The Role of Augmented Fixation Techniques in Fragility Fracture Pelvis (FFP)

Not yet recruiting

• Conditions: Fragility Fracture

• Registration Number: NCT05837182
• Lead Sponsor: Assiut University

Brief Summary

Assessment of the role of augmented fixation of fragility fracture pelvis in improving functional outcome as a primary outcome and improving union and decreasing mortality and complications as secondary outcomes at 6 months and one year follow up.

Detailed Description

During the process of aging, the quality of bones deteriorates making bones more vulnerable for fractures after minor trauma or from normal daily activities. This poor bone quality together with comorbidities increase healing problems and complications and make fixation more difficult. Moreover, immobilization due to fractures has serious complications especially in the elderly. For all theses, fragility fracture-which is defined by WHO as a fracture that is caused by an injury that would be insufficient to fracture normal bones and is the result of reduced compressive and or torsional strength of bone - these fractures have unique criteria making them a special category with its own concerns. One of these fractures is fragility fracture pelvis (FFP) which is expected to triple between 2005 and 2030. This type of fracture has its huge effect on morbidity and mortality of this vulnerable group of people. Due to its special criteria , a new classification system was developed to classify it known as Rommens classification system. This was followed by many literatures focused on this fracture, its morbidity and mortality, role of surgery, minimal invasive techniques and different augmentation fixation techniques, but they did not reach to a clear algorithm for management and did not clearly identify the role of augmented fixation techniques on different outcomes of this fracture . Fixation augmentation techniques which are defined as surgical techniques aimed at increasing implant stability and used in poor bone quality like in geriatric population. the investigators hypothesis is augmented fixation will improve the functional outcomes of fragility fracture pelvis. These techniques may include percutaneous transsarcal screws fixation, tension band plating, INFIX technique, triangular fixation and cement augmentation techniques.

the investigators will try to answer this question which is "what is the effect of augmented fixation techniques on functional outcomes of fragility fracture pelvis? ''.

Study Timeline

• Study First Submitted: 2023-04-06
• Study First Submitted QC: 2023-04-19
• Status Verified: 2023-05
• Study First Posted: 2023-05-01
• Study Start: 2023-05-06
• Last Update Submitted: 2023-05-16
• Last Update Posted: 2023-05-18
• Primary Completion: 2025-03
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients above age of sixty years.
2. Fragility fracture pelvis
3. injury severity score below 17.
4. Controlled comorbidities

Exclusion Criteria

1. Malignancy in bony pelvis.
2. Chronic kidney disease on regular dialysis,
3. Skin lesion at admission like Morel-Lavallée lesion.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
assess change in functional outcome of augmented fixation techniques in fragility fracture pelvis	at 6 weeks, 6 months and one year	functional outcome using Majeed score system(0 to 100) with 100 is best outcome

Secondary Outcome Measures

Name	Time	Method
one year mortality rate	one year	mortality rate at one year
assess change in radiological union and complications	CT at 6 months and one year	using CT