Reduction Deformity of LimbNCT03647410
Lumbopelvic Fixation Versus Novel Adjustable Plate for Displaced Sacral Fracture
An observational study of Reduction Deformity of Limb, run by Hebei Medical University Third Hospital at 1 site in China.
Trial summary
Patients of unilaterally displaced sacral fractures fixed with lumbopelvic technique or novel adjustable plate from June 2011 to June 2017 were recruited into this study and were divided into two groups: group A (lumbopelvic fixation) and groups B (novel adjustable plate). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Reduction Deformity of Limb
- What is being tested?
- lumbopelvic fixation
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Jun 2011to Sep 2018
- 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 to 65 years
- All sexes
- Adult, Older adult
Study population: Patients of unilateral displaced sacral fractures from June 2011 to June 2017 were recruited into this study. The inclusion criteria were as follows: 18-65 years, with normal activity ability before injury, fixed with lumbopelvic technique or novel adjustable plate, completed more than a year follow-up. The exclusion criteria were as follows: pathologic fractures, open fractures, associated with other severe injuries (traumatic brain injury), risk factors affecting bone healing (osteoporosis, smoking, and metabolic diseases) and non-completion of one-year follow-up.
Who may be able to join
- 18-65 years, with normal activity ability before injury
- Fixed with lumbopelvic technique or novel adjustable plate
- Completed more than a year follow-up
Who cannot join
- Pathologic fractures
- Open fractures
- Associated with other severe injuries (traumatic brain injury)
- Risk factors affecting bone healing (osteoporosis, smoking, and metabolic diseases)
- Non-completion of one-year follow-up
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, 050051
Yingze Zhang, M.D, +8613313012888, yzzhangdr@126.com
About this study
Official title: Lumbopelvic Fixation Versus Novel Adjustable Plate for Displaced Sacral Fractures: A Retrospective Cohort Study
Patients of unilaterally displaced sacral fractures fixed with lumbopelvic technique or novel adjustable plate from June 2011 to June 2017 were recruited into this study and were divided into two groups: group A (lumbopelvic fixation) and groups B (novel adjustable plate). Surgical time, intraoperative blood loss, frequency of intraoperative fluoroscopy, reduction quality, related complications were reviewed. Fracture healing was assessed by the radiographs conducted at follow-up. Functional outcome was evaluated according to the Majeed score at the final follow-up.
Read the detailed description
Patients of unilateral displaced sacral fractures from June 2011 to June 2017 were recruited into this study. The inclusion criteria were as follows: 18-65 years, with normal activity ability before injury, fixed with lumbopelvic technique or novel adjustable plate, completed more than a year follow-up. The exclusion criteria were as follows: pathologic fractures, open fractures, associated with other severe injuries (traumatic brain injury), risk factors affecting bone healing (osteoporosis, smoking, and metabolic diseases) and non-completion of one-year follow-up. Surgical time, intraoperative blood loss, frequency of intraoperative fluoroscopy, related complications were reviewed. Reduction quality was assessed on the postoperative radiographs and CT scans. Functional outcome was evaluated according to the Majeed score system at the final follow-up.
- Conditions
- Reduction Deformity of Limb
- Being tested
- lumbopelvic fixation
- Medical subject headings
- Ectromelia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbopelvic fixationDevice
Also called novel adjustable plate
Sacral fractures fixed with lumbopelvic fixation or novel adjustable plate were divided into two groups. Surgical time, intraoperative blood loss, frequency of intraoperative fluoroscopy, reduction quality, related complications, and functional outcome were reviewed.
| Study group | Role | What they receive |
|---|---|---|
| lumbopelvic fixation | sacral fractures fixed with lumbopelvic fixation | |
| novel adjustable plate | sacral fractures fixed with novel adjustable plate Receives: Device: lumbopelvic fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative reduction quality of sacral fractures after different surgical techniques
maximum displacement distance of the sacral fracture in the postoperative CT scans
Measured: 1 year
Secondary outcomes (1)
the incidence of complication
the incidence of wound infection, iatrogenic injury of vessels and nerves, nonunion
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study startJun 2011
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reduction Deformity of LimbStudies 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
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruipeng Zhang, Principal investigator, Third Hospital of Hebei Medical University Department of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647410
- Sponsor's protocol ID
- RPZ2018
- Status last verified
- Jun 2018
- First submitted
- 21 Aug 2018
- Last updated
- 27 Aug 2018
- 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 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbopelvic Fixation Versus Novel Adjustable Plate for Displaced Sacral Fractures: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT03647410
- Acronym / sponsor ID
- RPZ2018
- Conditions
- Reduction Deformity of Limb
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hebei Medical University Third HospitalUniversity, hospital or other
- Study start
- Jun 2011 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 27 Aug 2018 (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.
Patients of unilaterally displaced sacral fractures fixed with lumbopelvic technique or novel adjustable plate from June 2011 to June 2017 were recruited into this study and were divided into two groups: group A (lumbopelvic fixation) and groups B (novel adjustable plate). Surgical time, intraoperative blood loss, frequency of intraoperative fluoroscopy, reduction quality, related complications were reviewed. Fracture healing was assessed by the radiographs conducted at follow-up. Functional outcome was evaluated according to the Majeed score at the final follow-up.
Detailed description
Patients of unilateral displaced sacral fractures from June 2011 to June 2017 were recruited into this study. The inclusion criteria were as follows: 18-65 years, with normal activity ability before injury, fixed with lumbopelvic technique or novel adjustable plate, completed more than a year follow-up. The exclusion criteria were as follows: pathologic fractures, open fractures, associated with other severe injuries (traumatic brain injury), risk factors affecting bone healing (osteoporosis, smoking, and metabolic diseases) and non-completion of one-year follow-up. Surgical time, intraoperative blood loss, frequency of intraoperative fluoroscopy, related complications were reviewed. Reduction quality was assessed on the postoperative radiographs and CT scans. Functional outcome was evaluated according to the Majeed score system at the final follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lumbopelvic fixation | – | –sacral fractures fixed with lumbopelvic fixation |
| novel adjustable plate | – | Device: lumbopelvic fixationsacral fractures fixed with novel adjustable plate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients of unilateral displaced sacral fractures from June 2011 to June 2017 were recruited into this study. The inclusion criteria were as follows: 18-65 years, with normal activity ability before injury, fixed with lumbopelvic technique or novel adjustable plate, completed more than a year follow-up. The exclusion criteria were as follows: pathologic fractures, open fractures, associated with other severe injuries (traumatic brain injury), risk factors affecting bone healing (osteoporosis, smoking, and metabolic diseases) and non-completion of one-year follow-up.
Key inclusion criteria (3 listed)
- 18-65 years, with normal activity ability before injury
- Fixed with lumbopelvic technique or novel adjustable plate
- Completed more than a year follow-up
Key exclusion criteria (5 listed)
- Pathologic fractures
- Open fractures
- Associated with other severe injuries (traumatic brain injury)
- Risk factors affecting bone healing (osteoporosis, smoking, and metabolic diseases)
- Non-completion of one-year follow-up
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 |
|---|---|---|
| lumbopelvic fixationAlso: novel adjustable plateSacral fractures fixed with lumbopelvic fixation or novel adjustable plate were divided into two groups. Surgical time, intraoperative blood loss, frequency of intraoperative fluoroscopy, reduction quality, related complications, and functional outcome were reviewed. | Device | novel adjustable plate |
Primary outcome
postoperative reduction quality of sacral fractures after different surgical techniques
Time frame: 1 year
maximum displacement distance of the sacral fracture in the postoperative CT scans
1 secondary outcome
the incidence of complication
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
- 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. This study is not recruiting at the moment.
Ruipeng Zhang principal investigator
Third Hospital of Hebei Medical University Department of Orthopaedic Surgery
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 Reduction Deformity of Limb, run by Hebei Medical University Third Hospital 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 3 inclusion and 5 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 27 Aug 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruipeng Zhang (+8615613390624, zhangruipengdoctor@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative reduction quality of sacral fractures after different surgical techniques (time frame: 1 year). 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 27 Aug 2018.