Clinical trial NCT06449755: Elastic Nail Versus Screw for Intramedullary Fixation of Displaced Fractures of the Fifth Metacarpal Neck
Official title: Elastic Nail Versus Screw for Closed Reduction and Intramedullary Fixation of Displaced Fractures of the Fifth Metacarpal Neck: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metacarpal Fracture
Boxer's Fracture
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dorsal Angulation and Metacarpal Shortening
timeFrame: Preoperative, Postoperative first week, first and third month
Secondary outcomes:
measure: Grip Strength
timeFrame: Postoperative first and third month
Other outcomes:
measure: Healing Time
timeFrame: Preoperative, Postoperative first week, first and third month
measure: Upper Extremity Functionality
timeFrame: Postoperative third month
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Unıversity Medicine Faculty Orthopaedic Department
state: Fatih
Study officials:
affiliation: Assistant Professor
name: Serkan MD Bayram, MD
role: PRINCIPAL_INVESTIGATOR
References: