OsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion

NCT ID: NCT01873586

Last Updated: 2019-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2016-10-31

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.

Conditions

Degenerative Changes; Stenosis; Spondylosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

OsteoStrux Collagen Ceramic Scaffold

OsteoStrux Collagen Ceramic Scaffold (posterolateral gutter at the symptomatic side)

Group Type: EXPERIMENTAL

Posterolateral Fusion

Intervention Type: PROCEDURE

Local autograft

Local autograft (posterolateral gutter at the contralateral side)

Group Type: ACTIVE_COMPARATOR

Posterolateral Fusion

Intervention Type: PROCEDURE

Interventions

Posterolateral Fusion

Intervention Type: PROCEDURE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SeaSpine, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ross Sherban, DO

Role: PRINCIPAL_INVESTIGATOR

Sherban Orthopaedic and Spine Surgery, PLLC

Locations

Sherban Orthopaedic and Spine Surgery, PLLC

Kenmore, New York, United States

Countries

United States

Other Identifiers

OSX-US-2012-1

Identifier Type: -

Identifier Source: org_study_id