Osteoporotic Fracture of VertebraNCT05519332
Percutaneous Vertebral-disc Plasty for Thoracolumbar Very Severe Osteoporotic Vertebral Compression Fractures
A study testing percutaneous vertebral-disc plasty in people with Osteoporotic Fracture of Vertebra, run by Jiawei Jiang at 1 site in China.
Trial summary
Purpose: To compare the clinical outcomes and radiological parameters of patients undergoing percutaneous vertebroplasty (PVP) versus those undergoing percutaneous vertebral-disc plasty (PVDP) for back pain, segmental instability, and kyphosis due to thoracolumbar very severe osteoporotic vertebral compression… Read more about this study
- Who is it for?
- Ages 58 to 84 years
- Conditions the study is for
- Osteoporotic Fracture of Vertebra
- What is being tested?
- percutaneous vertebral-disc plasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to Dec 2025
- Phase
- Interventional
- 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 58 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- bone mineral density T scores <-2.5;
- compression of the vertebral anterior column greater than two-thirds of their original height;
- Kyphosis with LKA greater than 20°;
- the accordion phenomenon: the different angles of a supine CT scan and a lateral standing X-ray measurement;
- upper or lower vertebral endplate fracture;
- the involved vertebral body was intact;
- Elderly patients with a history of major illness (such as cardiovascular disease, cancer or active malignancy) and were intolerant of the traditional open surgery.
Who cannot join
- Pathological vertebral fractures caused by spinal tumors, spinal tuberculosis, and spinal infection and so on;
- Patients with symptoms of nerve roots or spinal cord compression;
- Patients with a previous history of spinal fusion;
- A history of abnormal bleeding or coagulation disorder dysfunction.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Affiliated 2 Hospital of Nantong University
Nantong, Jiangsu, 0513
Jiawei Jiang, Dr, 18862802782, 18862802782@163.com
Hongqing Xu, Dr
About this study
Purpose: To compare the clinical outcomes and radiological parameters of patients undergoing percutaneous vertebroplasty (PVP) versus those undergoing percutaneous vertebral-disc plasty (PVDP) for back pain, segmental instability, and kyphosis due to thoracolumbar very severe osteoporotic vertebral compression fractures (vsOVCFs).
This prospective study included elderly patients with thoracolumbar vsOVCFs. All the patients were randomly allocated into the PVP group (who underwent conventional PVP) and the PVDP group (who underwent PVP combined percutaneous cement discoplasty). The visual analogue scale (VAS), Oswestry Disability Index (ODI), local kyphosis angle, and disc height were recorded preoperatively and postoperatively.
Read the detailed description
Patients diagnosed with thoracolumbar vsOVCFs in hospital and undergoing minimally invasive treatment from November 2019 to March 2021 were enrolled for the study. They were randomly allocated into two groups (based on random numbers generated by www. randomizer.org), namely PVP group and PVDP group.
Operative technique：In PVDP group, PVP and PCD both used a unilateral transpedicular approach into the vertebrae and disc. . Under general anesthesia, the patient was turned over to a prone position, and the deformity is reduced with a slight closed manipulative. Firstly, under fluoroscopic O-arm guidance, the puncture site was localized into the junction made by the transverse process and the superior articular process and entered the target area according to the puncture angle and depth measured before the operation. Secondly, the other puncture cannula was inserted into the intervertebral disc space adjacent to the ruptured endplate through the transpedicular access, and the target area was the middle of the intervertebral space. Thin-cut CT images were obtained intraoperatively by the O-arm fluoroscopy to confirm puncture needle placement location. Third, the bone cement was injected into the vertebrae and the intervertebral disc space, meanwhile, the cannula was also needed to move back to the vertebrae, and the bone cement in the vertebrae could connect the intervertebral disc space and the vertebrae to form a whole. Finally, the PVP group and the adjacent vertebrae performed by prophylactic vertebroplasty used bilateral pedicle puncture, under the guidance of the O-arm, two puncture needles were percutaneously inserted into the vertebrae, reaching about the middle of the vertebrae. Then, cement was slowly injected into the vertebral body, once cement leakage into the spinal canal or veins was detected, the injection was stopped.
The investigators measured radiological parameters including the local kyphotic angle (LKA), disc height anterior (DHA), and disc height posterior (DHP) from lateral plain radiographs preoperatively and at 1 day and final follow-up after surgery. The visual analog score (VAS) was used to assess the preoperative and postoperative back pain relief. The Oswestry Disability Index (ODI) was used to assess the quality of life and was recorded preoperatively, postoperatively, and final follow-up.
- Conditions
- Osteoporotic Fracture of Vertebra
- Being tested
- percutaneous vertebral-disc plasty
- Keywords
- percutaneous vertebroplasty, percutaneous cement discoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous vertebral-disc plastyProcedure or surgery
percutaneous vertebroplasty combined percutaneous cement discoplasty
| Study group | Role | What they receive |
|---|---|---|
| PVDP group | Experimental | Patients underwent percutaneous vertebral-disc plasty Receives: Procedure: percutaneous vertebral-disc plasty |
| PVP group | No intervention | Patients underwent conventional percutaneous vertebroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline visual analogue scale
Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0 to 100. A higher score indicates greater pain intensity. Based on the distribution of pain Visual Analogue Scale scores in post-surgical patients who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain Visual Analogue Scale have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Measured: One day before operation, one day after operation and 1year.
Change from Baseline Oswestry Disability Index
The ODI assesses ten aspects of daily functions viz. pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling. An ODI of 0-20% indicates minimal disability; the patients can cope with most living activities and usually no treatment is indicated, apart from advice on lifting, sitting and exercise. An ODI of 21-40% indicates moderate disability; the patients experience more pain and difficulty with sitting, lifting and standing; travel and social life are more difficult and they may be disabled from work; personal care, sexual activity and sleeping are not grossly affected. An ODI of 41-60% indicates severe disability; pain remains the main problem in this group of patients; the activities of daily living are affected. Patients with an ODI of 61-80% are severely crippled in function with back pain impinging on all aspects of the patient's life. Finally, an ODI of 81-100% indicates that the patients are bed-bound.
Measured: One day before operation, one day after operation and 1year.
Change from Baseline the local kyphotic angle
The local kyphotic angle (LKA) was calculated by a measurement called Cobb's method, which measured the angle between the superior endplate of the upper vertebrae and the inferior endplate of the lower vertebrae. Use this to assess the degree of local kyphosis of the spine.
Measured: One day before operation, one day after operation and 1year.
Secondary outcomes (2)
Change from Baseline the disc height anterior
Disc height anterior(DHA) was measured from the anterior points of the disc on lateral plain radiographs. It is used to assess the degree of height loss at the anterior border of the intervertebral space.
Measured: One day before operation, one day after operation and 1year.
Change from Baseline the disc height posterior
Disc height posterior (DHP) was measured from the posterior points of the disc on lateral plain radiographs. It is used to assess the degree of height loss at the posterior border of the intervertebral space.
Measured: One day before operation, one day after operation and 1year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 Mar 2020
- Primary completionJul 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporotic Fracture of VertebraStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiawei Jiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiawei Jiang, Affiliated 2 Hospital of Nantong University
- Investigators
- Guanhua Xu, Dr, Principal investigator, Affiliated 2 Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519332
- Sponsor's protocol ID
- JJiang
- Status last verified
- Apr 2025
- First submitted
- 24 Aug 2022
- Last updated
- 4 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Vertebral-disc Plasty for Thoracolumbar Very Severe Osteoporotic Vertebral Compression Fractures
- ClinicalTrials.gov ID
- NCT05519332
- Acronym / sponsor ID
- JJiang
- Conditions
- Osteoporotic Fracture of Vertebra
- Keywords
- percutaneous vertebroplasty, percutaneous cement discoplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jiawei JiangUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 Aug 2022 (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.
Purpose: To compare the clinical outcomes and radiological parameters of patients undergoing percutaneous vertebroplasty (PVP) versus those undergoing percutaneous vertebral-disc plasty (PVDP) for back pain, segmental instability, and kyphosis due to thoracolumbar very severe osteoporotic vertebral compression fractures (vsOVCFs).
This prospective study included elderly patients with thoracolumbar vsOVCFs. All the patients were randomly allocated into the PVP group (who underwent conventional PVP) and the PVDP group (who underwent PVP combined percutaneous cement discoplasty). The visual analogue scale (VAS), Oswestry Disability Index (ODI), local kyphosis angle, and disc height were recorded preoperatively and postoperatively.
Detailed description
Patients diagnosed with thoracolumbar vsOVCFs in hospital and undergoing minimally invasive treatment from November 2019 to March 2021 were enrolled for the study. They were randomly allocated into two groups (based on random numbers generated by www. randomizer.org), namely PVP group and PVDP group.
Operative technique：In PVDP group, PVP and PCD both used a unilateral transpedicular approach into the vertebrae and disc. . Under general anesthesia, the patient was turned over to a prone position, and the deformity is reduced with a slight closed manipulative. Firstly, under fluoroscopic O-arm guidance, the puncture site was localized into the junction made by the transverse process and the superior articular process and entered the target area according to the puncture angle and depth measured before the operation. Secondly, the other puncture cannula was inserted into the intervertebral disc space adjacent to the ruptured endplate through the transpedicular access, and the target area was the middle of the intervertebral space. Thin-cut CT images were obtained intraoperatively by the O-arm fluoroscopy to confirm puncture needle placement location. Third, the bone cement was injected into the vertebrae and the intervertebral disc space, meanwhile, the cannula was also needed to move back to the vertebrae, and the bone cement in the vertebrae could connect the intervertebral disc space and the vertebrae to form a whole. Finally, the PVP group and the adjacent vertebrae performed by prophylactic vertebroplasty used bilateral pedicle puncture, under the guidance of the O-arm, two puncture needles were percutaneously inserted into the vertebrae, reaching about the middle of the vertebrae. Then, cement was slowly injected into the vertebral body, once cement leakage into the spinal canal or veins was detected, the injection was stopped.
The investigators measured radiological parameters including the local kyphotic angle (LKA), disc height anterior (DHA), and disc height posterior (DHP) from lateral plain radiographs preoperatively and at 1 day and final follow-up after surgery. The visual analog score (VAS) was used to assess the preoperative and postoperative back pain relief. The Oswestry Disability Index (ODI) was used to assess the quality of life and was recorded preoperatively, postoperatively, and final follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVDP group | Experimental | Procedure: percutaneous vertebral-disc plastyPatients underwent percutaneous vertebral-disc plasty |
| PVP group | No intervention | –Patients underwent conventional percutaneous vertebroplasty |
Who may qualify
- Ages
- 58 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- bone mineral density T scores <-2.5;
- compression of the vertebral anterior column greater than two-thirds of their original height;
- Kyphosis with LKA greater than 20°;
- the accordion phenomenon: the different angles of a supine CT scan and a lateral standing X-ray measurement;
- upper or lower vertebral endplate fracture;
Key exclusion criteria (4 listed)
- Pathological vertebral fractures caused by spinal tumors, spinal tuberculosis, and spinal infection and so on;
- Patients with symptoms of nerve roots or spinal cord compression;
- Patients with a previous history of spinal fusion;
- A history of abnormal bleeding or coagulation disorder dysfunction.
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 |
|---|---|---|
| percutaneous vertebral-disc plastypercutaneous vertebroplasty combined percutaneous cement discoplasty | Procedure or surgery | PVDP group |
Primary outcome
Change from Baseline visual analogue scale
Time frame: One day before operation, one day after operation and 1year.
Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0 to 100. A higher score indicates greater pain intensity. Based on the distribution of pain Visual Analogue Scale scores in post-surgical patients who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain Visual Analogue Scale have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Change from Baseline Oswestry Disability Index
Time frame: One day before operation, one day after operation and 1year.
The ODI assesses ten aspects of daily functions viz. pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling. An ODI of 0-20% indicates minimal disability; the patients can cope with most living activities and usually no treatment is indicated, apart from advice on lifting, sitting and exercise. An ODI of 21-40% indicates moderate disability; the patients experience more pain and difficulty with sitting, lifting and standing; travel and social life are more difficult and they may be disabled from work; personal care, sexual activity and sleeping are not grossly affected. An ODI of 41-60% indicates severe disability; pain remains the main problem in this group of patients; the activities of daily living are affected. Patients with an ODI of 61-80% are severely crippled in function with back pain impinging on all aspects of the patient's life. Finally, an ODI of 81-100% indicates that the patients are bed-bound.
Change from Baseline the local kyphotic angle
Time frame: One day before operation, one day after operation and 1year.
The local kyphotic angle (LKA) was calculated by a measurement called Cobb's method, which measured the angle between the superior endplate of the upper vertebrae and the inferior endplate of the lower vertebrae. Use this to assess the degree of local kyphosis of the spine.
2 secondary outcomes
Change from Baseline the disc height anterior
Time frame: One day before operation, one day after operation and 1year.
Change from Baseline the disc height posterior
Time frame: One day before operation, one day after operation and 1year.
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 4 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Guanhua Xu, Dr principal investigator
Affiliated 2 Hospital of Nantong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing percutaneous vertebral-disc plasty in people with Osteoporotic Fracture of Vertebra, run by Jiawei Jiang at 1 site in China.
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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
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 Jiawei Jiang, Dr (18862802782, 18862802782@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline visual analogue scale (time frame: One day before operation, one day after operation and 1year.). The study lists 3 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 4 Apr 2025.