NCT05837182

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

May 6, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

May 18, 2023

Status Verified

May 1, 2023

Enrollment Period

1.8 years

First QC Date

April 6, 2023

Last Update Submit

May 16, 2023

Conditions

Fragility Fracture

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • assess change in radiological union and complications

    X ray at 6 weeks, 6 months and one year one year

  • assess change in radiological union and complications

    CT at 6 months and one year

  • one year mortality rate

    one year

Interventions

augmented fixation techniquesPROCEDURE

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

Eligibility Criteria

Age60 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

people above age of sixty males and females with fracture pelvis ,not polytraumatized without uncontrolled comorbidities

You may qualify if:

  • Patients above age of sixty years.
  • Fragility fracture pelvis
  • injury severity score below 17.
  • Controlled comorbidities

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 34850256BACKGROUND

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

    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.

    PMID: 23871193BACKGROUND

  • 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.

    PMID: 2925751BACKGROUND

  • 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.

    PMID: 36443346BACKGROUND

  • 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.

    PMID: 36220693BACKGROUND

  • 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.

    PMID: 34635938BACKGROUND

Study Officials

  • Ahmed M Seleem, MBBS

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ahmed M Seleem, MBBS

CONTACT

01017280633ahmedmokhtar@med.aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 6, 2023

First Posted

May 1, 2023

Study Start

May 6, 2023

Primary Completion

March 1, 2025

Study Completion

May 1, 2025

Last Updated

May 18, 2023

Record last verified: 2023-05