OsteoporosisNCT05130242
A Retrospective Comparison Between CPS and HC Techniques for Osteoporotic Fractures in the Thoracic or Lumbar Spine
An observational study of Osteoporosis, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Cement-augmented pedicle screws (CPS) and hybrid construct (HC) consisting of pedicle screws and additional hooks are common methods in osteoporotic fracture of the thoracic and lumbar spine. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Cement-augmented Pedicle Screws (CPS) and Hybrid Construct (HC)
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Jan 2021to 21 Jan 2022
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient who underwent surgical treatment with CPS or HC of pedicle screws and hooks for osteoporotic fractures in the thoracic or lumbar spine in our hospital from January 2011 through December 2015
Who may be able to join
- Surgical treatment with CPS or HC of pedicle screws and hooks for osteoporotic fractures in the thoracic or lumbar spine
- Received a minimum of 2-year follow-up
Who cannot join
- T-scores greater than -2.5
- Cancer metastasis
- Chronic osteomyelitis
- Failure to complete the questionnaires or radiographic examinations
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital
Taipei
Shih-Tien Wang, MD, 886-2-28757557 ext. 9, stwang@vghtpe.gov.tw
About this study
Official title: Posterior Instrumentation for Osteoporotic Fractures in the Thoracic or Lumbar Spine: A Retrospective Comparison Between Cement Augmented Pedicle Screws and Hybrid Constructs of Pedicle Screws and Hooks
Cement-augmented pedicle screws (CPS) and hybrid construct (HC) consisting of pedicle screws and additional hooks are common methods in osteoporotic fracture of the thoracic and lumbar spine. No study has compared the surgical results between CPS and HC techniques for treatment of the osteoporotic thoracic and lumbar spine fracture. The aim of the retrospective study was to compare surgical results using CPS or HC for osteoporotic fractures in the thoracic or lumbar spine. Patients who received surgical treatment with CPS or HC for osteoporotic fractures in the thoracic or lumbar spine.
Read the detailed description
Osteoporosis, the most common metabolic bone disease, leads to alteration of bone density that has been shown to compromise the strength of spinal instrumentation. With elderly populations growing, rates of spine surgery performed on osteoporotic patients have increased to treat a variety of conditions. Vertebral fracture is the most common osteoporotic fracture in the elderly, and surgical intervention is sometimes needed for patients who are diagnosed as nonunion, failure of vertebroplasty, and neurologic deficits. Therefore, spine surgeons will increasingly face the challenge of achieving rigid fixation of osteoporotic spines.
Cement-augmented pedicle screws are the most common strategy to maximize pullout strength for fixation of osteoporotic spines. Hybrid constructs, a combination of pedicle screws and hooks, offer an alternative approach to avoid implant failure and increasing construct stability when placing instrumentation in the osteoporotic spine. Biomechanical studies of either cement-augmented pedicle screws or combined pedicle screws and hooks for osteoporotic spine have demonstrated superior results compared to pedicle screws only in terms of improving implant pullout strength. However, few clinical investigation to date has focused on comparing surgical results of the cement-augmented pedicle screws (CPS) and hybrid construct (HC) techniques. The goal of the retrospective cohort study was to compare the surgical outcomes and surgery-, patient- and implant-related complications between the CPS and HC techniques for osteoporotic vertebral fractures in the thoracic or lumbar spine.
- Conditions
- Osteoporosis
- Being tested
- Cement-augmented Pedicle Screws (CPS), Hybrid Construct (HC)
- Keywords
- Thoracolumbar fracture, Cement augmentation, Hook, Pedicle Screw, Hybrid Construct
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cement-augmented Pedicle Screws (CPS)Procedure or surgery
Patients who received surgical treatment with CPS for osteoporotic fractures in the thoracic or lumbar spine
Hybrid Construct (HC)Procedure or surgery
Patients who received surgical treatment with HC consisting of pedicle screws and additional hooks for osteoporotic fractures in the thoracic or lumbar spine
| Study group | Role | What they receive |
|---|---|---|
| Cement-augmented Pedicle Screws (CPS) Group | Not described Receives: Procedure: Cement-augmented Pedicle Screws (CPS) | |
| Hybrid Construct (HC) group | Not described Receives: Procedure: Hybrid Construct (HC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Failure
Implant failure was defined as pull-out or breakage of the implants on plain X-ray film.
Measured: Postoperative 1 year
Kyphotic Angle
Cobb's method was used to measure the regional kyphotic angle
Measured: Preoperative
Kyphotic Angle
Cobb's method was used to measure the regional kyphotic angle
Measured: Postoperative 1 month.
Kyphotic Angle
Cobb's method was used to measure the regional kyphotic angle
Measured: Postoperative 2 months.
Kyphotic Angle
Cobb's method was used to measure the regional kyphotic angle
Measured: Postoperative 3 months.
Kyphotic Angle
Cobb's method was used to measure the regional kyphotic angle
Measured: Postoperative 6 months.
Kyphotic Angle
Cobb's method was used to measure the regional kyphotic angle
Measured: Postoperative 12 months.
Visual Analogue Scale (VAS)
Functional outcomes, Back pain evaluated
Measured: Preoperative
Visual Analogue Scale (VAS)
Functional outcomes, Back pain evaluated
Measured: Postoperative 1 month.
Visual Analogue Scale (VAS)
Functional outcomes, Back pain evaluated
Measured: Postoperative 2 months.
Visual Analogue Scale (VAS)
Functional outcomes, Back pain evaluated
Measured: Postoperative 3 months.
Visual Analogue Scale (VAS)
Functional outcomes, Back pain evaluated
Measured: Postoperative 6 months.
Visual Analogue Scale (VAS)
Functional outcomes, Back pain evaluated
Measured: Postoperative 12 months.
Oswestry Disability Index (ODI)
Functional outcomes, Disability evaluated
Measured: Preoperative
Oswestry Disability Index (ODI)
Functional outcomes, Disability evaluated
Measured: Postoperative 1 month.
Oswestry Disability Index (ODI)
Functional outcomes, Disability evaluated
Measured: Postoperative 2 months.
Oswestry Disability Index (ODI)
Functional outcomes, Disability evaluated
Measured: Postoperative 3 months.
Oswestry Disability Index (ODI)
Functional outcomes, Disability evaluated
Measured: Postoperative 6 months.
Oswestry Disability Index (ODI)
Functional outcomes, Disability evaluated
Measured: Postoperative 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start21 Jan 2021
- Primary completion21 Jan 2022 (estimated)
- Study completion21 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130242
- Sponsor's protocol ID
- 2021-01-030CC
- Status last verified
- Nov 2021
- First submitted
- 19 Oct 2021
- Last updated
- 23 Nov 2021
- 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 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Instrumentation for Osteoporotic Fractures in the Thoracic or Lumbar Spine: A Retrospective Comparison Between Cement Augmented Pedicle Screws and Hybrid Constructs of Pedicle Screws and Hooks
- ClinicalTrials.gov ID
- NCT05130242
- Acronym / sponsor ID
- 2021-01-030CC
- Conditions
- Osteoporosis
- Keywords
- Thoracolumbar fracture, Cement augmentation, Hook, Pedicle Screw, Hybrid Construct
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 21 Jan 2022 (estimated)
- Study completion
- 21 Jan 2022 (estimated)
- First posted
- 23 Nov 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.
Cement-augmented pedicle screws (CPS) and hybrid construct (HC) consisting of pedicle screws and additional hooks are common methods in osteoporotic fracture of the thoracic and lumbar spine. No study has compared the surgical results between CPS and HC techniques for treatment of the osteoporotic thoracic and lumbar spine fracture. The aim of the retrospective study was to compare surgical results using CPS or HC for osteoporotic fractures in the thoracic or lumbar spine. Patients who received surgical treatment with CPS or HC for osteoporotic fractures in the thoracic or lumbar spine.
Detailed description
Osteoporosis, the most common metabolic bone disease, leads to alteration of bone density that has been shown to compromise the strength of spinal instrumentation. With elderly populations growing, rates of spine surgery performed on osteoporotic patients have increased to treat a variety of conditions. Vertebral fracture is the most common osteoporotic fracture in the elderly, and surgical intervention is sometimes needed for patients who are diagnosed as nonunion, failure of vertebroplasty, and neurologic deficits. Therefore, spine surgeons will increasingly face the challenge of achieving rigid fixation of osteoporotic spines.
Cement-augmented pedicle screws are the most common strategy to maximize pullout strength for fixation of osteoporotic spines. Hybrid constructs, a combination of pedicle screws and hooks, offer an alternative approach to avoid implant failure and increasing construct stability when placing instrumentation in the osteoporotic spine. Biomechanical studies of either cement-augmented pedicle screws or combined pedicle screws and hooks for osteoporotic spine have demonstrated superior results compared to pedicle screws only in terms of improving implant pullout strength. However, few clinical investigation to date has focused on comparing surgical results of the cement-augmented pedicle screws (CPS) and hybrid construct (HC) techniques. The goal of the retrospective cohort study was to compare the surgical outcomes and surgery-, patient- and implant-related complications between the CPS and HC techniques for osteoporotic vertebral fractures in the thoracic or lumbar spine.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cement-augmented Pedicle Screws (CPS) Group | – | Procedure: Cement-augmented Pedicle Screws (CPS) |
| Hybrid Construct (HC) group | – | Procedure: Hybrid Construct (HC) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who underwent surgical treatment with CPS or HC of pedicle screws and hooks for osteoporotic fractures in the thoracic or lumbar spine in our hospital from January 2011 through December 2015
Key inclusion criteria (2 listed)
- Surgical treatment with CPS or HC of pedicle screws and hooks for osteoporotic fractures in the thoracic or lumbar spine
- Received a minimum of 2-year follow-up
Key exclusion criteria (4 listed)
- T-scores greater than -2.5
- Cancer metastasis
- Chronic osteomyelitis
- Failure to complete the questionnaires or radiographic examinations
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 |
|---|---|---|
| Cement-augmented Pedicle Screws (CPS)Patients who received surgical treatment with CPS for osteoporotic fractures in the thoracic or lumbar spine | Procedure or surgery | Cement-augmented Pedicle Screws (CPS) Group |
| Hybrid Construct (HC)Patients who received surgical treatment with HC consisting of pedicle screws and additional hooks for osteoporotic fractures in the thoracic or lumbar spine | Procedure or surgery | Hybrid Construct (HC) group |
Primary outcome
Implant Failure
Time frame: Postoperative 1 year
Implant failure was defined as pull-out or breakage of the implants on plain X-ray film.
Kyphotic Angle
Time frame: Preoperative
Cobb's method was used to measure the regional kyphotic angle
Kyphotic Angle
Time frame: Postoperative 1 month.
Cobb's method was used to measure the regional kyphotic angle
Kyphotic Angle
Time frame: Postoperative 2 months.
Cobb's method was used to measure the regional kyphotic angle
Kyphotic Angle
Time frame: Postoperative 3 months.
Cobb's method was used to measure the regional kyphotic angle
Kyphotic Angle
Time frame: Postoperative 6 months.
Cobb's method was used to measure the regional kyphotic angle
Kyphotic Angle
Time frame: Postoperative 12 months.
Cobb's method was used to measure the regional kyphotic angle
Visual Analogue Scale (VAS)
Time frame: Preoperative
Functional outcomes, Back pain evaluated
Visual Analogue Scale (VAS)
Time frame: Postoperative 1 month.
Functional outcomes, Back pain evaluated
Visual Analogue Scale (VAS)
Time frame: Postoperative 2 months.
Functional outcomes, Back pain evaluated
Visual Analogue Scale (VAS)
Time frame: Postoperative 3 months.
Functional outcomes, Back pain evaluated
Visual Analogue Scale (VAS)
Time frame: Postoperative 6 months.
Functional outcomes, Back pain evaluated
Visual Analogue Scale (VAS)
Time frame: Postoperative 12 months.
Functional outcomes, Back pain evaluated
Oswestry Disability Index (ODI)
Time frame: Preoperative
Functional outcomes, Disability evaluated
Oswestry Disability Index (ODI)
Time frame: Postoperative 1 month.
Functional outcomes, Disability evaluated
Oswestry Disability Index (ODI)
Time frame: Postoperative 2 months.
Functional outcomes, Disability evaluated
Oswestry Disability Index (ODI)
Time frame: Postoperative 3 months.
Functional outcomes, Disability evaluated
Oswestry Disability Index (ODI)
Time frame: Postoperative 6 months.
Functional outcomes, Disability evaluated
Oswestry Disability Index (ODI)
Time frame: Postoperative 12 months.
Functional outcomes, Disability evaluated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
Related trials for Osteoporosis
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
RecruitingObservational study
Glucocorticoid-induced Osteoporosis in Patients With Chronic Inflammatory Rheumatic Diseases or Psoriasis
Osteoporosis, Inflammatory Rheumatism
Not yet recruiting
Exercise and Fall Prevention for Fracture Reduction
Osteopenia, Osteoporosis
Active, not recruiting
Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes
Type 2 Diabetes, Osteoporosis
Recruiting
Surgeon-Initiated Bone Health Referral Pathway in Patients Undergoing Lower Extremity Arthroplasty
Osteoporosis, Arthroplasty Complications
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.
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 Osteoporosis, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 2 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: status not confirmed, as of the sponsor's last update on 23 Nov 2021. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shih-Tien Wang, MD (886-2-28757557 ext. 9, stwang@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Failure (time frame: Postoperative 1 year). The study lists 19 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 23 Nov 2021.