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

26 maggio 2026 aggiornato da: 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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

100

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Open Reduction and Internal Fixation
patients with metacarpal fractures, we will compare IMSF vs CRPP vs ORIF using a dorsal plate
Procedura: ORIF
Open Reduction and Internal Fixation
Altri nomi:
  • CRPP
Sperimentale: 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
Procedura: CRPP
Closed Reduction and Percutaneous Pinning
Sperimentale: 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
Procedura: IMSF
Intramedullary Screw Fixation

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Range of Motion
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Return to Work
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Spencer B Chambers

Investigatori

  • Investigatore principale: Spencer B Chambers, Western University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 settembre 2028

Completamento dello studio (Stimato)

1 ottobre 2029

Date di iscrizione allo studio

Primo inviato

14 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

26 maggio 2026

Primo Inserito (Effettivo)

1 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 127846 (Identificatore di registro: University of Western Ontario)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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