Clinical Trials Directory

Trials / Completed

CompletedNCT02536157

Volar Plate Injury: A Comparison of Two Splinting Methods

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
42 (actual)
Sponsor
National Health Service, United Kingdom · Other Government
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEThermoplastic splinting

Timeline

Start date
2015-07-01
Primary completion
2017-01-01
Completion
2017-01-01
First posted
2015-08-31
Last updated
2019-03-21

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT02536157. Inclusion in this directory is not an endorsement.