NCT04298385

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

January 30, 2020

Last Update Submit

March 4, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Individuals with oblique proximal phalanx fractures of finger

Traction orthosis and exercise

Other: Traction orthosis

Interventions

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

Also known as: exercise
Individuals with oblique proximal phalanx fractures of finger

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (17)

  • 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.

MeSH Terms

Conditions

Wounds and InjuriesFractures, Bone

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Advanced Occupational Therapist

Study Record Dates

First Submitted

January 30, 2020

First Posted

March 6, 2020

Study Start

March 1, 2020

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

March 6, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share