Traction Orthosis for Oblique Proximal Phalangeal Fractures

Trauma Clinical Trial

Official title:

A Non-Invasive and Low-Profile Dynamic Traction Orthosis for Oblique Proximal Phalangeal Fractures: A Case Series

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04298385
• Other study ID #: V4 20012020
• Status: Not yet recruiting
• Start date: March 2020
• Est. completion date: August 2020

Study information

• Verified date: March 2020
• Source: Southern Health and Social Care Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Finger Fracture
• Fractures, Bone
• Trauma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Southern Health and Social Care Trust

References & Publications (17)

Baier S, Szekeres M. The hand arc--a hand-based splint design for intraarticular fractures. J Hand Ther. 2010 Jan-Mar;23(1):73-76. doi: 10.1016/j.jht.2009.07.006. Epub 2009 Nov 1. — View Citation

Byrne A, Yau T. A modified dynamic traction splint for unstable intra-articular fractures of the proximal interphalangeal joint. J Hand Ther. 1995 Jul-Sep;8(3):216-8. — View Citation

Chinchalkar SJ, Gan BS. Management of proximal interphalangeal joint fractures and dislocations. J Hand Ther. 2003 Apr-Jun;16(2):117-28. Review. — View Citation

Collins AL, Timlin M, Thornes B, O'Sullivan T. Old principles revisited--traction splinting for closed proximal phalangeal fractures. Injury. 2002 Apr;33(3):235-7. — View Citation

Feehan LM, Bassett K. Is there evidence for early mobilization following an extraarticular hand fracture? J Hand Ther. 2004 Apr-Jun;17(2):300-8. Review. — View Citation

Fitzgerald JA, Khan MA. The conservative management of fractures of the shafts of the phalanges of the fingers by combined traction-splintage. J Hand Surg Br. 1984 Oct;9(3):303-6. — View Citation

Goldman SB, Amaker RJ, Espinosa RA. James traction splinting for PIP fractures. J Hand Ther. 2008 Apr-Jun;21(2):209-15. doi: 10.1197/j.jht.2007.08.019. — View Citation

Hardy MA. Principles of metacarpal and phalangeal fracture management: a review of rehabilitation concepts. J Orthop Sports Phys Ther. 2004 Dec;34(12):781-99. Review. — View Citation

Jehan S, Chandraprakasam T, Thambiraj S. Management of proximal phalangeal fractures of the hand using finger nail traction and a digital splint: a prospective study of 43 cases. Clin Orthop Surg. 2012 Jun;4(2):156-62. doi: 10.4055/cios.2012.4.2.156. Epub — View Citation

Kadelbach D. Swing design dynamic traction splinting for the treatment of intra-articular fractures of the digits. J Hand Ther. 2006 Jan-Mar;19(1):39-42. — View Citation

Mathiowetz V, Kashman N, Volland G, Weber K, Dowe M, Rogers S. Grip and pinch strength: normative data for adults. Arch Phys Med Rehabil. 1985 Feb;66(2):69-74. — View Citation

Miller L, Ada L, Crosbie J, Wajon A. Pattern of recovery after open reduction and internal fixation of proximal phalangeal fractures in the finger: a prospective longitudinal study. J Hand Surg Eur Vol. 2017 Feb;42(2):137-143. doi: 10.1177/175319341667059 — View Citation

Murray KA, McIntyre FH. Active traction splinting for proximal interphalangeal joint injuries. Ann Plast Surg. 1995 Jul;35(1):15-8. — View Citation

O'Brien L, Presnell S. Patient experience of distraction splinting for complex finger fracture dislocations. J Hand Ther. 2010 Jul-Sep;23(3):249-9; quiz 260. doi: 10.1016/j.jht.2010.01.002. — View Citation

Packham TL, Ball PD, MacDermid JC, Bain JR, DalCin A. A scoping review of applications and outcomes of traction orthoses and constructs for the management of intra-articular fractures and fracture dislocations in the hand. J Hand Ther. 2016 Jul-Sep;29(3): — View Citation

Schenck RR. Dynamic traction and early passive movement for fractures of the proximal interphalangeal joint. J Hand Surg Am. 1986 Nov;11(6):850-8. — View Citation

Spurrier E, Pathak G, Khanna A. Pressure exerted by finger traps. J Perioper Pract. 2011 Apr;21(4):140-1. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of motion	Goniometer: Measures in degrees range of movement of a joint	up to three months post intervention
Primary	Pain and function	Patient Related Wrist Hand Evaluation: a Likert scale that measure pain and function on a total score of 0-100	up to three months post intervention
Primary	Grip	Dynamometer: measure hand grip in Ibs and can be compared to normative data	up to three months post intervention