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

NCT ID: NCT00943384

Last Updated: 2014-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2013-10-31

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.

Conditions

Degeneration of Lumbar Intervertebral Disc

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

chronOS Strip

Intervention Type: DEVICE

chronOS strip combined with bone marrow aspirate plus local bone

Interventions

chronOS Strip

chronOS strip combined with bone marrow aspirate plus local bone

Intervention Type: DEVICE

Other Intervention Names

beta-tricalcium phosphate

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Synthes USA HQ, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

Other Identifiers

chronOS-050709

Identifier Type: -

Identifier Source: org_study_id