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Treatment Of Unstable Trochanteric Fracture: A Comparative Study Between DHS And DHS With Trochanteric Stabilization Plate

Primary Purpose

Trochanteric Fractures

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
dynamic hip screw
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trochanteric Fractures

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: pateints with comminution of medial femoral cortex and loss of continuity of lesser trochanter Exclusion Criteria: stable trochanteric fracture subtrochanteric extension reverse oblique trochanteric fracture

Sites / Locations

  • Sohag University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

DHS

DHS with Trochanteric stabilizing plate

Arm Description

patients with trochanteric fracture treated with DHS

patients with trochanteric fracture treated with DHS with trochanteric stabilizing plate

Outcomes

Primary Outcome Measures

neck shaft angle measurment .Harris hip score
measurment of neck shaft angle between two groups

Secondary Outcome Measures

Full Information

First Posted
March 12, 2023
Last Updated
March 12, 2023
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05781815
Brief Title
Treatment Of Unstable Trochanteric Fracture: A Comparative Study Between DHS And DHS With Trochanteric Stabilization Plate
Official Title
Treatment Of Unstable Trochanteric Fracture: A Comparative Study Between DHS And DHS With Trochanteric Stabilization Plate
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2023 (Actual)
Primary Completion Date
August 8, 2023 (Anticipated)
Study Completion Date
August 8, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
compare the results in treatment of unstable trochanteric fracture by using DHS and DHS with Trochanteric Stabilizing plate as regard shaft medialization.neck shaft angle measurment and shaft migration

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trochanteric Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DHS
Arm Type
Active Comparator
Arm Description
patients with trochanteric fracture treated with DHS
Arm Title
DHS with Trochanteric stabilizing plate
Arm Type
Active Comparator
Arm Description
patients with trochanteric fracture treated with DHS with trochanteric stabilizing plate
Intervention Type
Procedure
Intervention Name(s)
dynamic hip screw
Intervention Description
using dynamic hip screw in treatment of trochanteric fracture and dynamic hip screw with trochanteric stabilizing plate
Primary Outcome Measure Information:
Title
neck shaft angle measurment .Harris hip score
Description
measurment of neck shaft angle between two groups
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: pateints with comminution of medial femoral cortex and loss of continuity of lesser trochanter Exclusion Criteria: stable trochanteric fracture subtrochanteric extension reverse oblique trochanteric fracture
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Mo MOHAMED ABD EL ALEEM, resident
Phone
01114673751
Email
ahmedabdelalem@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Shazly sa saleh moussa, professor
Phone
01223856260
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
ZIP/Postal Code
Sohag
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
magdy m amin, professor

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
28284469
Citation
Babhulkar S. Unstable trochanteric fractures: Issues and avoiding pitfalls. Injury. 2017 Apr;48(4):803-818. doi: 10.1016/j.injury.2017.02.022. Epub 2017 Feb 27.
Results Reference
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PubMed Identifier
12151898
Citation
Ahrengart L, Tornkvist H, Fornander P, Thorngren KG, Pasanen L, Wahlstrom P, Honkonen S, Lindgren U. A randomized study of the compression hip screw and Gamma nail in 426 fractures. Clin Orthop Relat Res. 2002 Aug;(401):209-22. doi: 10.1097/00003086-200208000-00024.
Results Reference
background
PubMed Identifier
13242603
Citation
SCHUMPELICK W, JANTZEN PM. A new principle in the operative treatment of trochanteric fractures of the femur. J Bone Joint Surg Am. 1955 Jul;37-A(4):693-8. No abstract available.
Results Reference
background
PubMed Identifier
5783851
Citation
Harris WH. Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty. An end-result study using a new method of result evaluation. J Bone Joint Surg Am. 1969 Jun;51(4):737-55. No abstract available.
Results Reference
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Learn more about this trial

Treatment Of Unstable Trochanteric Fracture: A Comparative Study Between DHS And DHS With Trochanteric Stabilization Plate

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