Osteoporotic Vertebral Compression FracturesNCT04795765
SpineJack System Postmarket Registry
An observational study of Osteoporotic Vertebral Compression Fractures, run by Stryker Instruments at 12 sites in United States.
Trial summary
This postmarket registry is intended to prospectively collect real world data to support ongoing safety and performance of the SpineJack system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporotic Vertebral Compression Fractures
- What is being tested?
- SpineJack system, Balloon kyphoplasty and Vertebroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 261 participants
- Where
- 12 sitesUnited States
- Study dates
- 19 Aug 2019to 11 Nov 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All eligible patients that meet inclusion criteria.
Who may be able to join
- 18 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.
Who cannot join
- -
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
St. Luke's IntermountainResearch Center
Boise, Idaho, 83702
Clinical Investigations
Edmond, Oklahoma, 73013
San Diego Neurosurgery
Encinitas, California, 92024
California Orthopedics and Spine
Larkspur, California, 94939
Dartmouth Hitchcock
Lebanon, New Hampshire, 03756
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Center for Diagnostic Imaging (CDI)
Puyallup, Washington, 98373
Rainier Orthopedic Institute
Puyallup, Washington, 98374
Cleveland Clinic
Stuart, Florida, 34994
Montefiore Medical Center
The Bronx, New York, 10467
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: Prospective SpineJack System Registry
This postmarket registry is intended to prospectively collect real world data to support ongoing safety and performance of the SpineJack system.
Read the 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 400 patients treated for VCFs across approximately 10 sites. A total of 240 patients will be treated with the SpineJack system and 160 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.
- Being tested
- SpineJack system, Balloon kyphoplasty, Vertebroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpineJack systemProcedure or surgery
For use in the reduction of painful osteoporotic vertebral compression fractures.
Balloon kyphoplastyProcedure or surgery
Treatment of osteoporotic vertebral compression fractures.
VertebroplastyProcedure or surgery
Treatment of osteoporotic vertebral compression fractures.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with SpineJack system | SpineJack system procedure Receives: Procedure: SpineJack system | |
| Patients treated with vertebral augmentation | Vertebral augmentation procedures may include either balloon kyphoplasty (BKP) or vertebroplasty (VP). Receives: Procedure: Balloon kyphoplasty; Procedure: Vertebroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months post-procedure
Radiological outcomes
Vertebral body height restoration
Measured: Immeditely post-procedure
Radiological outcomes
Adjacent level fractures
Measured: Immediately post-procedure
Adverse events
- Incidence of adverse device effects (ADEs) and serious adverse device effects (SADEs) requiring surgical re-intervention or re-treatment at the treated level
- Incidence of unanticipated ADEs
- Incidence of procedure-related AEs
Measured: 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
Measured: 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
Measured: 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start19 Aug 2019
- Primary completion11 Nov 2024
- Study completion11 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporotic Vertebral Compression FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 261 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Stryker Instruments
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Talosix
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795765
- Sponsor's protocol ID
- SISSJS2019US
- Status last verified
- Dec 2024
- First submitted
- 9 Mar 2021
- Last updated
- 10 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective SpineJack System Registry
- ClinicalTrials.gov ID
- NCT04795765
- Acronym / sponsor ID
- SISSJS2019US
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Stryker InstrumentsIndustry (pharma, biotech, devices)
- Collaborators
- Talosix
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 11 Nov 2024 (actual)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This postmarket registry is intended to prospectively collect real world data to support ongoing safety and performance of the SpineJack system.
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 400 patients treated for VCFs across approximately 10 sites. A total of 240 patients will be treated with the SpineJack system and 160 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients treated with SpineJack system | – | Procedure: SpineJack systemSpineJack system procedure |
| Patients treated with vertebral augmentation | – | Procedure: Balloon kyphoplasty, Procedure: VertebroplastyVertebral augmentation procedures may include either balloon kyphoplasty (BKP) or vertebroplasty (VP). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All eligible patients that meet inclusion criteria.
Key inclusion criteria (4 listed)
- 18 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpineJack systemFor use in the reduction of painful osteoporotic vertebral compression fractures. | Procedure or surgery | Patients treated with SpineJack system |
| Balloon kyphoplastyTreatment of osteoporotic vertebral compression fractures. | Procedure or surgery | Patients treated with vertebral augmentation |
| VertebroplastyTreatment of osteoporotic vertebral compression fractures. | Procedure or surgery | Patients treated with vertebral augmentation |
Primary outcome
Back pain
Time frame: 12 months post-procedure
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).
Radiological outcomes
Time frame: Immeditely post-procedure
Vertebral body height restoration
Radiological outcomes
Time frame: Immediately post-procedure
Adjacent level fractures
Adverse events
Time frame: 12 months post-procedure
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
Quality of life indices - Roland Morris Disability Questionnaire (RMDQ)
Time frame: 12 months post-procedure
24-item self-report questionnaire used in patients with mild to moderate disability due to acute, sub-acute or chronic low back pain
Patient-Reported Outcomes Measurement Information System (PROMIS Global-10)
Time frame: 12 months post-procedure
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporotic Vertebral Compression Fractures, run by Stryker Instruments at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Back pain (time frame: 12 months post-procedure). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.