Identifier:
NCT00943384
First received: July 21, 2009
Last updated: November 18, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
Degeneration of Lumbar Intervertebral Disc
Device: chronOS Strip

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Synthes USA HQ, Inc.:

Primary Outcome Measures:
  • Posterolateral Fusion Success [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    The primary outcome for posterolateral fusion status was a composite endpoint incorporating posterior bridging bone status, intersegmental motion (angular and translational motion) and posterior hardware status. To have successful posterolateral fusion, a subject had to be successful in all four components at all levels under investigation. Failure to meet any one of the four components indicated failed posterolateral fusion status.


Secondary Outcome Measures:
  • Oswestry Disability Index (ODI) [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    The Oswestry Low Back Pain Disability Questionnaire was self-administered to each subject preoperatively and at each clinical follow up examination. Each of the ten questions had six ordered responses coded on a scale from zero to five. The scale ranges from 0-100. A higher score indicates a higher level of disability, and a negative percent change (post surgery minus baseline) indicates improved function.

  • Percent Change in Oswestry Disability Index (ODI) [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    The Oswestry Low Back Pain Disability Questionnaire was self-administered to each subject preoperatively and at each clinical follow up examination. Each of the ten questions had six ordered responses coded on a scale from zero to five. The scale ranges from 0-100. A higher score indicates a higher level of disability, and a negative percent change (post surgery minus baseline) indicates improved function. Percent change in ODI score was calculated as: [(Month 24-Baseline)/Baseline]*100%.

  • Back Pain on Visual Analog Scale [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    The subjects completed questionnaires assessing the intensity of pain experienced in the back at the preoperative visit and at all visits postoperatively. Pain intensity was rated on a scale where zero indicated no pain, and 100 represented the worst possible pain.

  • Percent Change in Back Pain on Visual Analog Scale [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    The subjects completed questionnaires assessing the intensity of pain experienced in the back at the preoperative visit and at all visits postoperatively. Pain intensity was rated on a scale where zero indicated no pain, and 100 represented the worst possible pain. A negative change (post surgery minus baseline) indicated an improvement. Percent change was calculated as: [(Month 24-Baseline)/Baseline]*100%.

  • Leg Pain on Visual Analog Scale [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    The subjects completed questionnaires assessing the intensity of pain experienced in the leg at the preoperative visit and at all visits postoperatively. Pain intensity was rated on a scale where zero indicated no pain, and 100 represented the worst possible pain.

  • Percent Change in Leg Pain on Visual Analog Scale [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    The subjects completed questionnaires assessing the intensity of pain experienced in the leg at the preoperative visit and at all visits postoperatively. Pain intensity was rated on a scale where zero indicated no pain, and 100 represented the worst possible pain. A negative change (post surgery minus baseline) indicated an improvement. Percent change was calculated as: [(Month 24-Baseline)/Baseline]*100%.

  • Short Form 12 (SF-12v2) Physical Component Summary (PCS) [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    The SF-12v2, comprising 12 questions related to health and wellbeing over the prior four weeks, was administered to subjects preoperatively and at all follow up visits. SF-12v2 represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. First, the eight scales were standardized using means and standard deviations (SD) for the general US population. Second, PCS was scored by aggregating the eight scales using a standardized algorithm. Finally, PCS was standardized using a linear t-score transformation to have a mean of 50 and a SD of 10 in the general US population (expected range: 13-69).

  • Percent Change in Short Form 12 (SF-12v2) Physical Component Summary (PCS) [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    The SF-12v2, comprising 12 questions related to health and wellbeing over the prior four weeks, was administered to subjects preoperatively and at all follow up visits. SF-12v2 represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. First, the eight scales were standardized using means and standard deviations (SD) for the general US population. Second, PCS was scored by aggregating the eight scales using a standardized algorithm. Finally, PCS was standardized using a linear t-score transformation to have a mean of 50 and a SD of 10 in the general US population (expected range: 13-69). Percent change was calculated as [(Month 24 - Baseline)/Baseline]*100%.

  • Short Form 12 (SF-12v2) Mental Component Summary (MCS) [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    The SF-12v2, comprising 12 questions related to health and wellbeing over the prior four weeks, was administered to subjects preoperatively and at all follow up visits. SF-12v2 represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. First, the eight scales were standardized using means and standard deviations (SD) for the general US population. Second, MCS was scored by aggregating the eight scales using a standardized algorithm. Finally, MCS was standardized using a linear t-score transformation to have a mean of 50 and a SD of 10 in the general US population (expected range: 10-70).

  • Percent Change in Short Form 12 (SF-12v2) Mental Component Summary (MCS) [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    The SF-12v2, comprising 12 questions related to health and wellbeing over the prior four weeks, was administered to subjects preoperatively and at all follow up visits. SF-12v2 represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. First, the eight scales were standardized using means and standard deviations (SD) for the general US population. Second, MCS was scored by aggregating the eight scales using a standardized algorithm. Finally, MCS was standardized using a linear t-score transformation to have a mean of 50 and a SD of 10 in the general US population (expected range: 10-70). Percent change was calculated as [(Month 24 - Baseline)/Baseline]*100%.


Enrollment: 104
Study Start Date: July 2009
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: chronOS Strip
This is a single arm, outcome study for treatment of patients with degenerative disc disease (DDD), with or without stenosis, with interbody fusion, posterolateral pedicle screw system, and the study device (chronOS Strip).
Device: chronOS Strip
chronOS strip combined with bone marrow aspirate plus local bone
Other Name: beta-tricalcium phosphate

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00943384

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
United States, Florida
Bay Area Neurosurgery
Brandon, Florida, United States, 33511
United States, Georgia
Atlanta Neurosurgical Associates
Decatur, Georgia, United States, 30033
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Massachusetts
The Boston Spine Group
Newton, Massachusetts, United States, 02458
United States, New York
Southern New York Neurosurgical Group
Johnson City, New York, United States, 13790
United States, Pennsylvania
The Rothman Institute
Philadelphia, Pennsylvania, United States, 19020
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
UPMC Presbyterian Dept. of Neurosurgery
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Vanderbilt University Medical Center Department of Neurosurgery/Spine Research
Nashville, Tennessee, United States, 37232
United States, Virginia
Orthopaedic and Spine Center
Newport News, Virginia, United States, 23606
Sponsors and Collaborators
Synthes USA HQ, Inc.
  More Information

No publications provided

Responsible Party: Synthes USA HQ, Inc.
ClinicalTrials.gov Identifier: NCT00943384     History of Changes
Other Study ID Numbers: chronOS-050709
Study First Received: July 21, 2009
Results First Received: October 21, 2014
Last Updated: November 18, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases

ClinicalTrials.gov processed this record on November 25, 2014