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

Metacarpal Fracture Clinical Trial

— Boxerfx  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06449755
• Other study ID #: 159108493
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: February 1, 2025

Study information

• Verified date: June 2024
• Source: Istanbul University
• Contact: Ahmet Muçteba AM Yildirim, Fellow
• Phone: +090 534 3038472
• Email: mucceba[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: February 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Boxer's Fracture
• Fractures, Bone
• Metacarpal Fracture

Intervention

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.

Locations

Country	Name	City	State
Turkey	Istanbul University Medicine Faculty Orthopaedic Department	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	Grip Strength	Hand grip strength will be measured with CAMBRY hand dynamometer at 1 and 3 months postoperatively.	Postoperative first and third month