Back to resultsA 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)
Primary Purpose
Radius Fracture Distal
Status
Withdrawn
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Wrist joint haematoma washout
Volar locking plate insertion of the distal radius
Sponsored by
About this trial
This is an interventional treatment trial for Radius Fracture Distal focused on measuring Distal radius fracture, Articular fracture, Joint haematoma, Volar wrist plating
Eligibility Criteria
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.
Sites / Locations
- University of Malaya Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment
Placebo
Arm Description
Participants who will undergo both volar locking plate fixation of the distal radius and the study procedure (wrist joint haematoma washout)
Participants who will undergo volar locking plate fixation of the distal radius only
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Mean difference between the visual analogue scores of both groups
Visual analogue scores of pain (out of 10). Higher scores indicate more severe pain.
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
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
Mean difference between rate of complications of both groups
Complications such as infection, tendon irritation/rupture/adhesions, complex regional pain syndrome, etc
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04135768
Brief Title
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
Acronym
JWDRF
Official Title
A Prospective, Randomised Controlled Pilot Trial Of Wrist Joint Haematoma Washout As An Adjunct To Volar Plating In Intra-articular Distal Radius Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Withdrawn
Why Stopped
COVID19 pandemic: national lockdown imposed and study centre diverted all trauma cases to surrounding hospitals
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
March 31, 2021 (Anticipated)
Study Completion Date
March 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaya
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radius Fracture Distal
Keywords
Distal radius fracture, Articular fracture, Joint haematoma, Volar wrist plating
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot study, single center, parallel group design
Masking
Participant
Masking Description
Participants are blinded, since the study procedure will be performed via the incision for the main surgery. Thus no external (wound) evidence of the participant's allocation will be visible.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Participants who will undergo both volar locking plate fixation of the distal radius and the study procedure (wrist joint haematoma washout)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants who will undergo volar locking plate fixation of the distal radius only
Intervention Type
Procedure
Intervention Name(s)
Wrist joint haematoma washout
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Volar locking plate insertion of the distal radius
Intervention Description
An anatomical locking plate is applied to the distal radius fracture using screws
Primary Outcome Measure Information:
Title
Mean difference between QuickDASH scores of both treatment arms at 3 months
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Mean difference between QuickDASH scores of both treatment arms at 2 weeks, 6 weeks, and 6 months
Description
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.
Time Frame
2 weeks, 6 weeks and 6 months
Title
Mean difference of rate of improvement of QuickDASH scores between groups across 6 months of follow up
Description
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.
Time Frame
6 months
Title
Mean difference between the visual analogue scores of both groups
Description
Visual analogue scores of pain (out of 10). Higher scores indicate more severe pain.
Time Frame
2 weeks, 6 weeks, 3 months and 6 months
Title
Mean difference between the grip strength of both groups
Description
Grip strength as measured by a Jamar dynamometer, described as a percentage of the uninjured limb
Time Frame
2 weeks, 6 weeks, 3 months and 6 months
Title
Mean difference between the range of motion of the wrist of both groups
Description
Assessing range of motion in flexion, extension, pronation, supination, radial deviation and ulnar deviation
Time Frame
2 weeks, 6 weeks, 3 months and 6 months
Title
Mean difference between rate of complications of both groups
Description
Complications such as infection, tendon irritation/rupture/adhesions, complex regional pain syndrome, etc
Time Frame
6 months
Title
Mean difference in time to radiographic fracture union of both groups
Description
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
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tunku Sara Tunku Ahmad Yahaya, FRCS
Organizational Affiliation
University of Malaya Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Malaya Medical Center
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing 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
Citations:
PubMed Identifier
28991578
Citation
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.
Results Reference
background
PubMed Identifier
14588078
Citation
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.
Results Reference
background
PubMed Identifier
27554281
Citation
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.
Results Reference
background
PubMed Identifier
29228851
Citation
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.
Results Reference
background
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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
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