TraumaNCT04298385
Traction Orthosis for Oblique Proximal Phalangeal Fractures
An observational study of Trauma and Fractures, Bone, run by Southern Health and Social Care Trust.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Fractures, Bone, Finger Fracture
- What is being tested?
- Traction orthosis
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: People who have sustained a recent oblique proximal phalanx fractures that is displaced or potentially unstable
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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
- Being tested
- Traction orthosis
- Medical subject headings
- Wounds and Injuries, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traction orthosisOther
Also called exercise
Traction applied to a finger using elastic thread and sports tape and attached to an orthosis
| Study group | Role | What they receive |
|---|---|---|
| Individuals with oblique proximal phalanx fractures of finger | Traction orthosis and exercise Receives: Other: Traction orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion
Goniometer: Measures in degrees range of movement of a joint
Measured: 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
Measured: up to three months post intervention
Grip
Dynamometer: measure hand grip in Ibs and can be compared to normative data
Measured: up to three months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study startMar 2020 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern Health and Social Care Trust
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Daniel Harte, Southern Health and Social Care Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298385
- Sponsor's protocol ID
- V4 20012020
- Status last verified
- Mar 2020
- First submitted
- 30 Jan 2020
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 3794242Collins 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.
PubMed 12084639Fitzgerald 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.
PubMed 6512368Goldman 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.
PubMed 18436143Jehan 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.
PubMed 22662302Baier 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.
PubMed 19883994Byrne 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.
PubMed 8535487Kadelbach 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.
PubMed 16473733Murray 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.
PubMed 7574279Hardy 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.
PubMed 15643733Feehan 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.
PubMed 15162112Chinchalkar 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.
PubMed 12755163Miller 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.
PubMed 27702779O'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.
PubMed 20399606Packham 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.
PubMed 27496982
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Invasive and Low-Profile Dynamic Traction Orthosis for Oblique Proximal Phalangeal Fractures: A Case Series
- ClinicalTrials.gov ID
- NCT04298385
- Acronym / sponsor ID
- V4 20012020
- Conditions
- Trauma, Fractures, Bone, Finger Fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Southern Health and Social Care TrustOther government
- Study start
- Mar 2020 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 6 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with oblique proximal phalanx fractures of finger | – | Other: Traction orthosisTraction orthosis and exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- People who have sustained a recent oblique proximal phalanx fractures that is displaced or potentially unstable
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- A fracture which is more than 10 days from injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traction orthosisAlso: exerciseTraction applied to a finger using elastic thread and sports tape and attached to an orthosis | Other | Individuals with oblique proximal phalanx fractures of finger |
Primary outcome
Range of motion
Time frame: up to three months post intervention
Goniometer: Measures in degrees range of movement of a joint
Pain and function
Time frame: up to three months post intervention
Patient Related Wrist Hand Evaluation: a Likert scale that measure pain and function on a total score of 0-100
Grip
Time frame: up to three months post intervention
Dynamometer: measure hand grip in Ibs and can be compared to normative data
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Results publication: PubMed 3794242Schenck 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.
- Results publication: PubMed 12084639Collins 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.
- Results publication: PubMed 6512368Fitzgerald 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.
- Results publication: PubMed 18436143Goldman 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.
- Results publication: PubMed 22662302Jehan 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.
- Results publication: PubMed 19883994Baier 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.
- Results publication: PubMed 8535487Byrne 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.
- Results publication: PubMed 16473733Kadelbach 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.
- Results publication: PubMed 7574279Murray 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.
- Results publication: PubMed 15643733Hardy 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.
- Results publication: PubMed 15162112Feehan 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.
- Results publication: PubMed 12755163Chinchalkar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma and Fractures, Bone, run by Southern Health and Social Care Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion (time frame: up to three months post intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04298385, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.