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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05837182
Collaborator
(none)
30
23.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: augmented fixation techniques

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 Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
The Role of Augmented Fixation Techniques in Fragility Fracture Pelvis (FFP)
Anticipated Study Start Date :
May 6, 2023
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
May 1, 2025

Outcome Measures

Primary Outcome Measures

  1. assess improvement 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

  1. assess improvement in functional outcome [6 months and one year]

    using Postel Merle d'Aubigné score

  2. assess progression in radiological union and complications [X ray at 6 weeks, 6 months and one year one year CT at 6 months and one year]

    using X ray and CT

  3. one year mortality rate [one year]

    mortality rate at one year

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Principal Investigator: Ahmed M Seleem, MBBS, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ahmed Mokhtar Seleem, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05837182
Other Study ID Numbers:
  • augmented fixation in FFP
First Posted:
May 1, 2023
Last Update Posted:
May 1, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 1, 2023