Patient Outcomes Using an Expandable Spacer

NCT03162666 | Withdrawn FDA Device

• 1 other identifier: RGC16-001
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

• Change in Radiographic Analysis

  Global and Segmental Lumbar Lordosis in degrees

  Pre-Op, 6weeks, 12 weeks, 6months, 12 months, 24 months

Secondary Outcomes (7)

• Complications

  Intra-operative, any time post-op upto 24 months

• Change in Patient Reported Outcomes as a number score

  Pre-Op, 6weeks, 12 weeks, 6months, 12 months, 24 months

• Peri operative clinical parameters

  Intra-Operative

• Clinical parameters in days

  Immediate Post-operative

• Peri operative clinical parameters in mgs

  Immediate Post-operative

Interventions

ALTERA DEVICE

degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. with up to grade 1 spondylolisthesis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients that present to Rush University Medical Center

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Globus Medical Inc: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Kern Singh, MD

  Rush Univeristy Medical Center Orthopedic Surgeon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 22, 2017
• Study Start: February 28, 2017
• Primary Completion: November 6, 2020
• Study Completion: November 6, 2020
• Last Updated: August 23, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)