Clinical trial NCT05837182: The Role of Augmented Fixation Techniques in Fragility Fracture Pelvis (FFP)
Official title: The Role of Augmented Fixation Techniques in Fragility Fracture Pelvis (FFP)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fragility Fracture
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: people above age of sixty males and females with fracture pelvis ,not polytraumatized without uncontrolled comorbidities

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? ''.

Eligibility criteria: 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.

Primary outcomes:
measure: assess change in functional outcome of augmented fixation techniques in fragility fracture pelvis
timeFrame: at 6 weeks, 6 months and one year
Secondary outcomes:
measure: assess change in radiological union and complications
timeFrame: X ray at 6 weeks, 6 months and one year one year
measure: assess change in radiological union and complications
timeFrame: CT at 6 months and one year
measure: one year mortality rate
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Ahmed M Seleem, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Rommens PM, Hofmann A. Fragility fractures of the pelvis. Cham: Springer International Publishing; 2017
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.
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.
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.
citation: 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.
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.