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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06449755
Acronym
Boxerfx
Enrollment
46
Registered
2024-06-10
Start date
2023-09-01
Completion date
2025-02-01
Last updated
2024-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metacarpal Fracture, Boxer's Fracture

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.

Interventions

DIAGNOSTIC_TESTRadiologic 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

PROCEDUREGrip Strength

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

OTHERQuick DASH Questionnaire

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

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Dorsal Angulation and Metacarpal ShorteningPreoperative, Postoperative first week, first and third monthMeasurement 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

Secondary

MeasureTime frameDescription
Grip StrengthPostoperative first and third monthHand grip strength will be measured with CAMBRY hand dynamometer at 1 and 3 months postoperatively.

Other

MeasureTime frameDescription
Healing TimePreoperative, Postoperative first week, first and third monthIn 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.
Upper Extremity FunctionalityPostoperative third monthPatients will be evaluated at the 3rd postoperative month with the Quick DASH 11-question questionnaire assessing upper extremity functionality.

Countries

Turkey (Türkiye)

Contacts

Primary ContactAhmet Muçteba AM Yıldırım, Fellow
mucceba@gmail.com+090 534 3038472

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026