Intramedullary Screw Fixation Versus Closed Reduction and Percutaneous Pinning With Cast Immobilization
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSpencer B Chambers
About this trial
Broken bones in the hand are common injuries that can make it hard to move fingers, grip objects, and return to work. When these breaks happen in the long bones of the hand (called metacarpals and phalanges), surgery is often needed to hold the bones in the right place while they heal.
There are a few different ways surgeons can fix these broken bones. Two common methods are:
CRPP (Closed Reduction and Percutaneous Pinning): The bones are moved back into place without opening the skin, and thin metal pins are used to hold them.
IMSF (Intramedullary Screw Fixation): A small screw is placed inside the bone to hold it in position.
Another approach sometimes used for larger bones in the hand is ORIF (Open Reduction and Internal Fixation), where the bone is exposed through a small incision and held with plates or screws.
This study will compare how well these methods work. Investigators want to find out if using an intramedullary screw (IMSF) helps patients heal faster and move their hands more easily compared to the other common methods (CRPP and ORIF). Investigators will look at how quickly patients regain movement, how soon they can return to work, how satisfied they are with their recovery, and whether there are any problems or complications from surgery.
To do this, investigators will run a randomized controlled trial-this means patients will be stratified based on fracture location (metacarpals or phalanges) and randomly assigned to a treatment arm. For patients with metacarpal fractures, investigators will compare IMSF vs CRPP vs ORIF using a dorsal plate. For patients with proximal or middle phalangeal fractures investigators will compare IMSF to CRPP. Investigators will measure their recovery using both clinical tests and patient surveys over time. The results of this research will help surgeons choose the best and safest way to treat hand fractures so patients can heal faster and get back to their daily lives sooner
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
surgical management within 10 days of injury
extraarticular fractures, clinical scissoring
sagittal angulation in accordance with accepted norms (Table 1)
shortening >5mm, translation >50%.
Disqualifiers
< 18 years old
unable to read English, provide consent, or return to follow-up.
Injuries with concomitant soft tissues loss, tendon injury, nerve injury, infection, or fractures with severe comminution
history of prior surgical management of a fracture of the ipsilateral hand
Trial design
Design model
Parallel
Treatments tested in this trial
ORIF
Procedure/SurgeryOpen Reduction and Internal Fixation
IMSF
Procedure/SurgeryIntramedullary Screw Fixation
CRPP
Procedure/SurgeryClosed Reduction and Percutaneous Pinning
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: Open Reduction and Internal FixationExperimental treatment 1 intervention
Group B: Closed Reduction and Percutaneous PinningExperimental treatment 1 intervention
Group C: Intramedullary Screw FixationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Range of Motion
Measure and compare Range of Motion pre and post operatively
Time frame
from enrollment to the of end of the study at 12 months2
Grip strength
Measure and compare grip strength, in Kilograms, pre and post operatively
Time frame
from enrollment to the of end of the study at 12 months3
Visual Analogue Scale for pain
The Visual Analog Scale (VAS) for pain is a standardized, subjective tool used to measure pain intensity. It consists of a straight 10-cm (100-mm) horizontal line anchored at one end by "no pain" and at the other by "the worst pain imaginable." Measure and compare patient reported VAS pre and post operatively.
Time frame
from enrollment to the of end of the study at 12 monthsSecondary outcomes
1
Return to Work
Measure patient reported time to return to work in patients with phalangeal or metacarpal fractures treated with IMSF versus CRPP in phalangeal fractures and IMSF versus ORIF vs CRPP in metacarpal fractures respectively
Time frame
from enrollment to the of end of the study at 12 months2
Complications
Track complications that occur because of IMSF, ORIF, and CRPP in patients with surgically managed metacarpal or phalangeal fractures
Time frame
from enrollment to the of end of the study at 12 months3
Quick Dash,the Quick Disabilities of the Arm, Shoulder, and Hand
The Quick Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire is a validated and widely used 11-item questionnaire that measures upper-extremity specific symptoms and disability. The main DASH uses a 5-point Likert scale (1 = no difficulty, 2 = mild, 3 = moderate, 4 = severe, 5 = unable)
Time frame
from enrollment to the of end of the study at 12 months4
Single assessment numeric evaluation (SANE)
Single assessment numeric evaluation (SANE) score assesses a patient's perceived overall function as a percentage of normal (0% to 100%), with higher scores indicating better function.
Time frame
from enrollment to the of end of the study at 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Spencer B Chambers
Lead sponsor
Western University
Sponsor institution
Source ClinicalTrials.gov
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