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

NCT ID: NCT05587660

Last Updated: 2022-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-07-30

Brief Summary

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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

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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.

Conditions

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Neck of Femur Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Randomization to be done through lottery method and then the allocation to be made in both study groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

No masking

Study Groups

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Partially threaded cannulated screw fixation

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.

Group Type EXPERIMENTAL

Fully threaded cannulated screws

Intervention Type PROCEDURE

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 fixation

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.

Group Type EXPERIMENTAL

Fully threaded cannulated screws

Intervention Type PROCEDURE

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.

Interventions

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Fully threaded cannulated screws

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nishtar Medical University

OTHER

Sponsor Role lead

Responsible Party

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Rashida Parveen

Consultant Gynecologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nishtar Medical University Hospital

Multan Khurd, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type DERIVED
PMID: 37680815 (View on PubMed)

Other Identifiers

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NishtarMU123

Identifier Type: -

Identifier Source: org_study_id

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