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Volar Plate Injury: A Comparison of Two Splinting Methods

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02536157
Recruitment Status : Completed
First Posted : August 31, 2015
Last Update Posted : March 21, 2019
Sponsor:
Collaborator:
University of Bradford
Information provided by (Responsible Party):
Claire Paxman, National Health Service, United Kingdom

Tracking Information
First Submitted Date  ICMJE August 21, 2015
First Posted Date  ICMJE August 31, 2015
Last Update Posted Date March 21, 2019
Actual Study Start Date  ICMJE July 2015
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2015)
  • Range of movement measured with a Jamar finger goniometer. [ Time Frame: One week ]
    Range of movement measured with a Jamar finger goniometer.
  • Range of movement measured with a Jamar finger goniometer. [ Time Frame: Four weeks ]
    Range of movement measured with a Jamar finger goniometer.
  • Range of movement measured with a Jamar finger goniometer. [ Time Frame: Twelve weeks ]
    Range of movement measured with a Jamar finger goniometer.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2015)
  • Pain measured using a 100mm visual analogue scale. [ Time Frame: One, four and twelve weeks ]
    Measured using a 100mm visual analogue scale.
  • Function of the upper limb measured using the DASH questionnaire. [ Time Frame: One, four and twelve weeks ]
    Disabilities of the Shoulder, Arm and Hand Questionnaire.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Volar Plate Injury: A Comparison of Two Splinting Methods
Official Title  ICMJE A Randomised Controlled Trial Investigating the Effectiveness of Two Splinting Methods in the Non-operative Management of Volar Plate Injuries at the Proximal Interphalangeal Joint
Brief Summary

Which splinting method produces the best outcomes (in range of movement, pain and function) in the non-operative treatment of stable volar plate injuries in adults?

The volar plate is a ligament located at the middle knuckle (proximal interphalangeal joint - PIPJ) of the finger. It is commonly injured through hyperextension, for example a ball hitting the fingertip. Current treatment in the Hand Therapy Unit involves splinting the injured joint dorsally (on the back of the finger) into 20⁰ flexion (bent) using thermoplastic material. However, there is a potential risk of developing permanent stiffness of the PIPJ into straightening, once the volar plate ligament heals. To reduce this risk, the study aims to investigate if using a volar (on the front of the finger) gutter splint in 0⁰ flexion (straight), which still prevents hyperextension, achieves better outcomes. There is no existing high-quality evidence comparing these two methods.

This is a randomised controlled trial. For the purposes of this study, the current treatment of a 20° dorsal block splint will act as the control group. The intervention group will be the volar gutter splint group. A convenience sample will be used and all patients (over 16 years old) presenting to the Mid Yorkshire Hospitals NHS Trust's Hand Therapy Unit will be invited to participate in the study, with consideration to inclusion/exclusion criteria. Participants will be randomised into one of two groups through the use of a random number generator. The outcomes assessed will be range of movement, pain and function. These will be measured at initial assessment, four and twelve weeks. These are all average normal time intervals that patients are seen. Each splint is worn for four weeks and participants will receive standardised advice, exercises and treatment.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Volar Plate Injury of the Proximal Interphalangeal Joint
Intervention  ICMJE Device: Thermoplastic splinting
Study Arms  ICMJE
  • Active Comparator: Dorsal block splint
    Thermoplastic splint in 20 degrees flexion applied to the dorsum of the PIPJ.
    Intervention: Device: Thermoplastic splinting
  • Experimental: Volar gutter splint
    Thermoplastic splint in 0 degrees flexion applied to the volar surface of the finger.
    Intervention: Device: Thermoplastic splinting
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 26, 2015)
42
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. All stable volar plate injuries.
  2. Aged 16 and older.
  3. Male and female.
  4. Acute presentation within 2 weeks of injury.
  5. All ethnic groups speaking English.

Exclusion Criteria:

  1. Vulnerable patient groups or those lacking capacity.
  2. Previous injury or pathology involving the same digit.
  3. Surgical intervention
  4. Unstable proximal interphalangeal joint.
  5. Concomitant tendon or additional bony injury outside the traditional Eaton classification types of volar plate injury.
  6. The DASH outcome measure is available and validated in 27 languages. However, those who do not speak/understand English well will unfortunately be excluded. This is an educational project and therefore there is no funding to use a translator service.
  7. Volar plate injuries are just as common in children and teenagers as adults. But under 16s will be excluded from this study as the DASH questionnaire has only been assumed valid in adults. There is no research investigating its use in younger age-groups.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02536157
Other Study ID Numbers  ICMJE 12020625
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Claire Paxman, National Health Service, United Kingdom
Study Sponsor  ICMJE National Health Service, United Kingdom
Collaborators  ICMJE University of Bradford
Investigators  ICMJE Not Provided
PRS Account National Health Service, United Kingdom
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP