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

NCT ID: NCT05837182

Last Updated: 2023-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-06
• Study Completion Date: 2025-05-31

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? ''.

Conditions

Fragility Fracture

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

augmented fixation techniques

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mokhtar Seleem

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed M Seleem, MBBS

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

ahmed M Seleem, MBBS

Role: CONTACT

ahmedmokhtar@med.aun.edu.eg

01017280633

References

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.

Reference Type: BACKGROUND

PMID: 34850256 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 23871193 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2925751 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36443346 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36220693 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34635938 (View on PubMed)

Other Identifiers

augmented fixation in FFP

Identifier Type: -

Identifier Source: org_study_id