Status:
COMPLETED
OsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion
Lead Sponsor:
SeaSpine, Inc.
Conditions:
Degenerative Changes
Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 posterolate...
Eligibility Criteria
Inclusion
- Are 18 (eighteen) years of age or older at the time of surgery.
- 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.
- 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.
- Are unresponsive to conservative care over a period of at least 6 months or have signs and/or symptoms that mandate urgent surgical intervention.
- Are willing and able to sign study specific informed consent.
Exclusion
- 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.
- 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.
- Are being treated with radiotherapy.
- 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).
- Are pregnant, lactating or women wishing to become pregnant.
- Are a prisoner.
- BMI ≥ 40
- Are smokers and/or nicotine/tobacco users
- 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.
- 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.
- 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).
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01873586
Start Date
October 1 2012
End Date
October 1 2016
Last Update
June 17 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sherban Orthopaedic and Spine Surgery, PLLC
Kenmore, New York, United States, 14217