Elastic Nail Versus Screw for Intramedullary Fixation of Displaced Fractures of the Fifth Metacarpal Neck (Boxerfx)

Elastic Nail Versus Screw for Closed Reduction and Intramedullary Fixation of Displaced Fractures of the Fifth Metacarpal Neck: a Randomised Controlled Trial

The goal of this clinical trial is to compare two different intramedullary fixation technique in patient diagnosed with deplased fifth metacarpal neck fracture. The main questions it aims to answer are:

• Can percutaneous screw application be a more stable fixation method than intramedullary elastic nail application?
• Can screw application create a significant difference in the recovery of grip strength in the early period compared to elastic nail application? Patients will be followed up at the 1st week, 1st month and 3rd month postoperatively. Functionality will be evaluated with Quick DASH score at the 3rd month. At the 1st and 3rd month controls, grip strength will be evaluated. At the same time, metacarpal shortening and angulations will be measured on x-ray. Researchers will compare percutaneous screw and elastic nail group to see grip strength, healing time and radiologic parameter difference.

Study Overview

• Status: Recruiting
• Conditions: Metacarpal Fracture; Boxer's Fracture
• Intervention / Treatment: Diagnostic test: Radiologic examination; Procedure: Grip Strength; Other: Quick DASH Questionnaire

Detailed Description

In this study, patients admitted to the emergency department with displaced fifth metacarpal neck fracture will be included. Exclusion criteria will include patients with other concomitant trauma, open fractures, fractures with intraarticular joint extension, and previous hand surgery in which the hand anatomy was distorted. Patients between the ages of 18 and 60 who have more than 30 degrees of angulation from the 30 degree hand pronation radiograph at admission and who consent to surgery will be included in the study. One of the two groups in the study will undergo closed reduction followed by percutaneous intramedullary retrograde screw fixation, while the other group will undergo intramedullary antegrade elastic nail application. Patients will be followed up with ulnar gutter splint for the first week postoperatively. After the first week, the splint will be removed and range of motion, gripping and pinching exercises will be given to the patients.

Radiological examinations (dorsal angulation and metacarpal shortening will be measured) will be performed in the first week, first and third months postoperatively. Hand grip strength will be measured with Cambry dynamometer at the first and third month. At the 3rd month, upper extremity functionality will be evaluated with Quick DASH score and a comparison will be made between the two groups.

Randomisation will be performed with an internet-based application. Clinical ethics committee approval was obtained before the study started.

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmet Muçteba AM Yıldırım, Fellow; Phone Number: +090 534 3038472; Email: mucceba@gmail.com

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey, 34080
      • Recruiting
      • Istanbul Unıversity Medicine Faculty Orthopaedic Department
      • Contact: Ahmet Muçteba AM Yıldırım, Fellow; Phone Number: +090 534 303 8472; Email: mucceba@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged 18-60 years with displaced fifth metacarpal fractures with angulation greater than 30 degrees

Exclusion Criteria:

• Open fracture
• Patients with multiple injuries
• History of hand surgery
• Intraarticular metacarpal neck fractures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Elastic Nail; Percutaneous antegrade elastic nail fixation	Diagnostic test: Radiologic examination; Posoperative first week, month and third month On the x-ray of Hand AP view: metacarpal shortening On the x-ray of Hand 30 degree pronation view: dorsal angulation; Procedure: Grip Strength; Postoperative first month and third month grip streng compare with Cambry hand dinamometer.; Other: Quick DASH Questionnaire; Quick DASH is an 11-question questionnaire that assesses upper extremity functionality.
Other: Screw; Percutaneous retrograde screw fixation	Diagnostic test: Radiologic examination; Posoperative first week, month and third month On the x-ray of Hand AP view: metacarpal shortening On the x-ray of Hand 30 degree pronation view: dorsal angulation; Procedure: Grip Strength; Postoperative first month and third month grip streng compare with Cambry hand dinamometer.; Other: Quick DASH Questionnaire; Quick DASH is an 11-question questionnaire that assesses upper extremity functionality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dorsal Angulation and Metacarpal Shortening	Measurement of dorsal angulation between two fracture fragments on a hand oblique 30-degree pronation X-Ray Measurement of shortness of the fifth metacarpal on hand AP X-ray	Preoperative, Postoperative first week, first and third month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grip Strength	Hand grip strength will be measured with CAMBRY hand dynamometer at 1 and 3 months postoperatively.	Postoperative first and third month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing Time	In follow-up X-rays, complete osseous bridging in 3 of 4 cortices and absence of pain in the patient will be taken as a sign of healing.	Preoperative, Postoperative first week, first and third month
Upper Extremity Functionality	Patients will be evaluated at the 3rd postoperative month with the Quick DASH 11-question questionnaire assessing upper extremity functionality.	Postoperative third month

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Principal Investigator: Serkan MD Bayram, MD, Assistant Professor

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 159108493

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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