NCT05587660

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2022

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

1.1 years

First QC Date

October 17, 2022

Last Update Submit

October 17, 2022

Conditions

Keywords

Cannulated screwfractureHip Harris score

Outcome Measures

Primary Outcomes (1)

  • 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.

    6-months

Study Arms (2)

Partially threaded cannulated screw fixation

EXPERIMENTAL

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.

Procedure: Fully threaded cannulated screws

Fully threaded cannulated screws fixation

EXPERIMENTAL

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.

Procedure: Fully threaded cannulated screws

Interventions

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.

Fully threaded cannulated screws fixationPartially threaded cannulated screw fixation

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nishtar Medical University Hospital

Multan Khurd, Punjab Province, 63100, Pakistan

Location

Related Publications (1)

  • Awais MZ, Salik E, Bokhari SHR, Iqbal MT. A comparative study of early functional outcomes in undisplaced neck of femur fracture treated with partially threaded and fully threaded cannulated screw fixation in patients above 60 years age. Pak J Med Sci. 2023 Sep-Oct;39(5):1531-1534. doi: 10.12669/pjms.39.5.7330.

MeSH Terms

Conditions

Femoral Neck FracturesFractures, Bone

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: Randomization to be done through lottery method and then the allocation to be made in both study groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Gynecologist

Study Record Dates

First Submitted

October 17, 2022

First Posted

October 20, 2022

Study Start

July 1, 2021

Primary Completion

July 30, 2022

Study Completion

July 30, 2022

Last Updated

October 20, 2022

Record last verified: 2022-10

Locations