Traction Orthosis for Oblique Proximal Phalangeal Fractures

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.

Study Overview

• Status: Unknown
• Conditions: Fractures, Bone; Trauma; Finger Fracture
• Intervention / Treatment: Other: Traction orthosis

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

• Study Type: Observational
• Enrollment (Anticipated): 10

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

People who have sustained a recent oblique proximal phalanx fractures that is displaced or potentially unstable

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Individuals with oblique proximal phalanx fractures of finger; Traction orthosis and exercise	Other: Traction orthosis; Traction applied to a finger using elastic thread and sports tape and attached to an orthosis; Other Names: exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of motion	Goniometer: Measures in degrees range of movement of a joint	up to three months post intervention
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
Grip	Dynamometer: measure hand grip in Ibs and can be compared to normative data	up to three months post intervention

Collaborators and Investigators

• Sponsor: Southern Health and Social Care Trust

Publications and helpful links

General Publications

• 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. doi: 10.1016/s0363-5023(86)80236-2.
• 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. doi: 10.1016/s0020-1383(01)00138-3.
• 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. doi: 10.1016/0266-7681(84)90048-2.
• 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.
• 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 2012 May 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.
• 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. doi: 10.1016/s0894-1130(12)80022-6. No abstract available.
• 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. doi: 10.1197/j.jht.2005.11.001.
• Murray KA, McIntyre FH. Active traction splinting for proximal interphalangeal joint injuries. Ann Plast Surg. 1995 Jul;35(1):15-8. doi: 10.1097/00000637-199507000-00003.
• 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. doi: 10.2519/jospt.2004.34.12.781.
• 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. doi: 10.1197/j.jht.2004.02.014.
• Chinchalkar SJ, Gan BS. Management of proximal interphalangeal joint fractures and dislocations. J Hand Ther. 2003 Apr-Jun;16(2):117-28. doi: 10.1016/s0894-1130(03)80007-8.
• 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: 10.1177/1753193416670591. Epub 2016 Oct 4.
• 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.
• 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):246-68. doi: 10.1016/j.jht.2016.04.001.
• Spurrier E, Pathak G, Khanna A. Pressure exerted by finger traps. J Perioper Pract. 2011 Apr;21(4):140-1. doi: 10.1177/175045891102100405.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2020
• Primary Completion (ANTICIPATED): August 1, 2020
• Study Completion (ANTICIPATED): August 1, 2020

Study Registration Dates

• First Submitted: January 30, 2020
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (ACTUAL): March 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 6, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: V4 20012020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No