Intramedullary Screw Fixation Versus Closed Reduction and Percutaneous Pinning With Cast Immobilization

NCT07616947 | Not Yet Recruiting

• 1 other identifier: 127846
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metacarpal Fracture; Phalanx Fracture

Outcome Measures

Primary Outcomes (3)

• Range of Motion

  Measure and compare Range of Motion pre and post operatively

  from enrollment to the of end of the study at 12 months

• Grip strength

  Measure and compare grip strength, in Kilograms, pre and post operatively

  from enrollment to the of end of the study at 12 months

• 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.

  from enrollment to the of end of the study at 12 months

Secondary Outcomes (6)

• Return to Work

  from enrollment to the of end of the study at 12 months

• Complications

  from enrollment to the of end of the study at 12 months

• Quick Dash,the Quick Disabilities of the Arm, Shoulder, and Hand

  from enrollment to the of end of the study at 12 months

• Single assessment numeric evaluation (SANE)

  from enrollment to the of end of the study at 12 months

• EuroQol 5-Dimensional questionnaire

  from enrollment to the of end of the study at 12 months

Study Arms (3)

Open Reduction and Internal Fixation

EXPERIMENTAL

patients with metacarpal fractures, we will compare IMSF vs CRPP vs ORIF using a dorsal plate

Procedure: ORIF

Closed Reduction and Percutaneous Pinning

EXPERIMENTAL

we will compare proximal or middle phalangeal fractures treated with IMSF to those treated with CRPP patients with metacarpal fractures, we will compare IMSF vs CRPP vs ORIF using a dorsal plate

Procedure: CRPP

Intramedullary Screw Fixation

EXPERIMENTAL

we will compare proximal or middle phalangeal fractures treated with IMSF to those treated with CRPP patients with metacarpal fractures, we will compare IMSF vs CRPP vs ORIF using a dorsal plate

Procedure: IMSF

Interventions

ORIF PROCEDURE

Open Reduction and Internal Fixation

Also known as: CRPP

Open Reduction and Internal Fixation

IMSF PROCEDURE

Intramedullary Screw Fixation

Intramedullary Screw Fixation

CRPP PROCEDURE

Closed Reduction and Percutaneous Pinning

Closed Reduction and Percutaneous Pinning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The MC arm:
• surgical management within 10 days of injury
• extraarticular fractures, clinical scissoring
• sagittal angulation in accordance with accepted norms (Table 1)
• shortening \>5mm, translation \>50%.
• The phalangeal arm:
• surgical management within 10 days of injury
• extraarticular fractures, clinical scissoring
• sagittal angulation \>20°
• shortening \>2mm
• translation \>50%.

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Spencer B Chambers: lead

Study Sites (1)

St. Joseph's Health Care London

London, Ontario, N6A 4V2, Canada

Location

Study Officials

• Spencer B Chambers

  Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katrina Munro, MHIS

CONTACT

519-646-6100; katrina.munro@sjhc.london.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Surgeon, Assistant Professor

Model Details: Patients will be stratified based on fracture, metacarpals or phalanges. For the metacarpal group, we will use a1:1:1 randomization ratio (ORIF vs CRPP vs IMSF) using blocks of 9. For the phalangeal group, we will use a 1:1 ratio (CRPP vs IMSF) in blocks of 8.

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: June 1, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)