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

NCT00943384 | Completed Results

• 1 other identifier: chronOS-050709
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 13

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

Outcome Measures

Primary Outcomes (1)

• Posterolateral Fusion Success

  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.

  Month 24

Secondary Outcomes (10)

• Oswestry Disability Index (ODI)

  Month 24

• Percent Change in Oswestry Disability Index (ODI)

  Month 24

• Back Pain on Visual Analog Scale

  Month 24

• Percent Change in Back Pain on Visual Analog Scale

  Month 24

• Leg Pain on Visual Analog Scale

  Month 24

Study Arms (1)

chronOS Strip

EXPERIMENTAL

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

Interventions

chronOS Strip DEVICE

chronOS strip combined with bone marrow aspirate plus local bone

Also known as: beta-tricalcium phosphate

chronOS Strip

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;
• 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;

Sponsors & Collaborators

• Synthes USA HQ, Inc.: lead

Study Sites (13)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Bay Area Neurosurgery

Brandon, Florida, 33511, United States

Location

Atlanta Neurosurgical Associates

Decatur, Georgia, 30033, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

The Boston Spine Group

Newton, Massachusetts, 02458, United States

Location

Southern New York Neurosurgical Group

Johnson City, New York, 13790, United States

Location

The Rothman Institute

Philadelphia, Pennsylvania, 19020, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

Location

UPMC Presbyterian Dept. of Neurosurgery

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt University Medical Center Department of Neurosurgery/Spine Research

Nashville, Tennessee, 37232, United States

Location

Orthopaedic and Spine Center

Newport News, Virginia, 23606, United States

Location

Limitations and Caveats

Limitations included lack of control arm, no hypothesis for primary endpoint, \& qualitative sample size estimate. chronOS Strip was used according to its FDA-cleared labeling; other usage was outside the study scope and was not evaluated clinically.

Results Point of Contact

• Title: Allyson Morris, PhD, CCRP, Staff Clinical Research Scientist
• Organization: DePuy Synthes Clinical Affairs

morris.allyson@synthes.com

610-719-5298

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2009
• First Posted: July 22, 2009
• Study Start: July 1, 2009
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 26, 2014
• Results First Posted: November 26, 2014

Record last verified: 2014-11

Locations

US (13)