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SpineJack System Postmarket Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04795765
Recruitment Status : Recruiting
First Posted : March 12, 2021
Last Update Posted : October 5, 2021
Sponsor:
Collaborator:
Talosix
Information provided by (Responsible Party):
Stryker Instruments

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

Condition or disease Intervention/treatment
Osteoporotic Vertebral Compression Fractures Procedure: SpineJack system Procedure: Balloon kyphoplasty Procedure: Vertebroplasty

Detailed Description:
The SpineJack System Registry will employ a prospective, multicenter, observational, consecutive enrollment design. The sample size for this Registry will include at least 500 patients treated for VCFs across approximately 10 sites. A total of 300 patients will be treated with the SpineJack system and 200 patients will be treated with other vertebral augmentation (VA) procedures, such as BKP or VP. Sites within the U.S. may include healthcare professionals (HCPs) that are surgeons, pain physicians and/or interventional radiologists.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Prospective SpineJack System Registry
Actual Study Start Date : August 19, 2019
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : December 2023
Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients treated with SpineJack system
SpineJack system procedure
 Procedure: SpineJack system
For use in the reduction of painful osteoporotic vertebral compression fractures.
Patients treated with vertebral augmentation
Vertebral augmentation procedures may include either balloon kyphoplasty (BKP) or vertebroplasty (VP).
 Procedure: Balloon kyphoplasty
Treatment of osteoporotic vertebral compression fractures.

Procedure: Vertebroplasty
Treatment of osteoporotic vertebral compression fractures.


Outcome Measures
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Primary Outcome Measures :
  1. Back pain [ Time Frame: 12 months ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All eligible patients that meet inclusion criteria.
Criteria

Inclusion Criteria:

  1. 18 years of age or older
  2. Understand and sign the informed consent form (as applicable)
  3. Exhibit no altered mental status or language barrier that may prevent completion of the patient reported outcome (PRO) surveys following the procedure.
  4. VCF diagnosis made and/or confirmed at participating site.

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04795765


Contacts
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Contact: Theodora Siettas 1-269-254-3837 theodora.siettas@stryker.com
Contact: Jessica Ward jessica.ward@stryker.com

Locations
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United States, California
San Diego Neurosurgery Recruiting
San Diego, California, United States, 92037
Contact: Kevin Yoo, MD         
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03766
Contact: Sword Cambron, MD         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Allan Brook, MD         
Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Contact: Reade De Leacy, MD         
United States, Oklahoma
Summit Medical Center Recruiting
Edmond, Oklahoma, United States, 73013
Contact: Douglas Beall, MD         
United States, Washington
Center for Diagnostic Imaging Recruiting
Federal Way, Washington, United States, 98003
Contact: Kerry Schumacher, MD         
Rainier Orthopedic Institute Recruiting
Puyallup, Washington, United States, 98374
Contact: Neal Shonnard, MD         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Sean Tutton, MD         
Sponsors and Collaborators
Stryker Instruments
Talosix
More Information
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Responsible Party: Stryker Instruments
ClinicalTrials.gov Identifier: NCT04795765    
Other Study ID Numbers: SISSJS2019US
First Posted: March 12, 2021    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: October 2021

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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.: No
Additional relevant MeSH terms:
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Fractures, Compression
Fractures, Bone
Wounds and Injuries