Traction Orthosis for Oblique Proximal Phalangeal Fractures

NCT ID: NCT04298385

Last Updated: 2020-03-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-31
• Study Completion Date: 2020-08-31

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

Conditions

Trauma; Fractures, Bone; Finger Fracture

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Individuals with oblique proximal phalanx fractures of finger

Traction orthosis and exercise

Traction orthosis

Intervention Type: OTHER

Traction applied to a finger using elastic thread and sports tape and attached to an orthosis

Interventions

Traction orthosis

Traction applied to a finger using elastic thread and sports tape and attached to an orthosis

Intervention Type: OTHER

Other Intervention Names

exercise

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southern Health and Social Care Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Daniel Harte

Advanced Occupational Therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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Other Identifiers

V4 20012020

Identifier Type: -

Identifier Source: org_study_id