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

Radius Fracture Distal Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04135768
• Other study ID #: 103
• Status: Withdrawn
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: July 2020
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Hematoma
• Radius Fracture Distal
• Radius Fractures

Intervention

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.
• Volar locking plate insertion of the distal radius
An anatomical locking plate is applied to the distal radius fracture using screws

Locations

Country	Name	City	State
Malaysia	University of Malaya Medical Center	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & Publications (4)

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. Review. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Mean difference between rate of complications of both groups	Complications such as infection, tendon irritation/rupture/adhesions, complex regional pain syndrome, etc	6 months
Secondary	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

External Links

•   AAOS Guideline on Distal Radius Fractures