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

Intramedullary Screw Fixation Versus Closed Reduction and Percutaneous Pinning With Cast Immobilization in the Treatment of Phalangeal and Metacarpal Fractures: A Randomized Control Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07616947
Acronym
GRIP
Enrollment
100
Registered
2026-06-01
Start date
2026-09-01
Completion date
2029-10-01
Last updated
2026-06-01

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

Conditions

Metacarpal Fracture, Phalanx Fracture

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

Detailed description

Metacarpal and phalangeal fractures are common traumatic injuries of the hand.1 Many can be treated conservatively, but when there is malalignment or instability, operative reduction and stabilization is required.2,3 Closed reduction and percutaneous pinning (CRPP), or open reduction and internal fixation (ORIF) using plates, screws, or wires are common methods of treatment.4-6 Percutaneous fixation allows stabilization of fractures with minimal soft tissue disruption,7-11 and although technically challenging, if successful, secondary complications such as tendon adhesions and abnormal scarring are uncommon.9 Conversely, open methods require broader exposure resulting in swelling and increased risk of scarring9, but facilitates early active motion allowing earlier return to function.3,10 Intramedullary screw fixation (IMSF) is a technique that is gaining popularity12,13 as it maintains the minimally invasive benefits of CRPP while providing stability similar to ORIF.14 In correctly selected fractures, IM screws facilitate early recovery with minimal down time, allowing expedited treatment and less loss of productivity.3,12,13 Investigators believe IM screws have notable advantages compared to CRPP. Allowing earlier rehabilitation, less external immobilization, and earlier functional recovery has potential to improve quality of life and reduce productivity loss. These procedures are used currently within St. Joseph's Health Care London but there is debate regarding there efficacy and specific surgical technique varies amongst practitioners. The comparison comes between the specific surgical intervention, as although some surgeons have rapidly adapted this technique, is efficacy compared to more classic techniques has not been explored using high level studies, leaving its specific utility less clear.

Interventions

PROCEDUREORIF

Open Reduction and Internal Fixation

PROCEDUREIMSF

Intramedullary Screw Fixation

PROCEDURECRPP

Closed Reduction and Percutaneous Pinning

Sponsors

Spencer B Chambers
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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.

Eligibility

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

Inclusion criteria

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%.

Exclusion criteria

* \< 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

Design outcomes

Primary

MeasureTime frameDescription
Range of Motionfrom enrollment to the of end of the study at 12 monthsMeasure and compare Range of Motion pre and post operatively
Grip strengthfrom enrollment to the of end of the study at 12 monthsMeasure and compare grip strength, in Kilograms, pre and post operatively
Visual Analogue Scale for painfrom enrollment to the of end of the study at 12 monthsThe 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.

Secondary

MeasureTime frameDescription
Return to Workfrom enrollment to the of end of the study at 12 monthsMeasure 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
Complicationsfrom enrollment to the of end of the study at 12 monthsTrack complications that occur because of IMSF, ORIF, and CRPP in patients with surgically managed metacarpal or phalangeal fractures
Quick Dash,the Quick Disabilities of the Arm, Shoulder, and Handfrom enrollment to the of end of the study at 12 monthsThe 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)
Single assessment numeric evaluation (SANE)from enrollment to the of end of the study at 12 monthsSingle 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.
EuroQol 5-Dimensional questionnairefrom enrollment to the of end of the study at 12 monthsThe EuroQol 5-Dimensional questionnaire, EQ-5D, is a concise, generic measure of self-reported health which is accompanied by weights reflecting the relative importance to people of different types of health problems. It evaluates five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression on 5 severity levels (no, slight, moderate, severe, and extreme/unable)) and utilizes an EQ VAS (Visual Analogue Scale) that allows patients to rate their overall health between 0 and 100
Patient-Rated Wrist/Hand Evaluationfrom enrollment to the of end of the study at 12 monthsPRW/HE is the Patient-Rated Wrist/Hand Evaluation. The PRW/HE is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. The PRW/HE allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of 2 subscales: Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0 Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0.

Countries

Canada

Contacts

CONTACTKatrina Munro, MHIS
katrina.munro@sjhc.london.on.ca519-646-6100
PRINCIPAL_INVESTIGATORSpencer B Chambers

Western University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 2, 2026