Clinical trial NCT04298385: Traction Orthosis for Oblique Proximal Phalangeal Fractures
Official title: A Non-Invasive and Low-Profile Dynamic Traction Orthosis for Oblique Proximal Phalangeal Fractures: A Case Series
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Trauma
Fractures, Bone
Finger Fracture
Lead sponsor: Southern Health and Social Care Trust
Sponsor class: OTHER_GOV
First posted: 2020-03-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People who have sustained a recent oblique proximal phalanx fractures that is displaced or potentially unstable

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Participants aged 18 years and over who are able to provide informed consent and independently comply with the orthosis and exercise regime
* A recent oblique proximal phalangeal fracture that is displaced or has the potential to become unstable. The decision for trial of a dynamic traction orthosis must be made by the orthopaedic surgeon
* No history of trauma or disease to the affected hand

Exclusion Criteria:

* A fracture which is more than 10 days from injury

  * An open wound around the affected digit
  * A history of allergic reactions to plasters
  * Eczema or dermatitis to the affected hand
  * The presence of sensory loss to the affected digit
  * Ligament or tendon injury that will contra-indicate early mobilisation
  * Transverse proximal phalanx fractures
  * A tattoo to the affected hand that may prevent anonymity when producing photographs

Primary outcomes:
measure: Range of motion
timeFrame: up to three months post intervention
measure: Pain and function
timeFrame: up to three months post intervention
measure: Grip
timeFrame: up to three months post intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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