BKPPhase 1/2NCT06093087
Randomized Controlled Trial of Internal Fixation Reconstruction With Stent Screw in the Treatment of Kummell's Disease
A Phase 1/2 study testing SAIF and BKP in people with BKP and Osteoporotic Vertebral Compression Fracture, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
This study is a multicenter, prospective, double-blind, randomized controlled trial using a parallel two-arm design to investigate whether the postoperative 6-month quality of life, vertebral stability, complication of patients with osteoporotic vertebral compression fractures (Kummell's disease) are better with the… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- BKP, Osteoporotic Vertebral Compression Fracture, Kummell's Disease
- What is being tested?
- SAIF and BKP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 1 Sep 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60 or above, gender not specified.
- Must have one to three vertebral segments with vertebral compression fracture (VCF) located between T5 and L5, attributed to underlying primary or secondary osteoporosis rather than cancer.
- All VCFs must exhibit the following radiographic changes: according to Genant's criteria, acute (≤4 months) decrease in anterior, middle, or posterior vertebral height by at least one grade (20-25% reduction in vertebral height, 10-20% reduction in vertebral area) compared to previous X-ray, CT, or MRI results.
- All VCFs for treatment must occur within four months or less.
- All VCFs for treatment must be technically feasible and clinically suitable for BKP or SAIF surgery.
- Pre-treatment back pain NRS score must be ≥ 7 and ineffective with conservative (non-surgical) treatment.
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- Pre-treatment Oswestry Disability Index must be ≥ 30 (on a scale of 0-100).
- Patient's life expectancy must be ≥ 12 months.
- Must declare willingness to participate in all post-operative follow-ups.
- Must be capable of understanding the risks and benefits of the study and willing to provide written informed consent.
Who cannot join
- Vertebral morphology or fracture morphology unsuitable for balloon kyphoplasty. VCF caused by high-energy trauma.
- Asymptomatic VCF or vertebral bodies amenable to prophylactic treatment.
- VCF at the same site associated with primary bone tumors.
- Back pain caused by reasons other than acute fractures. VCF with an estimated fracture time of more than 4 months, based on clinical assessment (radiological evidence and patient history).
- VCF associated with secondary radiculopathy or neurological compromise.
- VCF requiring spinal surgery other than BKP or SAIF.
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- Spinal cord compression or vertebral canal injury requiring decompression surgery.
- Combined clinical conditions unsuitable for surgery or affecting subsequent long-term data collection or follow-up.
- Allergy to any component during the surgical procedure (e.g., bone cement, contrast agents).
- Concurrent participation in another clinical study.
- Pregnancy during the study or planning to become pregnant.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Internal Fixation Reconstruction With Stent Screw VS Balloon Kyphoplasty in the Treatment of Kummell's Disease: a Double Blinded Randomized Controlled Trial
This study is a multicenter, prospective, double-blind, randomized controlled trial using a parallel two-arm design to investigate whether the postoperative 6-month quality of life, vertebral stability, complication of patients with osteoporotic vertebral compression fractures (Kummell's disease) are better with the use of stent screw internal fixation and percutaneous bone cement reconstruction technique compared to patients undergoing traditional percutaneous balloon kyphoplasty (BKP) for vertebral augmentation
- Conditions
- BKP, Osteoporotic Vertebral Compression Fracture, Kummell's Disease, Stent-screw-assisted Internal Fixation
- Being tested
- SAIF, BKP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAIFProcedure or surgery
The patient was placed in a prone position under general anesthesia. Using a C-arm X-ray machine and a positioning plate for navigation, the target position on the vertebral body was located one the surface of the body. The puncture needle core was withdrawn after puncturing, and a guide needle was inserted. After removing the puncture needle sleeve, a hollow bone cement screw was screwed into the anterior column of the vertebral body through the guide needle. Subsequently, bone cement was injected into the appropriate position through the bone cement screw to restore the vertebral height
BKPProcedure or surgery
The patient was placed in a prone position after general anesthesia. Using a C-arm X-ray machine and a positioning plate for guidance, the target position on the vertebral body was located from the surface of the body. A puncture needle sleeve was inserted into the vertebral body. A PKP balloon was then inserted to perform vertebral restoration. After removing the balloon, an appropriate amount of bone cement was injected to ensure even distribution within the vertebral body. Vertebral height augmentation and restoration will then be achieved.
| Study group | Role | What they receive |
|---|---|---|
| SAIF | Experimental | patients will be treated with kyphoplasty surgery combined with pedicular screw-assisted internal fixation for vertebral augmentation Receives: Procedure: SAIF |
| BKP | Active comparator | patients will be treated with balloon kyphoplasty surgery for vertebral augmentation Receives: Procedure: BKP |
What is being measured
The primary outcome is the main question the study is designed to answer.
ODI score
Each patients were asked to complete the Oswestry Disability Index questionnaire postoperatively during follow up
Measured: ODI score measured 1,3,6 months post surgery during follow up
Secondary outcomes (4)
CT imaging indicators related to vertebral body stability
There are total 5 indicators measured based on CT images: Anterior vertebral height (ant VBH), middle vertebral height (mid VBH), posterior vertebral height (post VBH), vertebral kyphosis angle (VKA), local kyphosis angle (LKA)
Measured: all variables were measured 1,3,6 months post surgery during follow up
SF36 score
SF-36 questionnaire aimed at two different constructs to measure health-related quality of life: the Physical Component and the Mental Component
Measured: measured 1,3,6 months post surgery during follow up
VAS score
The Visual Analogue Scale (VAS) measures pain intensity. 0 indicates no pain and 10 indicates pain as bad as it could possibly be
Measured: measured 1,3,6 months post surgery during follow up
EQ-5D score
The EQ-5D descriptive system measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Measured: measured 1,3,6 months post surgery during follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BKPStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093087
- Sponsor's protocol ID
- LWL_2023
- Status last verified
- Oct 2023
- First submitted
- 19 Oct 2023
- Last updated
- 23 Oct 2023
- 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 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internal Fixation Reconstruction With Stent Screw VS Balloon Kyphoplasty in the Treatment of Kummell's Disease: a Double Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06093087
- Acronym / sponsor ID
- LWL_2023
- Conditions
- BKP, Osteoporotic Vertebral Compression Fracture, Kummell's Disease, Stent-screw-assisted Internal Fixation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 23 Oct 2023 (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 study is a multicenter, prospective, double-blind, randomized controlled trial using a parallel two-arm design to investigate whether the postoperative 6-month quality of life, vertebral stability, complication of patients with osteoporotic vertebral compression fractures (Kummell's disease) are better with the use of stent screw internal fixation and percutaneous bone cement reconstruction technique compared to patients undergoing traditional percutaneous balloon kyphoplasty (BKP) for vertebral augmentation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAIF | Experimental | Procedure: SAIFpatients will be treated with kyphoplasty surgery combined with pedicular screw-assisted internal fixation for vertebral augmentation |
| BKP | Active comparator | Procedure: BKPpatients will be treated with balloon kyphoplasty surgery for vertebral augmentation |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 60 or above, gender not specified.
- Must have one to three vertebral segments with vertebral compression fracture (VCF) located between T5 and L5, attributed to underlying primary or secondary osteoporosis rather than cancer.
- All VCFs must exhibit the following radiographic changes: according to Genant's criteria, acute (≤4 months) decrease in anterior, middle, or posterior vertebral height by at least one grade (20-25% reduction in vertebral height, 10-20% reduction in vertebral area) compared to previous X-ray, CT, or MRI results.
- All VCFs for treatment must occur within four months or less.
- All VCFs for treatment must be technically feasible and clinically suitable for BKP or SAIF surgery.
Key exclusion criteria (11 listed)
- Vertebral morphology or fracture morphology unsuitable for balloon kyphoplasty. VCF caused by high-energy trauma.
- Asymptomatic VCF or vertebral bodies amenable to prophylactic treatment.
- VCF at the same site associated with primary bone tumors.
- Back pain caused by reasons other than acute fractures. VCF with an estimated fracture time of more than 4 months, based on clinical assessment (radiological evidence and patient history).
- VCF associated with secondary radiculopathy or neurological compromise.
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 |
|---|---|---|
| SAIFThe patient was placed in a prone position under general anesthesia. Using a C-arm X-ray machine and a positioning plate for navigation, the target position on the vertebral body was located one the surface of the body. The puncture needle core was withdrawn after puncturing, and a guide needle was inserted. After removing the puncture needle sleeve, a hollow bone cement screw was screwed into the anterior column of the vertebral body through the guide needle. Subsequently, bone cement was injected into the appropriate position through the bone cement screw to restore the vertebral height | Procedure or surgery | SAIF |
| BKPThe patient was placed in a prone position after general anesthesia. Using a C-arm X-ray machine and a positioning plate for guidance, the target position on the vertebral body was located from the surface of the body. A puncture needle sleeve was inserted into the vertebral body. A PKP balloon was then inserted to perform vertebral restoration. After removing the balloon, an appropriate amount of bone cement was injected to ensure even distribution within the vertebral body. Vertebral height augmentation and restoration will then be achieved. | Procedure or surgery | BKP |
Primary outcome
ODI score
Time frame: ODI score measured 1,3,6 months post surgery during follow up
Each patients were asked to complete the Oswestry Disability Index questionnaire postoperatively during follow up
4 secondary outcomes
CT imaging indicators related to vertebral body stability
Time frame: all variables were measured 1,3,6 months post surgery during follow up
SF36 score
Time frame: measured 1,3,6 months post surgery during follow up
VAS score
Time frame: measured 1,3,6 months post surgery during follow up
EQ-5D score
Time frame: measured 1,3,6 months post surgery during follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SAIF and BKP in people with BKP and Osteoporotic Vertebral Compression Fracture, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 10 inclusion and 11 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: opening soon, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wanli Li, MD (+86 13967116021, liwanli@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ODI score (time frame: ODI score measured 1,3,6 months post surgery during follow up). 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 23 Oct 2023.