Trauma Clinical Trial
Official title:
A Non-Invasive and Low-Profile Dynamic Traction Orthosis for Oblique Proximal Phalangeal Fractures: A Case Series
The term Ligamentotaxis is used to define the method of distal traction to realign joint
surfaces and reduce articular fragments after complex fractures.
Traction and mobilization can be combined to help deliver the best outcome.
This study will present a dynamic traction orthosis design with the aim that it is
easy-to-make, non-invasive, low-profile and allow for ease in performing active and passive
exercises. The clinical effectiveness of this method will be examined by analyzing treatment
outcomes in a case series cohort.
The term Ligamentotaxis is used to define the method of distal traction to realign joint
surfaces and reduce articular fragments after complex fractures. In the management of complex
finger fractures, ligamentotaxis has been used to favourably help fracture alignment and
reduction, range of movement (ROM), pain, grip and function. Traction has been applied via
nail anchors skin traction and Kirschner wires.
Phalangeal fractures are at risk of chronic stiffness when immobilised. Early mobilization
seeks to achieve the best outcome for the patient as it will aid healing, promote cartilage
regeneration, help prevent adhesions and optimize range of movement. Mobilisation of
phalangeal fractures as soon as possible after open reduction internal fixation has shown to
produce greater total range of movement at six weeks post-operatively. Traction and
mobilization can be combined to help deliver the best outcome however dynamic traction
orthoses tend to be "high-profile". This can cause difficulties in activities of daily living
and can be perceived negatively by users. Most dynamic traction orthoses use Kirschner wires
which have the potential complication of loosening and pin site infection.
Two methods report good outcomes using the less invasive and less expensive means of tape and
nail traction respectively. The Early Active Vector Adjustable Skin Traction (EAVAST)
orthosis has no reported issues using adhesive tape though the patient is required to remove
the orthosis to perform exercises. This removes any stability offered by the orthosis during
the early phases of healing. The Poole traction orthosis is well-established in some centres
with reported good outcomes however nail traction has the potential complication of nail bed
haematoma or nail avulsion.
A recent orthosis design by the Chief Investigator aspired to be non-invasive, low-profile
and allow for ease when performing exercises. However, this design may be deemed too time
consuming to make, particularly for the inexperienced therapist in a busy clinic. This study
will present a further iteration of the dynamic traction orthosis with the aim that it is
easy-to-make, non-invasive, low-profile and allow for ease in performing active and passive
exercises. The clinical effectiveness of this method will be examined by analyzing treatment
outcomes in a case series cohort.
The new orthosis design will be easy to fabricate and can be produced with common materials
and tools in a hand therapy clinic. It offers a non-invasive approach to dynamic traction and
simultaneously is easy to perform a variety of tendon glides and active and passive
exercises. It also reduces the risk associated with nail traction and pinning. It is
low-profile ensuring range of motion is maintained in non-affected joints and helps
participation in activities of daily living. The proposed case series will illustrate this
method and explore its clinical application by presenting outcomes.
Though a recent scoping review reports that research addressing traction orthoses and
constructs consists of primarily low-quality studies and no consensus on the their effect on
different fracture classifications, this small study will act as a feasibility study to
assess the orthosis design with a focus on displaced oblique proximal phalangeal fractures or
potentially unstable oblique proximally phalangeal fractures
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04848376 -
Post-Market Clinical Follow-up Study of A-SPINE's Products
|
||
| Terminated |
NCT03781817 -
Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures
|
Phase 4 | |
| Completed |
NCT04342416 -
Using a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women
|
N/A | |
| Recruiting |
NCT04856449 -
DBT Skills Plus EMDR for BPD and Trauma
|
N/A | |
| Completed |
NCT04356963 -
Adjunct VR Pain Management in Acute Brain Injury
|
N/A | |
| Completed |
NCT05669313 -
The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
|
||
| Active, not recruiting |
NCT03622632 -
Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
|
||
| Recruiting |
NCT04725721 -
Testing FIRST in Youth Outpatient Psychotherapy
|
N/A | |
| Active, not recruiting |
NCT05530642 -
An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel
|
N/A | |
| Not yet recruiting |
NCT05649891 -
Checklists Resuscitation Emergency Department
|
N/A | |
| Not yet recruiting |
NCT03696563 -
FreeO2 PreHospital - Automated Oxygen Titration vs Manual Titration According to the BLS-PCS
|
N/A | |
| Withdrawn |
NCT03249129 -
Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma
|
||
| Completed |
NCT02240732 -
Surgical Tourniquets and Cerebral Emboli
|
N/A | |
| Completed |
NCT02227979 -
Effects of PURPLE Cry Intervention
|
N/A | |
| Withdrawn |
NCT01169025 -
Fentanyl vs. Low-Dose Ketamine for the Relief of Moderate to Severe Pain in Aeromedical Patients
|
N/A | |
| Recruiting |
NCT01812941 -
Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients
|
N/A | |
| Completed |
NCT03112304 -
Child STEPS for Youth Mental Health in Maine Sustainability
|
N/A | |
| Completed |
NCT01475344 -
Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC)
|
Phase 1/Phase 2 | |
| Completed |
NCT01201863 -
Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy
|
Phase 4 | |
| Completed |
NCT01210417 -
Trauma Heart to Arm Time
|
N/A |