Clinical trial NCT03162666: Patient Outcomes Using an Expandable Spacer
Official title: Post-market Surveillance Study of Altera™ Minimally Invasive Articulating Expandable Spacer in a TLIF Interbody Fusion Device
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Degenerative Disc Disease
Lead sponsor: Globus Medical Inc
Sponsor class: INDUSTRY
First posted: 2017-05-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that present to Rush University Medical Center

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.

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

Eligibility 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

Primary outcomes:
measure: Change in Radiographic Analysis
timeFrame: Pre-Op, 6weeks, 12 weeks, 6months, 12 months, 24 months
Secondary outcomes:
measure: Complications
timeFrame: Intra-operative, any time post-op upto 24 months
measure: Change in Patient Reported Outcomes as a number score
timeFrame: Pre-Op, 6weeks, 12 weeks, 6months, 12 months, 24 months
measure: Peri operative clinical parameters
timeFrame: Intra-Operative
measure: Clinical parameters in days
timeFrame: Immediate Post-operative
measure: Peri operative clinical parameters in mgs
timeFrame: Immediate Post-operative
measure: Intra-Operative clinical parameters in minutes
timeFrame: Intra-Operative
measure: Changes in Radiographic Analysis in percentage
timeFrame: 6weeks, 12 weeks, 6months, 12 months, 24 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush Univeristy Medical Center Orthopedic Surgeon
name: Kern Singh, MD
role: PRINCIPAL_INVESTIGATOR
References: