Acetabular FractureNCT06005753
Surgical Treatment of Injuries and Consequences of the Acetabulum
A study testing Ostheosynthesis of acetabular fractures in people with Acetabular Fracture, run by National Scientific Center of Traumatology and Orthopedics named after academician N.D. Batpenov at 1 site in Kazakhstan.
Trial summary
The aim of the program is to develop technologies for the diagnosis and treatment of injuries and consequences of the pelvis. Purpose: to improve the technique of surgical treatment of acetabular fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acetabular Fracture
- What is being tested?
- Ostheosynthesis of acetabular fractures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteKazakhstan
- Study dates
- 25 Nov 2021to 31 Dec 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over 18 years of age
- patients with acetabular fractures undergoing surgery
- acetabular fractures according to the classification of Judet and Letournel
Who cannot join
- patients under 18 years of age
- posterior wall fracture according to the classification of Judet and Letournel
Trial locations and contacts
1 site in 1 country.
Kazakhstan1 site, 1 recruiting
- Recruiting
Center of National Scientific center Of Traumatology and Orthopedics named after academician N.D. Batpenov
Astana, 010000
Nagmet Mursalov, PhD, +77078553651, nagmet2007@mail.ru
Nurgeldi Manap, PhD student, +77078088656, nurgeldi.manap@gmail.com
About this study
Official title: Improving the Surgical Treatment of Injuries and Consequences of Injuries of the Acetabulum
The aim of the program is to develop technologies for the diagnosis and treatment of injuries and consequences of the pelvis.
Purpose: to improve the technique of surgical treatment of acetabular fractures.
Read the detailed description
Tasks: Implementation of low-traumatic access to the acetabulum; introduction of a new implant for osteosynthesis of complex acetabular fractures into clinical practice; мathematical modeling of fixation of the acetabulum with a new implant; рublication of the results of the work carried out The relevance of the use of new implants in orthopedics is due to the problem of adaptation of implants in the body, especially with poor quality of bone tissue. Currently, work is underway to improve the materials and shapes of implants, new alloys are being studied, polymer implants are being introduced, but the problem of their integration into bones remains. A promising direction in orthopedics is the creation of implants as close as possible in their morphological shape and elasto-strength properties to human bone. But the creation of an absolute copy of the bone structure from a metal alloy leads to a weakening of its strength and loss of fixation stability, and subsequent lysis of the adjacent bone tissue.
All this indicates the need for further search for new, perhaps more promising and effective ways to solve this problem.
- Conditions
- Acetabular Fracture
- Being tested
- Ostheosynthesis of acetabular fractures
- Keywords
- acetabulum, osteosynthesis, Stoppa approach, fracture
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ostheosynthesis of acetabular fracturesProcedure or surgery
The using of plate for fixation of acetabular fractures in surgical treatment
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Surgical intervention group Receives: Procedure: Ostheosynthesis of acetabular fractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
consolidation of fracture
Evaluation of results using the radiological Matta criterion, the Harris Hip Score
Measured: 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start25 Nov 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acetabular FractureStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Scientific Center of Traumatology and Orthopedics named after academician N.D. Batpenov
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Olzhas Bekarissov, National Scientific Center of Traumatology and Orthopedics named after academician N.D. Batpenov
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005753
- Sponsor's protocol ID
- BR11065157(04)
- Status last verified
- Aug 2023
- First submitted
- 15 Aug 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Surgical Treatment of Injuries and Consequences of Injuries of the Acetabulum
- ClinicalTrials.gov ID
- NCT06005753
- Acronym / sponsor ID
- BR11065157(04)
- Conditions
- Acetabular Fracture
- Keywords
- acetabulum, osteosynthesis, Stoppa approach, fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Scientific Center of Traumatology and Orthopedics named after academician N.D. BatpenovOther government
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 22 Aug 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.
The aim of the program is to develop technologies for the diagnosis and treatment of injuries and consequences of the pelvis.
Purpose: to improve the technique of surgical treatment of acetabular fractures.
Detailed description
Tasks: Implementation of low-traumatic access to the acetabulum; introduction of a new implant for osteosynthesis of complex acetabular fractures into clinical practice; мathematical modeling of fixation of the acetabulum with a new implant; рublication of the results of the work carried out The relevance of the use of new implants in orthopedics is due to the problem of adaptation of implants in the body, especially with poor quality of bone tissue. Currently, work is underway to improve the materials and shapes of implants, new alloys are being studied, polymer implants are being introduced, but the problem of their integration into bones remains. A promising direction in orthopedics is the creation of implants as close as possible in their morphological shape and elasto-strength properties to human bone. But the creation of an absolute copy of the bone structure from a metal alloy leads to a weakening of its strength and loss of fixation stability, and subsequent lysis of the adjacent bone tissue.
All this indicates the need for further search for new, perhaps more promising and effective ways to solve this problem.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Ostheosynthesis of acetabular fracturesSurgical intervention group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients over 18 years of age
- patients with acetabular fractures undergoing surgery
- acetabular fractures according to the classification of Judet and Letournel
Key exclusion criteria (2 listed)
- patients under 18 years of age
- posterior wall fracture according to the classification of Judet and Letournel
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 |
|---|---|---|
| Ostheosynthesis of acetabular fracturesThe using of plate for fixation of acetabular fractures in surgical treatment | Procedure or surgery | Group A |
Primary outcome
consolidation of fracture
Time frame: 1 year follow-up
Evaluation of results using the radiological Matta criterion, the Harris Hip Score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Individual participant dataSharing planned: No
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Pelvic and Acetabular Fracture: A Prospective Observational Study
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ostheosynthesis of acetabular fractures in people with Acetabular Fracture, run by National Scientific Center of Traumatology and Orthopedics named after academician N.D. Batpenov at 1 site in Kazakhstan.
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 2 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 22 Aug 2023. 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 Kazakhstan. 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 Nagmet Mursalov, Phd (+77078553651, nagmet2007@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
consolidation of fracture (time frame: 1 year 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 22 Aug 2023.