Patient Outcomes Using an Expandable Spacer

Post-market Surveillance Study of Altera™ Minimally Invasive Articulating Expandable Spacer in a TLIF Interbody Fusion Device

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.

Study Overview

• Status: Withdrawn
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: 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

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients that present to Rush University Medical Center

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Radiographic Analysis	Global and Segmental Lumbar Lordosis in degrees	Pre-Op, 6weeks, 12 weeks, 6months, 12 months, 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Surgical or device related complications	Intra-operative, any time post-op upto 24 months
Change in Patient Reported Outcomes as a number score	Visual Analog Scale, Oswestry Disability Index, Short Form 12, PROMIS	Pre-Op, 6weeks, 12 weeks, 6months, 12 months, 24 months
Peri operative clinical parameters	Estimated Blood Loss in cc	Intra-Operative
Clinical parameters in days	Length of Hospital Stay	Immediate Post-operative
Peri operative clinical parameters in mgs	Narcotic Consumption	Immediate Post-operative
Intra-Operative clinical parameters in minutes	Operative Time	Intra-Operative
Changes in Radiographic Analysis in percentage	Fusion Rates	6weeks, 12 weeks, 6months, 12 months, 24 months

Collaborators and Investigators

• Sponsor: Globus Medical Inc
• Investigators: Principal Investigator: Kern Singh, MD, Rush Univeristy Medical Center Orthopedic Surgeon

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 28, 2017
• Primary Completion (ANTICIPATED): November 6, 2020
• Study Completion (ANTICIPATED): November 6, 2020

Study Registration Dates

• First Submitted: May 17, 2017
• First Submitted That Met QC Criteria: May 19, 2017
• First Posted (ACTUAL): May 22, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 23, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: RGC16-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No