NCT04795765

Brief Summary

This postmarket registry is intended to prospectively collect real world data to support ongoing safety and performance of the SpineJack system.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
261

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Longer than P75 for all trials

Geographic Reach
1 country

12 active sites

Status
completed

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

August 19, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2024

Completed
Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

5.2 years

First QC Date

March 9, 2021

Last Update Submit

December 5, 2024

Conditions

Osteoporotic Vertebral Compression Fractures

Outcome Measures

Primary Outcomes (6)

  • Back pain

    The numeric rating scale consists of an eleven-point scale used for patient self-reporting of back pain, which ranges from 0 (no pain) to 10 (the worst pain imaginable).

    12 months post-procedure

  • Radiological outcomes

    Vertebral body height restoration

    Immeditely post-procedure

  • Radiological outcomes

    Adjacent level fractures

    Immediately post-procedure

  • Adverse events

    1. Incidence of adverse device effects (ADEs) and serious adverse device effects (SADEs) requiring surgical re-intervention or re-treatment at the treated level 2. Incidence of unanticipated ADEs 3. Incidence of procedure-related AEs

    12 months post-procedure

  • Quality of life indices - Roland Morris Disability Questionnaire (RMDQ)

    24-item self-report questionnaire used in patients with mild to moderate disability due to acute, sub-acute or chronic low back pain

    12 months post-procedure

  • Patient-Reported Outcomes Measurement Information System (PROMIS Global-10)

    10-item questionnaire that is used to assess general domains of health and functioning, including overall physical health, mental health, social health, pain, fatigue and overall perceived quality of life

    12 months post-procedure

Study Arms (2)

Patients treated with SpineJack system

SpineJack system procedure

Procedure: SpineJack system

Patients treated with vertebral augmentation

Vertebral augmentation procedures may include either balloon kyphoplasty (BKP) or vertebroplasty (VP).

Procedure: Balloon kyphoplastyProcedure: Vertebroplasty

Interventions

SpineJack systemPROCEDURE

For use in the reduction of painful osteoporotic vertebral compression fractures.

Patients treated with SpineJack system
Balloon kyphoplastyPROCEDURE

Treatment of osteoporotic vertebral compression fractures.

Patients treated with vertebral augmentation
VertebroplastyPROCEDURE

Treatment of osteoporotic vertebral compression fractures.

Patients treated with vertebral augmentation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All eligible patients that meet inclusion criteria.

You may qualify if:

  • years of age or older
  • Understand and sign the informed consent form (as applicable)
  • Exhibit no altered mental status or language barrier that may prevent completion of the patient reported outcome (PRO) surveys following the procedure.
  • VCF diagnosis made and/or confirmed at participating site.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

San Diego Neurosurgery

Encinitas, California, 92024, United States

Location

California Orthopedics and Spine

Larkspur, California, 94939, United States

Location

Cleveland Clinic

Stuart, Florida, 34994, United States

Location

St. Luke's IntermountainResearch Center

Boise, Idaho, 83702, United States

Location

Dartmouth Hitchcock

Lebanon, New Hampshire, 03756, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Clinical Investigations

Edmond, Oklahoma, 73013, United States

Location

Center for Diagnostic Imaging (CDI)

Puyallup, Washington, 98373, United States

Location

Rainier Orthopedic Institute

Puyallup, Washington, 98374, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Interventions

KyphoplastyVertebroplasty

Intervention Hierarchy (Ancestors)

CementoplastyOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2021

First Posted

March 12, 2021

Study Start

August 19, 2019

Primary Completion

November 11, 2024

Study Completion

November 11, 2024

Last Updated

December 10, 2024

Record last verified: 2024-12

Locations

US(12)