OsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion

NCT01873586 | Completed Results

• 1 other identifier: OSX-US-2012-1
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of Posterolateral Gutters That Have Evidence of Arthrodesis (Fusion) at 3, 6, 12, and 24 Months, as Measured by X-rays.

  Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).

  up to 24 months

Secondary Outcomes (9)

• Number of Posterolateral Gutters Showing Evidence of Arthrodesis (Fusion) as Measured by CT

  12 months

• Interbody Fusion as Determined by X-ray at 3, 6, 12 and 24 Months

  upto 24 months

• Interbody Fusion as Determined by CT Post-surgery at Available Time-points

  12 months

• EQ-5D Health State Visual Analog Scale (VAS) Questionnaire at All Available Time-points

  upto 24 months

• Number of Posterolateral Levels With Correlation of Fusion Ratings by X-ray and CT Scan

  12 months

Study Arms (2)

OsteoStrux Collagen Ceramic Scaffold

EXPERIMENTAL

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

Procedure: Posterolateral Fusion

Local autograft

ACTIVE COMPARATOR

Local autograft (posterolateral gutter at the contralateral side)

Procedure: Posterolateral Fusion

Interventions

Posterolateral Fusion PROCEDURE

Local autograft; OsteoStrux Collagen Ceramic Scaffold

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• SeaSpine, Inc.: lead

Study Sites (1)

Sherban Orthopaedic and Spine Surgery, PLLC

Kenmore, New York, 14217, United States

Location

MeSH Terms

Conditions

Constriction, Pathologic; Spondylosis

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Limitations and Caveats

The following outcomes were unable to be analyzed due to the limitations of the protocol and analysis design and the inability to distinguish differences in posterolateral gutter analysis; neurological function and interbody fusion assessments.

Results Point of Contact

• Title: Director Clinical Affairs
• Organization: SeaSpine

tish.mikoczi@seaspine.com

Study Officials

• Ross Sherban, DO

  Sherban Orthopaedic and Spine Surgery, PLLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: June 10, 2013
• Study Start: October 1, 2012
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: June 17, 2019
• Results First Posted: June 17, 2019

Record last verified: 2019-03

Locations

US (1)