Surgical Treatment of Injuries and Consequences of the Acetabulum
Primary Purpose
Acetabular Fracture
Status
Recruiting
Phase
Not Applicable
Locations
Kazakhstan
Study Type
Interventional
Intervention
Ostheosynthesis of acetabular fractures
Sponsored by
About this trial
This is an interventional treatment trial for Acetabular Fracture focused on measuring acetabulum, osteosynthesis, Stoppa approach, fracture
Eligibility Criteria
Inclusion Criteria: patients over 18 years of age patients with acetabular fractures undergoing surgery acetabular fractures according to the classification of Judet and Letournel Exclusion Criteria: patients under 18 years of age posterior wall fracture according to the classification of Judet and Letournel
Sites / Locations
- Center of National Scientific center Of Traumatology and Orthopedics named after academician N.D. BatpenovRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Group A
Arm Description
Surgical intervention group
Outcomes
Primary Outcome Measures
consolidation of fracture
Evaluation of results using the radiological Matta criterion, the Harris Hip Score
Secondary Outcome Measures
Full Information
NCT ID
NCT06005753
First Posted
August 15, 2023
Last Updated
August 15, 2023
Sponsor
National Scientific Center of Traumatology and Orthopedics named after academician N.D. Batpenov
1. Study Identification
Unique Protocol Identification Number
NCT06005753
Brief Title
Surgical Treatment of Injuries and Consequences of the Acetabulum
Official Title
Improving the Surgical Treatment of Injuries and Consequences of Injuries of the Acetabulum
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Scientific Center of Traumatology and Orthopedics named after academician N.D. Batpenov
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acetabular Fracture
Keywords
acetabulum, osteosynthesis, Stoppa approach, fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Surgical intervention group
Intervention Type
Procedure
Intervention Name(s)
Ostheosynthesis of acetabular fractures
Intervention Description
The using of plate for fixation of acetabular fractures in surgical treatment
Primary Outcome Measure Information:
Title
consolidation of fracture
Description
Evaluation of results using the radiological Matta criterion, the Harris Hip Score
Time Frame
1 year follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients over 18 years of age
patients with acetabular fractures undergoing surgery
acetabular fractures according to the classification of Judet and Letournel
Exclusion Criteria:
patients under 18 years of age
posterior wall fracture according to the classification of Judet and Letournel
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nagmet Mursalov, Phd
Phone
+77078553651
Email
nagmet2007@mail.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Nurgeldi Manap, Phd student
Phone
+77078088656
Email
nurgeldi.manap@gmail.com
Facility Information:
Facility Name
Center of National Scientific center Of Traumatology and Orthopedics named after academician N.D. Batpenov
City
Astana
ZIP/Postal Code
010000
Country
Kazakhstan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nagmet Mursalov, PhD
Phone
+77078553651
Email
nagmet2007@mail.ru
First Name & Middle Initial & Last Name & Degree
Nurgeldi Manap, PhD student
Phone
+77078088656
Email
nurgeldi.manap@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Surgical Treatment of Injuries and Consequences of the Acetabulum
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