Patient Outcomes Using an Expandable Spacer

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03162666
• Other study ID #: RGC16-001
• Status: Withdrawn
• Start date: February 28, 2017
• Est. completion date: November 6, 2020

Study information

• Verified date: September 2020
• Source: Globus Medical Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 6, 2020
• Est. primary completion date: November 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

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

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Globus Medical Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Radiographic Analysis	Global and Segmental Lumbar Lordosis in degrees	Pre-Op, 6weeks, 12 weeks, 6months, 12 months, 24 months
Secondary	Complications	Surgical or device related complications	Intra-operative, any time post-op upto 24 months
Secondary	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
Secondary	Peri operative clinical parameters	Estimated Blood Loss in cc	Intra-Operative
Secondary	Clinical parameters in days	Length of Hospital Stay	Immediate Post-operative
Secondary	Peri operative clinical parameters in mgs	Narcotic Consumption	Immediate Post-operative
Secondary	Intra-Operative clinical parameters in minutes	Operative Time	Intra-Operative
Secondary	Changes in Radiographic Analysis in percentage	Fusion Rates	6weeks, 12 weeks, 6months, 12 months, 24 months