A Study Examining The Effect Of Wrist Joint Haematoma Washout As An Adjunct Procedure To Plating Of The Distal Radius In Fractures Of The Distal Radius Involving The Wrist Joint (JWDRF)

A Prospective, Randomised Controlled Pilot Trial Of Wrist Joint Haematoma Washout As An Adjunct To Volar Plating In Intra-articular Distal Radius Fractures

Intra-articular fractures of the distal radius are common in urban populations and result in significant morbidity in terms of time away from work. Volar plating of the distal radius is a commonly used mode of surgical fixation of this fracture. The joint haematoma resulting from the fracture has been hypothesized to contribute to the post-injury disability. As such, this study aims to examine if the evacuation of the haematoma during volar plating results in superior functional outcomes at three months post surgery.

Study Overview

• Status: Withdrawn
• Conditions: Radius Fracture Distal
• Intervention / Treatment: Procedure: Wrist joint haematoma washout; Procedure: Volar locking plate insertion of the distal radius

Detailed Description

Distal radius fractures have an incidence of up to 50% of all fractures, with up to two thirds being intra-articular fractures. While most fractures treated with a variety of methods achieve satisfactory patient reported outcomes at one year post treatment, patients experience pain and functional impairment up to 3 and 6 months post treatment. Open reduction and internal fixation using volar plates is one popular mode of treatment. It is relatively widely available and allows almost immediate post operative mobilisation and rehabilitation.

One theory which could explain the delay in functional recovery is the persistence of the intra-articular haematoma. The evacuation of this haematoma may be partly responsible for the satisfactory results published by authors who perform wrist arthroscopy assisted distal radius fixation.

In our literature review, it is not routine to evacuate this haematoma during conventional volar plating of the distal radius. As such, we aim to study if the evacuation of the haematoma in conjunction with volar plating confers functional benefits in the short term, particularly at 3 months post surgery.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • University of Malaya Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

INCLUSION CRITERIA:

Skeletally mature patients of either sex who sustain closed fractures of the distal end radius involving the articular surface, between the ages of 18 and 65

The fracture pattern is of an unacceptable morphology as defined by the following radiographic parameters according to the 2009 American Academy of Orthopaedic Surgeons (AAOS) Clinical Guidelines (Lichtmann, Bindra et al. 2010):

>3 mm radial shortening >10° dorsal tilt >2 mm articular displacement The patient has been planned to undergo VLPF Femalepatientswilleitherbe Post-menopausal Surgically sterile If of childbearing age, must have a negative urine pregnancy test at screening and at randomisation. Pregnancy tests will be repeated during each visit.

EXCLUSION CRITERIA:

Open fractures Associated fractures around the wrist (e.g. carpal bones, metacarpals, phalanges) requiring different or additional methods of fracture fixation and stabilisation Polytraumatised patients Compartmentsyndromeoftheforearmorhand Neurovascular injury of the ipsilateral limb Concomitantfractureoftheipsilateraland/orcontralateralupperlimbwhichmayimpede post-operative rehabilitation Fractures exceeding 14 days duration during time of first presentation

Pre-existing conditions such as:

Inflammatory arthritides Connective tissue diseases Diseases of bone metabolism (except osteoporosis) Prior malunited/nonunited fractures of the ipsilateral limb Pregnancy Patients unfit for surgery due to poor general condition Inability or unwillingness to provide written consent. Inability or unwillingness to comply with the requirements of the protocol as determined by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Participants who will undergo both volar locking plate fixation of the distal radius and the study procedure (wrist joint haematoma washout)	Procedure: Wrist joint haematoma washout; After plating of the distal radius is performed, a small incision is made on the wrist joint capsule. This is the portal for fluid efflux. An intravenous cannula is used to puncture the wrist joint capsule adjacent to the first incision and normal saline is infused through this cannula into the wrist joint. The infusion continues until the fluid efflux from the first portal is clear and no longer blood stained. This will be the point at which the washout is considered to be complete.; Procedure: Volar locking plate insertion of the distal radius; An anatomical locking plate is applied to the distal radius fracture using screws
Placebo Comparator: Placebo; Participants who will undergo volar locking plate fixation of the distal radius only	Procedure: Volar locking plate insertion of the distal radius; An anatomical locking plate is applied to the distal radius fracture using screws

