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The OsteoStrand Plus Deformity Study

Primary Purpose

Spinal Fusion

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Posterolateral Lumbar Fusion with Demineralized Bone Fibers
Posterolateral Lumbar Fusion with Bone Morphogenic Protein
Sponsored by
SeaSpine, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Fusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-≥18 years of age

  • Indicated for deformity correction surgery
  • Require spinal fusion at four or more levels
  • Are willing to return for follow-up visits
  • Willing to sign the Informed Consent Forms

Exclusion Criteria:

  • Uncontrolled diabetes
  • Morbid obesity
  • history of alcohol or drug abuse
  • Corticosteroid use
  • Fever or leukocytosis
  • Systemic infection
  • Active malignancy
  • Elevation of white blood cell count
  • Osteoporosis
  • Disease of bone metabolism
  • Unsuitable or insufficient bone support
  • Skeletal immaturity
  • Prior fusion
  • Use of steroids, immune suppressants, osteoporosis medications
  • Use of internal bone stimulators
  • Institutionalized or a prisoner
  • Undergoing (Undergone) a worker's compensation case
  • Pregnancy (includes women who are currently pregnant, lactating or wishing to become pregnant during the study duration)
  • Participation in another research study involving another implant, product or drug that may affect the outcomes of this clinical study within the last 30 days, or planned during this clinical study
  • Any other condition that the Investigator determines is unacceptable for enrollment into this clinical study

Sites / Locations

  • Sonoran Spine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Demineralized Bone Matrix

Bone Morphogenic Protein

Arm Description

Prospective cohort subjects undergoing deformity correction surgery that receive Demineralized Bone Matrix (DBM).

Retrospective cohort subjects that underwent deformity correction surgery and received Bone Morphogenic Protein (BMP).

Outcomes

Primary Outcome Measures

Assessment of fusion for the demineralized bone matrix cohort vs bone morphogenic protein cohort
Proportion of spinal levels in the demineralized bone matrix cohort vs bone morphogenic protein cohort achieving fusion.

Secondary Outcome Measures

Clinical outcomes
Oswestry Disability Index (ODI)

Full Information

First Posted
November 5, 2020
Last Updated
March 30, 2023
Sponsor
SeaSpine, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04629794
Brief Title
The OsteoStrand Plus Deformity Study
Official Title
The OsteoStrand Plus Deformity Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 5, 2020 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SeaSpine, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
A clinical study evaluating outcomes for patients with spinal deformity.
Detailed Description
A clinical study evaluating deformity patients treated with Demineralized Bone Matrix as compared to patients treated with Bone Morphogenetic Protein.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Fusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Demineralized Bone Matrix
Arm Type
Active Comparator
Arm Description
Prospective cohort subjects undergoing deformity correction surgery that receive Demineralized Bone Matrix (DBM).
Arm Title
Bone Morphogenic Protein
Arm Type
Active Comparator
Arm Description
Retrospective cohort subjects that underwent deformity correction surgery and received Bone Morphogenic Protein (BMP).
Intervention Type
Procedure
Intervention Name(s)
Posterolateral Lumbar Fusion with Demineralized Bone Fibers
Intervention Description
Posterolateral Lumbar Fusion with Demimeralized Bone Fibers
Intervention Type
Procedure
Intervention Name(s)
Posterolateral Lumbar Fusion with Bone Morphogenic Protein
Intervention Description
Posterolateral Lumbar Fusion with Bone Morphogenic Protein
Primary Outcome Measure Information:
Title
Assessment of fusion for the demineralized bone matrix cohort vs bone morphogenic protein cohort
Description
Proportion of spinal levels in the demineralized bone matrix cohort vs bone morphogenic protein cohort achieving fusion.
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Clinical outcomes
Description
Oswestry Disability Index (ODI)
Time Frame
24 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: -≥18 years of age Indicated for deformity correction surgery Require spinal fusion at four or more levels Are willing to return for follow-up visits Willing to sign the Informed Consent Forms Exclusion Criteria: Uncontrolled diabetes Morbid obesity history of alcohol or drug abuse Corticosteroid use Fever or leukocytosis Systemic infection Active malignancy Elevation of white blood cell count Osteoporosis Disease of bone metabolism Unsuitable or insufficient bone support Skeletal immaturity Prior fusion Use of steroids, immune suppressants, osteoporosis medications Use of internal bone stimulators Institutionalized or a prisoner Undergoing (Undergone) a worker's compensation case Pregnancy (includes women who are currently pregnant, lactating or wishing to become pregnant during the study duration) Participation in another research study involving another implant, product or drug that may affect the outcomes of this clinical study within the last 30 days, or planned during this clinical study Any other condition that the Investigator determines is unacceptable for enrollment into this clinical study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Chang, MD
Organizational Affiliation
Sonoran Spine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sonoran Spine
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85281
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The OsteoStrand Plus Deformity Study

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