NCT04629794

Brief Summary

A clinical study evaluating outcomes for patients with spinal deformity.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

April 4, 2023

Status Verified

March 1, 2023

Enrollment Period

4.1 years

First QC Date

November 5, 2020

Last Update Submit

March 30, 2023

Conditions

Spinal Fusion

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 Months

Secondary Outcomes (1)

  • Clinical outcomes

    24 Months

Study Arms (2)

Demineralized Bone Matrix

ACTIVE COMPARATOR

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

Procedure: Posterolateral Lumbar Fusion with Demineralized Bone Fibers

Bone Morphogenic Protein

ACTIVE COMPARATOR

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

Procedure: Posterolateral Lumbar Fusion with Bone Morphogenic Protein

Interventions

Posterolateral Lumbar Fusion with Demineralized Bone FibersPROCEDURE

Posterolateral Lumbar Fusion with Demimeralized Bone Fibers

Demineralized Bone Matrix
Posterolateral Lumbar Fusion with Bone Morphogenic ProteinPROCEDURE

Posterolateral Lumbar Fusion with Bone Morphogenic Protein

Bone Morphogenic Protein

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sonoran Spine

Tempe, Arizona, 85281, United States

Location

Study Officials

  • Michael Chang, MD

    Sonoran Spine

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 5, 2020

First Posted

November 16, 2020

Study Start

March 5, 2020

Primary Completion

March 31, 2024

Study Completion

June 30, 2024

Last Updated

April 4, 2023

Record last verified: 2023-03

Locations

US(1)