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean difference between QuickDASH scores of both treatment arms at 3 months	A patient reported outcome using the QuickDASH (Quick Disabilities of the Arm, Shoulder and Hand) score. This is a patient reported outcome score, which consists of 11 questions. A minimum of 10 must be answered for the score to be valid. The score out of 11 is then calculated as a percentage, with higher numbers indicating worse disability.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean difference between QuickDASH scores of both treatment arms at 2 weeks, 6 weeks, and 6 months	Comparing patient reported outcomes at other points of time in follow up. This is a patient reported outcome score, which consists of 11 questions. A minimum of 10 must be answered for the score to be valid. The score out of 11 is then calculated as a percentage, with higher numbers indicating worse disability.	2 weeks, 6 weeks and 6 months
Mean difference of rate of improvement of QuickDASH scores between groups across 6 months of follow up	Assessing difference in rate of change of the QuickDASH score over time.This is a patient reported outcome score, which consists of 11 questions. A minimum of 10 must be answered for the score to be valid. The score out of 11 is then calculated as a percentage, with higher numbers indicating worse disability.	6 months
Mean difference between the visual analogue scores of both groups	Visual analogue scores of pain (out of 10). Higher scores indicate more severe pain.	2 weeks, 6 weeks, 3 months and 6 months
Mean difference between the grip strength of both groups	Grip strength as measured by a Jamar dynamometer, described as a percentage of the uninjured limb	2 weeks, 6 weeks, 3 months and 6 months
Mean difference between the range of motion of the wrist of both groups	Assessing range of motion in flexion, extension, pronation, supination, radial deviation and ulnar deviation	2 weeks, 6 weeks, 3 months and 6 months
Mean difference between rate of complications of both groups	Complications such as infection, tendon irritation/rupture/adhesions, complex regional pain syndrome, etc	6 months
Mean difference in time to radiographic fracture union of both groups	Assessing X rays at follow up to determine radiographically that the fracture is united. This is determined as the point at which at least 3 out of 4 cortices of the fracture are bridged with callus on two orthogonal X ray views of the wrist	6 months

Collaborators and Investigators

• Sponsor: University of Malaya
• Investigators: Study Chair: Tunku Sara Tunku Ahmad Yahaya, FRCS, University of Malaya Medical Center

Publications and helpful links

General Publications

• Smeraglia F, Del Buono A, Maffulli N. Wrist arthroscopy in the management of articular distal radius fractures. Br Med Bull. 2016 Sep;119(1):157-65. doi: 10.1093/bmb/ldw032. Epub 2016 Aug 22.
• Abe Y, Fujii K. Arthroscopic-Assisted Reduction of Intra-articular Distal Radius Fracture. Hand Clin. 2017 Nov;33(4):659-668. doi: 10.1016/j.hcl.2017.07.011.
• MacDermid JC, Roth JH, Richards RS. Pain and disability reported in the year following a distal radius fracture: a cohort study. BMC Musculoskelet Disord. 2003 Oct 31;4:24. doi: 10.1186/1471-2474-4-24.
• Gouk CJC, Bindra RR, Tarrant DJ, Thomas MJE. Volar locking plate fixation versus external fixation of distal radius fractures: a meta-analysis. J Hand Surg Eur Vol. 2018 Nov;43(9):954-960. doi: 10.1177/1753193417743936. Epub 2017 Dec 11.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Anticipated): March 31, 2021
• Study Completion (Anticipated): March 31, 2021

Study Registration Dates

• First Submitted: October 20, 2019
• First Submitted That Met QC Criteria: October 20, 2019
• First Posted (Actual): October 23, 2019

Study Record Updates

• Last Update Posted (Actual): July 16, 2020
• Last Update Submitted That Met QC Criteria: July 14, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Distal radius fracture; Articular fracture; Joint haematoma; Volar wrist plating
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Hemorrhage; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures; Hematoma
• Other Study ID Numbers: 103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Participant results only will be made available to other researchers from University of Malaya should a related study be conducted. Identifying data will not be shared. Participants will be identified by subject ID only

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No