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

Fragility Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05837182
• Other study ID #: augmented fixation in FFP
• Status: Not yet recruiting
• Start date: May 6, 2023
• Est. completion date: May 2025

Study information

• Verified date: May 2023
• Source: Assiut University
• Contact: ahmed M Seleem, MBBS
• Phone: 01017280633
• Email: ahmedmokhtar[@]med.aun.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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? ''.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 2025
• Est. primary completion date: March 2025
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Fragility Fracture

Intervention

Procedure:
• augmented fixation techniques
augmented fixation techniques like percutaneous transsarcal screws fixation, tension band plating, INFIX technique, triangular fixation and cement augmentation techniques

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (7)

Haveman RA, Baumlein M, van Veelen N, Oberkircher L, Beeres FJP, Babst R, Ruchholtz S, Link BC. Percutaneous sacroiliac screw fixation in fragility fractures of the pelvis: Comparison of two different augmentation techniques. Injury. 2022 Dec;53(12):4062-4066. doi: 10.1016/j.injury.2022.09.050. Epub 2022 Oct 8. — View Citation

Kulakowski M, Reichert P, Elster K, Sleczka P, Oleksy L, Krolikowska A. Safety and efficacy of two ilioiliac tension band plates osteosynthesis of fragility fractures of the pelvis. Sci Rep. 2022 Nov 28;12(1):20436. doi: 10.1038/s41598-022-24525-7. — View Citation

Majeed SA. Grading the outcome of pelvic fractures. J Bone Joint Surg Br. 1989 Mar;71(2):304-6. doi: 10.1302/0301-620X.71B2.2925751. — View Citation

Omichi T, Takegami Y, Tokutake K, Saito Y, Ito O, Ando T, Imagama S. Mortality and functional outcomes of fragility fractures of the pelvis by fracture type with conservative treatment: a retrospective, multicenter TRON study. Eur J Trauma Emerg Surg. 2022 Aug;48(4):2897-2904. doi: 10.1007/s00068-021-01839-1. Epub 2021 Dec 1. — View Citation

Rommens PM, Hofmann A, Kraemer S, Kisilak M, Boudissa M, Wagner D. Operative treatment of fragility fractures of the pelvis: a critical analysis of 140 patients. Eur J Trauma Emerg Surg. 2022 Aug;48(4):2881-2896. doi: 10.1007/s00068-021-01799-6. Epub 2021 Oct 11. — View Citation

Rommens PM, Hofmann A. Comprehensive classification of fragility fractures of the pelvic ring: Recommendations for surgical treatment. Injury. 2013 Dec;44(12):1733-44. doi: 10.1016/j.injury.2013.06.023. Epub 2013 Jul 18. — View Citation

Rommens PM, Hofmann A. Fragility fractures of the pelvis. Cham: Springer International Publishing; 2017

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assess change in functional outcome of augmented fixation techniques in fragility fracture pelvis	functional outcome using Majeed score system(0 to 100) with 100 is best outcome	at 6 weeks, 6 months and one year
Secondary	assess change in radiological union and complications	using X ray	X ray at 6 weeks, 6 months and one year one year
Secondary	assess change in radiological union and complications	using CT	CT at 6 months and one year
Secondary	one year mortality rate	mortality rate at one year	one year