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Patient Outcomes Using an Expandable Spacer

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ClinicalTrials.gov Identifier: NCT03162666
Recruitment Status : Not yet recruiting
First Posted : May 22, 2017
Last Update Posted : May 22, 2017
Sponsor:
Information provided by (Responsible Party):
Globus Medical Inc

Brief Summary:
This study is a post-market clinical follow-up study. The data collected from this study will serve the purpose of confirming safety and performance of the ALTERA™ Expandable implant.

Condition or disease Intervention/treatment
Degenerative Disc Disease Device: ALTERA

Detailed Description:

The evaluation is based on the following elements.

  1. Safety as measured by the rate of serious operative and post-operative complications.
  2. Subjects quality of life, measured by health-related quality of life questionnaires and Subject-reported outcome measures up to 24 months following the procedure, as compared to Subject's preoperative baseline.
  3. Global and segmental lumbar lordosis (LL)

Patients will be followed upto 24 months post-operative


Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-market Surveillance Study of Altera™ Minimally Invasive Articulating Expandable Spacer in a TLIF Interbody Fusion Device
Estimated Study Start Date : May 25, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: ALTERA
    degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. with up to grade 1 spondylolisthesis


Primary Outcome Measures :
  1. Change in Radiographic Analysis [ Time Frame: Pre-Op, 6weeks, 12 weeks, 6months, 12 months, 24 months ]
    Global and Segmental Lumbar Lordosis in degrees


Secondary Outcome Measures :
  1. Complications [ Time Frame: Intra-operative, any time post-op upto 24 months ]
    Surgical or device related complications

  2. Change in Patient Reported Outcomes as a number score [ Time Frame: Pre-Op, 6weeks, 12 weeks, 6months, 12 months, 24 months ]
    Visual Analog Scale, Oswestry Disability Index, Short Form 12, PROMIS

  3. Peri operative clinical parameters [ Time Frame: Intra-Operative ]
    Estimated Blood Loss in cc

  4. Clinical parameters in days [ Time Frame: Immediate Post-operative ]
    Length of Hospital Stay

  5. Peri operative clinical parameters in mgs [ Time Frame: Immediate Post-operative ]
    Narcotic Consumption

  6. Intra-Operative clinical parameters in minutes [ Time Frame: Intra-Operative ]
    Operative Time

  7. Changes in Radiographic Analysis in percentage [ Time Frame: 6weeks, 12 weeks, 6months, 12 months, 24 months ]
    Fusion Rates



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients that present to Rush University Medical Center
Criteria

Inclusion Criteria:

  • Adult (18-70 y/o)
  • Male or Female
  • With the following conditions of the lumbar spine as confirmed by advanced imaging (CT or MRI), who is a candidate for primary spinal fusion procedure according to acceptable criteria for such medical conditions:

    • Degenerative disc disease with up to Grade I spondylolisthesis
    • Spondylolisthesis
  • Failure of at least 6-months conservative treatment
  • BMI < 40
  • Subject to approve no pregnancy during the 24 months of study and no participation in other studies in parallel to this one
  • Ability to read, understand, and sign informed consent

Exclusion Criteria:

  • Infection, local to the operative site
  • Signs of local inflammation
  • Fever or leukocytosis
  • Pregnancy
  • Significant mental disorder or condition that could compromise the Subject's ability to remember and comply with preoperative and postoperative instructions (e.g. current treatment for a psychiatric/psychosocial disorder, senile dementia, Alzheimer's disease, traumatic head injury)
  • Prior surgical procedure (with the exception of decompression only procedure) at the index level(s) using the desired operative approach
  • Prior fusion procedure at an adjacent level
  • Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors or congenital abnormalities, fracture local to the operating site, elevation of segmentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count
  • Neuromuscular disorder that would engender unacceptable risk of instability, implant fixation failure, or complications in postoperative care
  • Active local infection in or near the operative region
  • Active systemic infection and/or disease
  • Severe osteoporosis or insufficient bone density, which in the medical opinion of the physician precludes surgery or contraindicates instrumentation
  • Endocrine or metabolic disorders known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, hypothyroidism)
  • Systemic disease that requires the chronic administration of nonsteroidal anti-inflammatory or steroidal drugs
  • Suspected or documented allergy or intolerance to implant's materials
  • Symptomatic cardiac disease
  • Subject unwilling to cooperate with postoperative instructions.
  • Any case where the implant components selected for use would be too large or too small to achieve a successful result.
  • Subject having inadequate tissue coverage over the operative site or inadequate bone stock or quality.
  • Any Subject in which implant utilization would interfere with anatomical structures or expected physiological performance.
  • Prior fusion at the level to be treated.
  • Back VAS < 4/10

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03162666


Contacts
Contact: Gita Joshua 610-930-1800 ext 1826 gjoshua@globusmedical.com
Contact: Susan Dvojack 312.942.6689 Susan_Dvojack@rush.edu

Sponsors and Collaborators
Globus Medical Inc
Investigators
Principal Investigator: Kern Singh, MD Rush Univeristy Medical Center Orthopedic Surgeon

Responsible Party: Globus Medical Inc
ClinicalTrials.gov Identifier: NCT03162666     History of Changes
Other Study ID Numbers: RGC06-001
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: May 22, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

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