search
Back to results

Early Functional Outcomes in Unisplaced Neck of Femur Fracture Treated With Partially Threaded and Fully Threaded Cannulated Screw Fixation in Patients of Age 60 and Above

Primary Purpose

Neck of Femur Fracture

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Fully threaded cannulated screws
Sponsored by
Nishtar Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck of Femur Fracture focused on measuring Cannulated screw, fracture, Hip Harris score

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients of garden type I or II fractures.
  • All patients to be mobile before femoral neck fracture.

Exclusion Criteria:

  • Patients having open fracture.
  • Patients with present or past history of chronic kidney disorder.
  • Patients presenting with hemorrhage.
  • Patient with nervous stroke
  • Patients unwilling to be part of this study.

Sites / Locations

  • Nishtar Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Partially threaded cannulated screw fixation

Fully threaded cannulated screws fixation

Arm Description

In Group-A patients, cannulated screw fixation was done using partially threaded screws. In this procedure, first step was insertion of three guide wires under image. The 1st guide wire was inserted immediately above calcar and into femoral head. The second wire was placed posteriorly adjacent to posterior cortex of neck on lateral view. Finally, third guide wire was placed anteriorly and superiorly. Drilling of lateral cortex was done before insertion of screws. Then partially threaded screw fixation was done before removal of guide wires using washers.

The surgical approach in fully thread cannulated screws fixation group will remain same but instead of partially threaded screwsm fully threaded screws to be used in this group.

Outcomes

Primary Outcome Measures

Harris Hip Score (RUSH SCORE)
Harris Hip Score (RUSH SCORE) is the method to assess the result of hip surgery and is intended to evaluate various hip disabilities and methods of treatment. RUSH Score was calculated with "Rradiographic Union Score for Hip (RUSH)", designed to improve intra-and inter-observer reliability when describing the radiographic healing.

Secondary Outcome Measures

Full Information

First Posted
October 17, 2022
Last Updated
October 17, 2022
Sponsor
Nishtar Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT05587660
Brief Title
Early Functional Outcomes in Unisplaced Neck of Femur Fracture Treated With Partially Threaded and Fully Threaded Cannulated Screw Fixation in Patients of Age 60 and Above
Official Title
Early Functional Outcomes in Unisplaced Neck of Femur Fracture Treated With Partially Threaded and Fully Threaded Cannulated Screw Fixation in Patients of Age 60 and Above
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nishtar Medical 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
This study is done to compare the partially threaded versus fully threaded cannulated screw fixation methods in stable neck of femur fracture in terms of early functional outcomes in patients of age 60 and above. A total of 82 (41 in each group) patients of both genders, aged 60 or above. The Radiographic Union Scale for Hip (RUSH) and Harris Hip score to be used to evaluate fracture healing.
Detailed Description
This study is done to compare the partially threaded versus fully threaded cannulated screw fixation methods in stable neck of femur fracture in terms of early functional outcomes in patients of age 60 and above. This is a randomized controlled trial where a total of 82 (41 in each group) patients of both genders, aged 60 or above. All these patients had garden type I or II and were mobile before femoral neck fracture were included. In Group-A patients cannulated screw fixation was done using partially threaded screws and in Group-B patients were treated with fully threaded screws were used. Patients were treated according to following schedule and were followed up at 6 weeks, 3 months and 6 months interval. The Radiographic Union Scale for Hip (RUSH) and Harris Hip score were used to evaluate fracture healing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck of Femur Fracture
Keywords
Cannulated screw, fracture, Hip Harris score

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Randomization to be done through lottery method and then the allocation to be made in both study groups.
Masking
None (Open Label)
Masking Description
No masking
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Partially threaded cannulated screw fixation
Arm Type
Experimental
Arm Description
In Group-A patients, cannulated screw fixation was done using partially threaded screws. In this procedure, first step was insertion of three guide wires under image. The 1st guide wire was inserted immediately above calcar and into femoral head. The second wire was placed posteriorly adjacent to posterior cortex of neck on lateral view. Finally, third guide wire was placed anteriorly and superiorly. Drilling of lateral cortex was done before insertion of screws. Then partially threaded screw fixation was done before removal of guide wires using washers.
Arm Title
Fully threaded cannulated screws fixation
Arm Type
Experimental
Arm Description
The surgical approach in fully thread cannulated screws fixation group will remain same but instead of partially threaded screwsm fully threaded screws to be used in this group.
Intervention Type
Procedure
Intervention Name(s)
Fully threaded cannulated screws
Intervention Description
The most popular method in undisplaced neck of femur fracture include internal fixation by cannulated screws in which screws can be inserted relatively simply and atraumatically as compared to other methods. Screws can be used partially threaded or fully threaded; however studies on fully threaded screw fixation method are inconclusive.
Primary Outcome Measure Information:
Title
Harris Hip Score (RUSH SCORE)
Description
Harris Hip Score (RUSH SCORE) is the method to assess the result of hip surgery and is intended to evaluate various hip disabilities and methods of treatment. RUSH Score was calculated with "Rradiographic Union Score for Hip (RUSH)", designed to improve intra-and inter-observer reliability when describing the radiographic healing.
Time Frame
6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients of garden type I or II fractures. All patients to be mobile before femoral neck fracture. Exclusion Criteria: Patients having open fracture. Patients with present or past history of chronic kidney disorder. Patients presenting with hemorrhage. Patient with nervous stroke Patients unwilling to be part of this study.
Facility Information:
Facility Name
Nishtar Medical University Hospital
City
Multān
State/Province
Punjab
ZIP/Postal Code
63100
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Early Functional Outcomes in Unisplaced Neck of Femur Fracture Treated With Partially Threaded and Fully Threaded Cannulated Screw Fixation in Patients of Age 60 and Above

We'll reach out to this number within 24 hrs