RecruitingACTRN12624000003572

Comparing Surgical Approaches for Displaced Hand Fractures: A Clinical Study of Intramedullary Screws versus Dorsal Plates

Comparison of Intramedullary Screw Fixation vs Plate and Screws for Metacarpal Fractures: A Randomized Control Trial Assessing Total Active Motion, Grip Strength, Hand Function, Pain, Complication Rates, and Operative Time at 3, 6, and 12 Months

Sponsor

Gold Coast Hospital and Health Services

Enrollment

100 participants

Start Date

Sep 10, 2025

Study Type

Interventional

Conditions

The health condition studied is surgical procedures for displaced extra-articular metacarpal fractures.

Summary

Extra-articular metacarpal fractures are a common injury that often require surgical intervention. There are two commonly used surgical methods for fixing these fractures: intramedullary screw fixation and dorsal plating. The optimal surgical method is currently unclear, with limited evidence available to guide clinical decision-making. This study aims to compare these two surgical methods to determine which produces better patient outcomes. This is a multicenter randomized controlled trial conducted in two hospitals in New South Wales and one hospital in Queensland, Australia. Patients with extra-articular metacarpal fractures will be recruited and randomly assigned to receive either intramedullary screw fixation or dorsal plating. The primary outcome measure is total active motion (TAM) of the involved digit at six weeks post-surgery. Secondary outcome measures include TAM of the involved digits at three, six, and 12 months, grip strength, hand function (as measured by the DASH and MHQ scores), pain, complication rates, and operative time. The study is designed to provide high-quality evidence to guide clinical decision-making regarding the optimal surgical method for fixing extra-articular metacarpal fractures. By comparing the two most commonly used surgical methods in a randomized controlled trial, this study will provide valuable information to help clinicians make informed decisions about the best way to treat these common injuries. The inclusion of three hospitals in two different states of Australia will help to ensure the generalizability of the results and increase the external validity of the study. Overall, this study has the potential to significantly improve patient outcomes and optimize the delivery of surgical care for patients with extra-articular metacarpal fractures.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Breaking a bone in the hand — specifically the metacarpal bones that form the knuckles — is one of the most common hand injuries, especially in young active people. When the fracture is displaced (the bone fragments have moved out of alignment), surgery is often needed. Two surgical techniques are commonly used: intramedullary screws (inserted through the knuckle into the bone canal) and dorsal plates (metal plates fixed to the back surface of the bone). Both are accepted approaches, but it is not clear which produces better outcomes. This multicentre randomised controlled trial at hospitals in New South Wales and Queensland is directly comparing these two techniques. Participants with displaced hand fractures are randomly assigned to one surgical approach or the other, and then followed for 12 months. The primary measure is how much the finger can move (total active motion) at 6 weeks post-surgery. Secondary measures include grip strength, hand function, pain, complications, and operative time. Eligible participants are adults 18 and over with a displaced extra-articular metacarpal fracture (not involving the joint surface) for which a surgeon has decided surgery is needed, within 14 days of the injury. Fractures with severe soft tissue damage, pathological fractures, or those only suitable for one fixation type are excluded.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Brief Name: Plates or Intramedullary Screws in Metacarpals: POSIM Trial This study is designed to compare two standard surgical treatments for displaced extra-articular metacarpal fractures: dorsal

Brief Name: Plates or Intramedullary Screws in Metacarpals: POSIM Trial This study is designed to compare two standard surgical treatments for displaced extra-articular metacarpal fractures: dorsal plating and retrograde intramedullary screw(s). Participants will be randomly assigned to one of these two treatment groups. The main intervention of interest is the retrograde intramedullary screw fixation, though the trial aims to evaluate the efficacy of both interventions. The surgeries will be conducted by orthopaedic surgeons, who are not identified by name for this registration, with expertise in hand surgery. In both treatment options, the expected duration, procedures, anesthesia, post-operative care, and other related elements remain the same. The only variation between the groups is the specific fixation method used, either screws or plates. Follow-ups will be scheduled to assess the total active motion (TAM) of the involved digits, grip strength, hand function, and pain levels at intervals of 6 weeks, 3, 6, and 12 months after surgery. To ensure consistency and fidelity to the intervention, an audit of hospital records, surgical procedure documentation, and regular monitoring by a designated clinical trial team will be carried out. This approach ensures adherence to the chosen intervention and allows for accurate reporting and assessment of the study outcomes.

Locations(3)

Gold Coast University Hospital - Southport

NSW,QLD, Australia

Nepean Hospital - Kingswood

NSW,QLD, Australia

Hornsby Ku-ring-gai Hospital - Hornsby

NSW,QLD, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12624000003572