Osteoporotic Vertebral Compression FracturesNCT07884149
Impact of Diabetes on Patients With Osteoporotic Vertebral Compression Fractures After Vertebral Augmentation
An observational study of Osteoporotic Vertebral Compression Fractures, run by The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine at 1 site in China.
Trial summary
Osteoporotic vertebral compression fractures are common and painful, especially in older adults. A minimally invasive surgery called vertebral augmentation is often used to relieve pain and stabilize the spine. Diabetes is also very common in these patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoporotic Vertebral Compression Fractures
- What is being tested?
- Percutaneous Vertebroplasty (PVP) and Percutaneous Kyphoplasty (PKP)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 30 Sep 2026
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Adults ≥50 years with OVCF treated by PVP/PKP, complete data, and ≥2-year follow-up. Three groups: 1. Non-DM 2. DM with HbA1c <7.0% 3. DM with HbA1c ≥7.0% Target: 360 patients (120/group), 1:1:1 matched for age, sex, BMD T-score, and fracture segment. Key exclusions: Multi-segment fracture, prior same-level spine surgery, pathological fracture, spinal infection, severe comorbidities, and inability to complete follow-up.
Who may be able to join
- Imaging-confirmed osteoporotic vertebral compression fracture (OVCF) with corresponding clinical symptoms and signs.
- Treated with percutaneous vertebroplasty (PVP) or percutaneous kyphoplasty (PKP).
- Age ≥ 50 years at the time of surgery.
- Complete preoperative and postoperative clinical and imaging data available.
- Postoperative follow-up of at least 2 years.
Who cannot join
- Multi-segment vertebral fractures (≥ 3 segments).
- Previous same-segment spinal surgery.
- Pathological fracture.
- Spinal infection.
- Secondary hypertension.
- Severe impairment of cardiac, pulmonary, hepatic, or renal function.
Show all 12Show fewer
- Diseases of the gonads, adrenal glands, parathyroid glands, thyroid gland, or pituitary gland.
- History of immunodeficiency disease (e.g., HIV), cancer or malignant tumor, autoimmune disease, or severe cardiovascular/cerebrovascular disease.
- Other diseases that may significantly reduce life expectancy.
- Participation in any drug clinical trial within 6 months before screening.
- Clear psychiatric history or cognitive impairment that prevents cooperation with follow-up and efficacy evaluation.
- Any condition that the investigator judges unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guanazhou University of Traditional Chinese Mledicine, Guangzhou, Guangdong 510405
Guangzhou, Guangdong, 510405
About this study
Official title: Long-term Impact of Diabetes on Postoperative Outcomes and Risk of Refracture in Patients With Osteoporotic Vertebral Compression Fractures Undergoing Percutaneous Vertebral Augmentation: A Retrospective Cohort Study
Osteoporotic vertebral compression fractures are common and painful, especially in older adults. A minimally invasive surgery called vertebral augmentation is often used to relieve pain and stabilize the spine. Diabetes is also very common in these patients. However, it is unclear if having diabetes, especially with poor blood sugar control, makes it harder for patients to recover after this surgery.
This is a retrospective study. The investigators will review the medical records of patients who had this spine surgery at the study hospital between 2022 and 2024. The investigators will look at patients with and without diabetes. The investigators will compare their pain levels, physical function, and whether they experienced new fractures in the two years after surgery. The investigators will use standard statistical methods to analyze this data. No new treatments or tests will be given to patients; the investigators are only looking at past medical records. Patient privacy will be strictly protected.
This study will help doctors understand how diabetes affects recovery after spine surgery. The results may help guide better blood sugar management and bone health treatments for future patients with diabetes and spinal fractures.
- Being tested
- Percutaneous Vertebroplasty (PVP), Percutaneous Kyphoplasty (PKP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Vertebroplasty (PVP)Procedure or surgery
This is a retrospective cohort study with no experimental intervention assigned. The study observes patients with osteoporotic vertebral compression fractures (OVCF) who underwent standard percutaneous vertebroplasty (PVP) as part of routine clinical care prior to study enrollment. Surgical indications, techniques, and postoperative management (including glycemic control and anti-osteoporosis treatment) were determined by treating physicians in real-world practice and were not controlled by this study. Patients are retrospectively grouped by pre-existing diabetes status and preoperative HbA1c levels (Non-DM, DM with HbA1c <7.0%, and DM with HbA1c ≥7.0%) to evaluate long-term outcomes and refracture risk.
Percutaneous Kyphoplasty (PKP)Procedure or surgery
This is a retrospective cohort study with no experimental intervention assigned. The study observes patients with osteoporotic vertebral compression fractures (OVCF) who underwent standard percutaneous kyphoplasty (PKP) as part of routine clinical care prior to study enrollment. PKP involves balloon inflation to restore vertebral height before bone cement injection. Surgical indications, techniques, and postoperative management (including glycemic control and anti-osteoporosis treatment) were determined by treating physicians in real-world practice and were not controlled by this study. Patients are retrospectively grouped by pre-existing diabetes status and preoperative HbA1c levels (Non-DM, DM with HbA1c <7.0%, and DM with HbA1c ≥7.0%) to evaluate long-term outcomes and refracture risk.
| Study group | Role | What they receive |
|---|---|---|
| Non-Diabetic Control Group (Non-DM) | This group includes patients aged ≥50 years with osteoporotic vertebral compression fracture (OVCF) who underwent percutaneous vertebroplasty (PVP) or percutaneous kyphoplasty (PKP). Patients had no documented history of diabetes mellitus and, if available, normal preoperative HbA1c levels. The Non-DM group serves as the reference group for comparing postoperative pain relief, functional recovery, bone cement leakage, new vertebral fracture, adjacent vertebral refracture, imaging parameters, and reoperation rate. It represents the baseline outcome profile in patients without diabetes. Each group is targeted to include approximately 120 patients, with 1:1:1 propensity score matching on age, sex, bone mineral density T-score, and fracture segment. Receives: Procedure: Percutaneous Vertebroplasty (PVP); Procedure: Percutaneous Kyphoplasty (PKP) | |
| Well-Controlled Diabetes Group (DM-Good) | This group includes patients with OVCF treated by PVP or PKP who have a documented history of diabetes mellitus and a preoperative HbA1c level below 7.0%. It represents diabetic patients whose blood glucose is adequately controlled before surgery. The main purpose of this group is to determine whether well-controlled diabetes still increases the risk of poor outcomes after vertebral augmentation. If outcomes in this group are similar to the Non-DM group, glycemic control may substantially reduce diabetes-related risk. If outcomes remain worse, diabetes itself may still adversely affect bone quality, healing, or refracture risk. Diabetes duration, glucose-lowering medications, diabetic complications, and postoperative anti-osteoporosis treatment will be recorded. This group will be matched 1:1:1 with the other two groups and compared with both the Non-DM and DM-Poor groups. Receives: Procedure: Percutaneous Vertebroplasty (PVP); Procedure: Percutaneous Kyphoplasty (PKP) | |
| Poorly Controlled Diabetes Group (DM-Poor) | This group includes patients with OVCF treated by PVP or PKP who have a documented history of diabetes mellitus and a preoperative HbA1c level of 7.0% or higher. It represents diabetic patients with suboptimal glycemic control and a likely higher metabolic burden. This group is central to the primary hypothesis of the study: that poorly controlled diabetes is an independent risk factor for symptomatic adjacent vertebral refracture, worse pain relief, delayed functional recovery, higher bone cement leakage, increased new vertebral fracture, poorer imaging recovery, and higher reoperation rate. The same clinical, surgical, imaging, and follow-up variables will be collected as in the other groups. This group will also be matched 1:1:1 for age, sex, bone mineral density T-score, and fracture segment and compared with the Non-DM and DM-Good groups to isolate the impact of glycemic control status on long-term outcomes after PVP/PKP. Receives: Procedure: Percutaneous Vertebroplasty (PVP); Procedure: Percutaneous Kyphoplasty (PKP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Symptomatic Adjacent Vertebral Refracture within 2 Years after surgery
The primary outcome is the incidence of symptomatic adjacent vertebral refracture occurring within 2 years following percutaneous vertebroplasty (PVP) or percutaneous kyphoplasty (PKP). A symptomatic adjacent vertebral refracture is defined as a new osteoporotic vertebral compression fracture (OVCF) in a vertebral body immediately adjacent to the previously treated level, confirmed by imaging (X-ray, CT, or MRI) and accompanied by clinical symptoms (e.g., new or worsening back pain). The incidence rate will be compared among three groups: non-diabetic patients (Non-DM), diabetic patients with good glycemic control (HbA1c < 7.0%), and diabetic patients with poor glycemic control (HbA1c ≥ 7.0%). This outcome will determine whether diabetes mellitus, particularly poor glycemic control, is an independent risk factor for adjacent refracture after PVP/PKP.
Measured: Within 2 years after the initial percutaneous vertebral augmentation surgery (PVP/PKP).
Secondary outcomes (9)
Change in Visual Analogue Scale (VAS) Score for Back Pain after Percutaneous Vertebral Augmentation
The VAS is a 0-10 scale (0 = no pain, 10 = worst pain). Back pain VAS will be assessed preoperatively and at 1 week, 3 months, 1 year, and 2 years postoperatively. Changes from baseline and between-group differences among the Non-DM, DM-Good, and DM-Poor groups will be compared to evaluate postoperative pain relief after PVP/PKP.
Measured: Preoperative; 1 week, 3 months, 1 year, and 2 years postoperatively.
Change in Visual Analogue Scale (VAS) Score for Lower Limb Pain after Percutaneous Vertebral Augmentation
Lower limb pain VAS will be measured using the same 0-10 scale. Scores will be recorded preoperatively and at 1 week, 3 months, 1 year, and 2 years after surgery. Changes from baseline and differences among the three groups will be analyzed as a secondary indicator of pain relief.
Measured: Preoperative; 1 week, 3 months, 1 year, and 2 years postoperatively.
Change in Oswestry Disability Index (ODI) Score after Percutaneous Vertebral Augmentation
The ODI is a validated measure of lumbar functional disability, ranging from 0% to 100%, with higher scores indicating greater disability. ODI will be assessed preoperatively and at 1 week, 3 months, 1 year, and 2 years postoperatively. Changes from baseline and between-group differences will be compared to evaluate functional recovery.
Measured: Preoperative; 1 week, 3 months, 1 year, and 2 years postoperatively.
Bone Cement Leakage Rate after Percutaneous Vertebral Augmentation
Bone cement leakage will be assessed by intraoperative fluoroscopy and postoperative imaging. The presence, location, and type of leakage (e.g., spinal canal, intervertebral disc, paravertebral veins, or soft tissue) will be recorded. The leakage rate will be compared among the Non-DM, DM-Good, and DM-Poor groups.
Measured: During surgery and up to 2 years postoperatively.
Cumulative Incidence of New Vertebral Fractures (Regardless of Adjacency) after surgery
New vertebral fractures include any new osteoporotic vertebral compression fracture in a vertebral body other than the initially treated level, regardless of whether it is adjacent or non-adjacent. Diagnosis will be confirmed by imaging (X-ray, CT, or MRI), with or without symptoms. The cumulative incidence within 2 years will be compared among the three groups.
Measured: Within 2 years after surgery.
Local Kyphotic Cobb Angle after Percutaneous Vertebral Augmentation
The local kyphotic Cobb angle of the treated segment will be measured on lateral radiographs or CT. Measurements will be taken preoperatively, 1 week postoperatively, and at the last follow-up. Changes from baseline and between-group differences will be analyzed to assess sagittal alignment and deformity correction.
Measured: Preoperative, postoperative 1 week, and last follow-up (up to 2 years).
Anterior Vertebral Height Ratio Maintenance Rate after Percutaneous Vertebral Augmentation
The anterior vertebral height ratio will be calculated as the anterior height of the treated vertebral body divided by its estimated normal height. Measurements will be performed preoperatively, 1 week postoperatively, and at the last follow-up. The maintenance rate will be compared among groups to evaluate vertebral height preservation.
Measured: Preoperative, postoperative 1 week, and last follow-up (up to 2 years).
Reoperation Rate after Percutaneous Vertebral Augmentation
Reoperation is defined as any secondary surgery at the treated level or adjacent levels due to complications, symptomatic refracture, cement displacement, neurological deterioration, or other procedure-related causes. The reoperation rate within 2 years will be compared among the three groups
Measured: Within 2 years after the initial PVP/PKP surgery.
Safety Complications after Percutaneous Vertebral Augmentation
Safety complications include procedure-related or postoperative adverse events such as infection, nerve injury, cement embolism, pulmonary embolism, deep vein thrombosis, and other major complications. All events will be recorded, and the incidence will be compared among the Non-DM, DM-Good, and DM-Poor groups.
Measured: Within 2 years after the initial PVP/PKP surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Sep 2024
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongping Wang, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884149
- Sponsor's protocol ID
- DWang-ProjectB
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 23 Oct 2026
- 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 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Impact of Diabetes on Postoperative Outcomes and Risk of Refracture in Patients With Osteoporotic Vertebral Compression Fractures Undergoing Percutaneous Vertebral Augmentation: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07884149
- Acronym / sponsor ID
- DWang-ProjectB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- The First Affiliated Hospital, Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 20 Oct 2026 (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.
Osteoporotic vertebral compression fractures are common and painful, especially in older adults. A minimally invasive surgery called vertebral augmentation is often used to relieve pain and stabilize the spine. Diabetes is also very common in these patients. However, it is unclear if having diabetes, especially with poor blood sugar control, makes it harder for patients to recover after this surgery.
This is a retrospective study. The investigators will review the medical records of patients who had this spine surgery at the study hospital between 2022 and 2024. The investigators will look at patients with and without diabetes. The investigators will compare their pain levels, physical function, and whether they experienced new fractures in the two years after surgery. The investigators will use standard statistical methods to analyze this data. No new treatments or tests will be given to patients; the investigators are only looking at past medical records. Patient privacy will be strictly protected.
This study will help doctors understand how diabetes affects recovery after spine surgery. The results may help guide better blood sugar management and bone health treatments for future patients with diabetes and spinal fractures.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-Diabetic Control Group (Non-DM) | – | Procedure: Percutaneous Vertebroplasty (PVP), Procedure: Percutaneous Kyphoplasty (PKP)This group includes patients aged ≥50 years with osteoporotic vertebral compression fracture (OVCF) who underwent percutaneous vertebroplasty (PVP) or percutaneous kyphoplasty (PKP). Patients had no documented history of diabetes mellitus and, if available, normal preoperative HbA1c levels. The Non-DM group serves as the reference group for comparing postoperative pain relief, functional recovery, bone cement leakage, new vertebral fracture, adjacent vertebral refracture, imaging parameters, and reoperation rate. It represents the baseline outcome profile in patients without diabetes. Each group is targeted to include approximately 120 patients, with 1:1:1 propensity score matching on age, sex, bone mineral density T-score, and fracture segment. |
| Well-Controlled Diabetes Group (DM-Good) | – | Procedure: Percutaneous Vertebroplasty (PVP), Procedure: Percutaneous Kyphoplasty (PKP)This group includes patients with OVCF treated by PVP or PKP who have a documented history of diabetes mellitus and a preoperative HbA1c level below 7.0%. It represents diabetic patients whose blood glucose is adequately controlled before surgery. The main purpose of this group is to determine whether well-controlled diabetes still increases the risk of poor outcomes after vertebral augmentation. If outcomes in this group are similar to the Non-DM group, glycemic control may substantially reduce diabetes-related risk. If outcomes remain worse, diabetes itself may still adversely affect bone quality, healing, or refracture risk. Diabetes duration, glucose-lowering medications, diabetic complications, and postoperative anti-osteoporosis treatment will be recorded. This group will be matched 1:1:1 with the other two groups and compared with both the Non-DM and DM-Poor groups. |
| Poorly Controlled Diabetes Group (DM-Poor) | – | Procedure: Percutaneous Vertebroplasty (PVP), Procedure: Percutaneous Kyphoplasty (PKP)This group includes patients with OVCF treated by PVP or PKP who have a documented history of diabetes mellitus and a preoperative HbA1c level of 7.0% or higher. It represents diabetic patients with suboptimal glycemic control and a likely higher metabolic burden. This group is central to the primary hypothesis of the study: that poorly controlled diabetes is an independent risk factor for symptomatic adjacent vertebral refracture, worse pain relief, delayed functional recovery, higher bone cement leakage, increased new vertebral fracture, poorer imaging recovery, and higher reoperation rate. The same clinical, surgical, imaging, and follow-up variables will be collected as in the other groups. This group will also be matched 1:1:1 for age, sex, bone mineral density T-score, and fracture segment and compared with the Non-DM and DM-Good groups to isolate the impact of glycemic control status on long-term outcomes after PVP/PKP. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Adults ≥50 years with OVCF treated by PVP/PKP, complete data, and ≥2-year follow-up. Three groups: 1. Non-DM 2. DM with HbA1c <7.0% 3. DM with HbA1c ≥7.0% Target: 360 patients (120/group), 1:1:1 matched for age, sex, BMD T-score, and fracture segment. Key exclusions: Multi-segment fracture, prior same-level spine surgery, pathological fracture, spinal infection, severe comorbidities, and inability to complete follow-up.
Key inclusion criteria (5 listed)
- Imaging-confirmed osteoporotic vertebral compression fracture (OVCF) with corresponding clinical symptoms and signs.
- Treated with percutaneous vertebroplasty (PVP) or percutaneous kyphoplasty (PKP).
- Age ≥ 50 years at the time of surgery.
- Complete preoperative and postoperative clinical and imaging data available.
- Postoperative follow-up of at least 2 years.
Key exclusion criteria (12 listed)
- Multi-segment vertebral fractures (≥ 3 segments).
- Previous same-segment spinal surgery.
- Pathological fracture.
- Spinal infection.
- Secondary hypertension.
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 Vertebroplasty (PVP)This is a retrospective cohort study with no experimental intervention assigned. The study observes patients with osteoporotic vertebral compression fractures (OVCF) who underwent standard percutaneous vertebroplasty (PVP) as part of routine clinical care prior to study enrollment. Surgical indications, techniques, and postoperative management (including glycemic control and anti-osteoporosis treatment) were determined by treating physicians in real-world practice and were not controlled by this study. Patients are retrospectively grouped by pre-existing diabetes status and preoperative HbA1c levels (Non-DM, DM with HbA1c <7.0%, and DM with HbA1c ≥7.0%) to evaluate long-term outcomes and refracture risk. | Procedure or surgery | Non-Diabetic Control Group (Non-DM), Poorly Controlled Diabetes Group (DM-Poor), Well-Controlled Diabetes Group (DM-Good) |
| Percutaneous Kyphoplasty (PKP)This is a retrospective cohort study with no experimental intervention assigned. The study observes patients with osteoporotic vertebral compression fractures (OVCF) who underwent standard percutaneous kyphoplasty (PKP) as part of routine clinical care prior to study enrollment. PKP involves balloon inflation to restore vertebral height before bone cement injection. Surgical indications, techniques, and postoperative management (including glycemic control and anti-osteoporosis treatment) were determined by treating physicians in real-world practice and were not controlled by this study. Patients are retrospectively grouped by pre-existing diabetes status and preoperative HbA1c levels (Non-DM, DM with HbA1c <7.0%, and DM with HbA1c ≥7.0%) to evaluate long-term outcomes and refracture risk. | Procedure or surgery | Non-Diabetic Control Group (Non-DM), Poorly Controlled Diabetes Group (DM-Poor), Well-Controlled Diabetes Group (DM-Good) |
Primary outcome
Incidence of Symptomatic Adjacent Vertebral Refracture within 2 Years after surgery
Time frame: Within 2 years after the initial percutaneous vertebral augmentation surgery (PVP/PKP).
The primary outcome is the incidence of symptomatic adjacent vertebral refracture occurring within 2 years following percutaneous vertebroplasty (PVP) or percutaneous kyphoplasty (PKP). A symptomatic adjacent vertebral refracture is defined as a new osteoporotic vertebral compression fracture (OVCF) in a vertebral body immediately adjacent to the previously treated level, confirmed by imaging (X-ray, CT, or MRI) and accompanied by clinical symptoms (e.g., new or worsening back pain). The incidence rate will be compared among three groups: non-diabetic patients (Non-DM), diabetic patients with good glycemic control (HbA1c < 7.0%), and diabetic patients with poor glycemic control (HbA1c ≥ 7.0%). This outcome will determine whether diabetes mellitus, particularly poor glycemic control, is an independent risk factor for adjacent refracture after PVP/PKP.
9 secondary outcomes
Change in Visual Analogue Scale (VAS) Score for Back Pain after Percutaneous Vertebral Augmentation
Time frame: Preoperative; 1 week, 3 months, 1 year, and 2 years postoperatively.
Change in Visual Analogue Scale (VAS) Score for Lower Limb Pain after Percutaneous Vertebral Augmentation
Time frame: Preoperative; 1 week, 3 months, 1 year, and 2 years postoperatively.
Change in Oswestry Disability Index (ODI) Score after Percutaneous Vertebral Augmentation
Time frame: Preoperative; 1 week, 3 months, 1 year, and 2 years postoperatively.
Bone Cement Leakage Rate after Percutaneous Vertebral Augmentation
Time frame: During surgery and up to 2 years postoperatively.
Cumulative Incidence of New Vertebral Fractures (Regardless of Adjacency) after surgery
Time frame: Within 2 years after surgery.
Local Kyphotic Cobb Angle after Percutaneous Vertebral Augmentation
Time frame: Preoperative, postoperative 1 week, and last follow-up (up to 2 years).
Anterior Vertebral Height Ratio Maintenance Rate after Percutaneous Vertebral Augmentation
Time frame: Preoperative, postoperative 1 week, and last follow-up (up to 2 years).
Reoperation Rate after Percutaneous Vertebral Augmentation
Time frame: Within 2 years after the initial PVP/PKP surgery.
Safety Complications after Percutaneous Vertebral Augmentation
Time frame: Within 2 years after the initial PVP/PKP surgery.
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 23 Oct 2026.
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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.
1 site 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 The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine 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 5 inclusion and 12 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 23 Oct 2026. 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?
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?
Incidence of Symptomatic Adjacent Vertebral Refracture within 2 Years after surgery (time frame: Within 2 years after the initial percutaneous vertebral augmentation surgery (PVP/PKP).). 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 2026.