Intramedullary Screw Fixation Versus Closed Reduction and Percutaneous Pinning With Cast Immobilization (GRIP)
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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Katrina Munro, MHIS
- Número de telefone: 64544 519-646-6100
- E-mail: katrina.munro@sjhc.london.on.ca
Locais de estudo
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Ontario
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London, Ontario, Canadá, N6A 4V2
- St. Joseph's Health Care London
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Open Reduction and Internal Fixation
patients with metacarpal fractures, we will compare IMSF vs CRPP vs ORIF using a dorsal plate
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Open Reduction and Internal Fixation
Outros nomes:
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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
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Closed Reduction and Percutaneous Pinning
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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
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Intramedullary Screw Fixation
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Range of Motion
Prazo: from enrollment to the of end of the study at 12 months
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Measure and compare Range of Motion pre and post operatively
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from enrollment to the of end of the study at 12 months
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Grip strength
Prazo: from enrollment to the of end of the study at 12 months
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Measure and compare grip strength, in Kilograms, pre and post operatively
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from enrollment to the of end of the study at 12 months
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Visual Analogue Scale for pain
Prazo: from enrollment to the of end of the study at 12 months
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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.
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from enrollment to the of end of the study at 12 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Return to Work
Prazo: from enrollment to the of end of the study at 12 months
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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
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from enrollment to the of end of the study at 12 months
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Complications
Prazo: from enrollment to the of end of the study at 12 months
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Track complications that occur because of IMSF, ORIF, and CRPP in patients with surgically managed metacarpal or phalangeal fractures
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from enrollment to the of end of the study at 12 months
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Quick Dash,the Quick Disabilities of the Arm, Shoulder, and Hand
Prazo: from enrollment to the of end of the study at 12 months
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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)
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from enrollment to the of end of the study at 12 months
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Single assessment numeric evaluation (SANE)
Prazo: 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.
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from enrollment to the of end of the study at 12 months
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EuroQol 5-Dimensional questionnaire
Prazo: from enrollment to the of end of the study at 12 months
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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
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from enrollment to the of end of the study at 12 months
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Patient-Rated Wrist/Hand Evaluation
Prazo: 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
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Spencer B Chambers, Western University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
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Outros números de identificação do estudo
- 127846 (Identificador de registro: University of Western Ontario)
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