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

NCT06449755 | Recruiting

• 1 other identifier: 159108493
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metacarpal Fracture; Boxer's Fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Grip Strength

  Postoperative first and third month

Other Outcomes (2)

• Healing Time

  Preoperative, Postoperative first week, first and third month

• Upper Extremity Functionality

  Postoperative third month

Study Arms (2)

Elastic Nail

OTHER

Percutaneous antegrade elastic nail fixation

Diagnostic Test: Radiologic examination; Procedure: Grip Strength; Other: Quick DASH Questionnaire

Screw

OTHER

Percutaneous retrograde screw fixation

Diagnostic Test: Radiologic examination; Procedure: Grip Strength; Other: Quick DASH Questionnaire

Interventions

Radiologic examination DIAGNOSTIC_TEST

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

Elastic Nail; Screw

Grip Strength PROCEDURE

Postoperative first month and third month grip streng compare with Cambry hand dinamometer.

Elastic Nail; Screw

Quick DASH Questionnaire OTHER

Quick DASH is an 11-question questionnaire that assesses upper extremity functionality.

Elastic Nail; Screw

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul Unıversity Medicine Faculty Orthopaedic Department

Istanbul, Fatih, 34080, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Diagnostic Imaging; Hand Strength

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Muscle Strength; Physical Examination; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Serkan MD Bayram, MD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmet Muçteba AM Yıldırım, Fellow

CONTACT

+090 534 3038472; mucceba@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 10, 2024
• Study Start: September 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)