Clinical trial NCT01873586: OsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion
Official title: Efficacy and Safety of OsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Changes
Stenosis
Spondylosis
Lead sponsor: SeaSpine, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-10
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of this study is to prospectively evaluate the performance of Integra's OsteoStrux Collagen Ceramic Scaffold combined with bone marrow aspirate as an adjunct for instrumented posterolateral spine fusion, as compared to local autograft.


Eligibility criteria: Inclusion Criteria:

1. Are 18 (eighteen) years of age or older at the time of surgery.
2. Require spinal fusion using TLIF, PLF or PLIF, with or without the use of an interbody spacer, at 1 to 3 levels between L3-S1.
3. Are willing and able to return for the scheduled follow-up visits, follow post-operative instructions and undergo the required radiographic exams (A/P, Lateral Neutral and Lateral Flexion/Extension X-rays) for up to 4 time points between 3 weeks and 12 months post-surgery (3 months ± 2 weeks, 6±1 months, 12±2 months and if required 24±3 months post-surgery), including one CT-scan at 12±2 months.
4. Are unresponsive to conservative care over a period of at least 6 months or have signs and/or symptoms that mandate urgent surgical intervention.
5. Are willing and able to sign study specific informed consent.

Exclusion Criteria:

1. Are long term users of medications (i.e. steroids greater than 8 days) that are known to inhibit fusion or bone metabolism at any time within 6 months prior to surgery. Exceptions are inhaled steroids for asthma treatment (i.e. patients on inhaled steroids are allowed), or epidural steroid injections.
2. Are taking immunosuppressive agents (Cancer chemotherapy, treatment with Disease Modifying Anti-rheumatic drugs (DMARDs) or any similar immunomodulating drugs) or are treated with Growth Factors or Insulin at any time within 6 months prior to surgery.
3. Are being treated with radiotherapy.
4. Are having medical conditions, known to impact bone metabolism, such as Paget's disease, or has established osteoporosis (i.e. has had one or more fragility fractures).
5. Are pregnant, lactating or women wishing to become pregnant.
6. Are a prisoner.
7. BMI ≥ 40
8. Are smokers and/or nicotine/tobacco users
9. Are currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the study endpoints.
10. Had prior spine surgery at the index level except posterior decompressive surgery where the posterior elements are preserved e.g. facet saving techniques such as discectomy, laminotomy, and intradiscal procedures.
11. Use of routine prophylactic NSAIDS for 3 months post-operatively, but low dose concomitant pain medications e.g. aspirin should be continued and recorded on the Concomitant Pain Medications case report form (CRF).

Primary outcomes:
measure: Number of Posterolateral Gutters That Have Evidence of Arthrodesis (Fusion) at 3, 6, 12, and 24 Months, as Measured by X-rays.
timeFrame: up to 24 months
Secondary outcomes:
measure: Number of Posterolateral Gutters Showing Evidence of Arthrodesis (Fusion) as Measured by CT
timeFrame: 12 months
measure: Interbody Fusion as Determined by X-ray at 3, 6, 12 and 24 Months
timeFrame: upto 24 months
measure: Interbody Fusion as Determined by CT Post-surgery at Available Time-points
timeFrame: 12 months
measure: EQ-5D Health State Visual Analog Scale (VAS) Questionnaire at All Available Time-points
timeFrame: upto 24 months
measure: Number of Posterolateral Levels With Correlation of Fusion Ratings by X-ray and CT Scan
timeFrame: 12 months
measure: Medical Outcomes: Oswestry Disability Index (ODI), at All Available Time-points.
timeFrame: upto 24 months
measure: Medical Outcomes: Worst Leg Pain on the Visual Analog Scale (VAS) at All Available Time-points.
timeFrame: upto 24 months
measure: Medical Outcomes: Visual Analog Scale (VAS) Back Pain at All Available Time-points.
timeFrame: upto 24 months
measure: Medical Outcomes: Maintenance of Lower Extremity Neurological Function at All Available Time-points.
timeFrame: upto 24 months
Other outcomes:
Locations:
city: Kenmore
country: United States
facility: Sherban Orthopaedic and Spine Surgery, PLLC
state: New York
Study officials:
affiliation: Sherban Orthopaedic and Spine Surgery, PLLC
name: Ross Sherban, DO
role: PRINCIPAL_INVESTIGATOR
References: