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

26. Mai 2026 aktualisiert von: Spencer B Chambers

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

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

100

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Kanada
    • Ontario
      • London, Ontario, Kanada, N6A 4V2
        • St. Joseph's Health Care London

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Open Reduction and Internal Fixation
patients with metacarpal fractures, we will compare IMSF vs CRPP vs ORIF using a dorsal plate
Verfahren: ORIF
Open Reduction and Internal Fixation
Andere Namen:
  • CRPP
Experimental: Closed Reduction and Percutaneous Pinning
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
Verfahren: CRPP
Closed Reduction and Percutaneous Pinning
Experimental: Intramedullary Screw Fixation
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
Verfahren: IMSF
Intramedullary Screw Fixation

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Range of Motion
Zeitfenster: from enrollment to the of end of the study at 12 months
Measure and compare Range of Motion pre and post operatively
from enrollment to the of end of the study at 12 months
Grip strength
Zeitfenster: from enrollment to the of end of the study at 12 months
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
Zeitfenster: from enrollment to the of end of the study at 12 months
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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Return to Work
Zeitfenster: from enrollment to the of end of the study at 12 months
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
from enrollment to the of end of the study at 12 months
Complications
Zeitfenster: from enrollment to the of end of the study at 12 months
Track complications that occur because of IMSF, ORIF, and CRPP in patients with surgically managed metacarpal or phalangeal fractures
from enrollment to the of end of the study at 12 months
Quick Dash,the Quick Disabilities of the Arm, Shoulder, and Hand
Zeitfenster: from enrollment to the of end of the study at 12 months
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)
from enrollment to the of end of the study at 12 months
Single assessment numeric evaluation (SANE)
Zeitfenster: from enrollment to the of end of the study at 12 months
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.
from enrollment to the of end of the study at 12 months
EuroQol 5-Dimensional questionnaire
Zeitfenster: from enrollment to the of end of the study at 12 months
The 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
from enrollment to the of end of the study at 12 months
Patient-Rated Wrist/Hand Evaluation
Zeitfenster: from enrollment to the of end of the study at 12 months

PRW/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.
from enrollment to the of end of the study at 12 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Spencer B Chambers

Ermittler

  • Hauptermittler: Spencer B Chambers, Western University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

1. September 2028

Studienabschluss (Geschätzt)

1. Oktober 2029

Studienanmeldedaten

Zuerst eingereicht

14. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. Mai 2026

Zuerst gepostet (Tatsächlich)

1. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

26. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 127846 (Registrierungskennung: University of Western Ontario)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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