The OsteoStrand Plus Deformity Study

March 30, 2023 updated by: SeaSpine, Inc.
A clinical study evaluating outcomes for patients with spinal deformity.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

A clinical study evaluating deformity patients treated with Demineralized Bone Matrix as compared to patients treated with Bone Morphogenetic Protein.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85281
        • Sonoran Spine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Demineralized Bone Matrix
Prospective cohort subjects undergoing deformity correction surgery that receive Demineralized Bone Matrix (DBM).
Procedure: Posterolateral Lumbar Fusion with Demineralized Bone Fibers
Posterolateral Lumbar Fusion with Demimeralized Bone Fibers
Active Comparator: Bone Morphogenic Protein
Retrospective cohort subjects that underwent deformity correction surgery and received Bone Morphogenic Protein (BMP).
Procedure: Posterolateral Lumbar Fusion with Bone Morphogenic Protein
Posterolateral Lumbar Fusion with Bone Morphogenic Protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of fusion for the demineralized bone matrix cohort vs bone morphogenic protein cohort
Time Frame: 12 Months
Proportion of spinal levels in the demineralized bone matrix cohort vs bone morphogenic protein cohort achieving fusion.
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcomes
Time Frame: 24 Months
Oswestry Disability Index (ODI)
24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SeaSpine, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2020

Primary Completion (Anticipated)

March 31, 2024

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

November 5, 2020

First Submitted That Met QC Criteria

November 10, 2020

First Posted (Actual)

November 16, 2020

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SS-OS-1802

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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