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AzTrials

Radius Fracture DistalJWDRFNCT04135768

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

A study testing Wrist joint haematoma washout and Volar locking plate insertion of the distal radius in people with Radius Fracture Distal, run by University of Malaya at 1 site in Malaysia.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Radius Fracture Distal
What is being tested?
Wrist joint haematoma washout and Volar locking plate insertion of the distal radius
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteMalaysia
Study dates
1 Nov 2019to 31 Mar 2021
Phase
Interventional
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

  • University of Malaya Medical Center

    Kuala Lumpur, 59100

Other trials in Malaysia

About this study

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

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.

Read the 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.

Being tested
Wrist joint haematoma washout, Volar locking plate insertion of the distal radius
Keywords
Distal radius fracture, Articular fracture, Joint haematoma, Volar wrist plating
Medical subject headings
Wrist Fractures, Intra-Articular Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wrist joint haematoma washoutProcedure or surgery

    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.

  • Volar locking plate insertion of the distal radiusProcedure or surgery

    An anatomical locking plate is applied to the distal radius fracture using screws

Study groups in NCT04135768
Study groupRoleWhat they receive
TreatmentExperimentalParticipants who will undergo both volar locking plate fixation of the distal radius and the study procedure (wrist joint haematoma washout)
Receives: Procedure: Wrist joint haematoma washout; Procedure: Volar locking plate insertion of the distal radius
PlaceboPlacebo comparatorParticipants who will undergo volar locking plate fixation of the distal radius only
Receives: Procedure: Volar locking plate insertion of the distal radius

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months

Secondary outcomes (7)

  1. 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.

    Measured: 2 weeks, 6 weeks and 6 months

  2. 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.

    Measured: 6 months

  3. Mean difference between the visual analogue scores of both groups

    Visual analogue scores of pain (out of 10). Higher scores indicate more severe pain.

    Measured: 2 weeks, 6 weeks, 3 months and 6 months

  4. 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

    Measured: 2 weeks, 6 weeks, 3 months and 6 months

  5. 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

    Measured: 2 weeks, 6 weeks, 3 months and 6 months

  6. Mean difference between rate of complications of both groups

    Complications such as infection, tendon irritation/rupture/adhesions, complex regional pain syndrome, etc

    Measured: 6 months

  7. 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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2019
  2. Study start1 Nov 2019
  3. Primary completion31 Mar 2021 (estimated)
  4. Study completion31 Mar 2021 (estimated)

Why it stopped: COVID19 pandemic: national lockdown imposed and study centre diverted all trauma cases to surrounding hospitals

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Pilot study, single center, parallel group design
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04135768
Sponsor's protocol ID
103
Acronym
JWDRF
Status last verified
Jul 2020
First submitted
20 Oct 2019
Last updated
16 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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

Publications

  • 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.

    PubMed 28991578

  • 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.

    PubMed 14588078

  • 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.

    PubMed 27554281

  • 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.

    PubMed 29228851

Questions about this trial

What is this clinical trial studying?

A study testing Wrist joint haematoma washout and Volar locking plate insertion of the distal radius in people with Radius Fracture Distal, run by University of Malaya at 1 site in Malaysia.

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 3 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: withdrawn, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Mean difference between QuickDASH scores of both treatment arms at 3 months (time frame: 3 months). 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 NCT04135768, which also lists 4 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 16 Jul 2020.

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