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

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.

Study Overview

• Status: Completed
• Conditions: Neck of Femur Fracture
• Intervention / Treatment: Procedure: Fully threaded cannulated screws

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.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Multān, Punjab, Pakistan, 63100
      • Nishtar Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 56 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.
Experimental: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nishtar Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: October 17, 2022
• First Submitted That Met QC Criteria: October 17, 2022
• First Posted (Actual): October 20, 2022

Study Record Updates

• Last Update Posted (Actual): October 20, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: fracture; Cannulated screw; Hip Harris score
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Hip Injuries; Hip Fractures; Femoral Fractures; Fractures, Bone; Femoral Neck Fractures
• Other Study ID Numbers: NishtarMU123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No