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

26. května 2026 aktualizováno: 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

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

100

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Open Reduction and Internal Fixation
patients with metacarpal fractures, we will compare IMSF vs CRPP vs ORIF using a dorsal plate
Postup: ORIF
Open Reduction and Internal Fixation
Ostatní jména:
  • CRPP
Experimentální: 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
Postup: CRPP
Closed Reduction and Percutaneous Pinning
Experimentální: 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
Postup: IMSF
Intramedullary Screw Fixation

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Range of Motion
Časové okno: 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
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Return to Work
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Spencer B Chambers

Vyšetřovatelé

  • Vrchní vyšetřovatel: Spencer B Chambers, Western University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. září 2026

Primární dokončení (Odhadovaný)

1. září 2028

Dokončení studie (Odhadovaný)

1. října 2029

Termíny zápisu do studia

První předloženo

14. května 2026

První předloženo, které splnilo kritéria kontroly kvality

26. května 2026

První zveřejněno (Aktuální)

1. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

1. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

26. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 127846 (Identifikátor registru: University of Western Ontario)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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