Overview

This trial is active, not recruiting.

Conditions degenerative changes, stenosis, spondylosis
Treatment osteostrux collagen ceramic scaffold
Sponsor SeaSpine, Inc.
Start date October 2012
End date December 2016
Trial size 30 participants
Trial identifier NCT01873586, OSX-US-2012-1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
OsteoStrux Collagen Ceramic Scaffold
osteostrux collagen ceramic scaffold
OsteoStrux Collagen Ceramic Scaffold

Primary Outcomes

Measure
Time to arthrodesis (fusion) in the posterolateral space for the OsteoStrux Collagen Ceramic Scaffold as measured by X-rays at 3, 6, 12 and 24 months.
time frame: upto 24 months

Secondary Outcomes

Measure
Extent of posterolateral arthrodesis (fusion) as measured by CT
time frame: 12 months
Interbody fusion as determined by X-ray at 3, 6, 12 and 24 months
time frame: upto 24 months
Interbody fusion as determined by CT post-surgery at available time-points
time frame: 12 months
Medical Outcome EQ-5D Questionnaire at all available time-points
time frame: upto 24 months
Correlation of fusion ratings by X-ray and CT scan at available time-points
time frame: 12 months
Serious Adverse Events, Adverse Device Effects, Serious Adverse Device Effects and Subsequent surgical interventions
time frame: 0 to 24 months
Medical Outcomes: Oswestry Disability Index, at all available time-points.
time frame: upto 24 months
Medical Outcomes: Leg pain (VAS) at all available time-points.
time frame: upto 24 months
Medical Outcomes: Back pain (VAS) at all available time-points.
time frame: upto 24 months
Medical Outcomes: Maintenance of lower extremity neurological function at all available time-points.
time frame: upto 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

Official title Efficacy and Safety of OsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion
Principal investigator Ross Sherban, DO
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by SeaSpine, Inc..