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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Radius Fracture Distal

Intervention / Treatment
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* Procedure: Wrist joint haematoma washout
* Procedure: Volar locking plate insertion of the distal radius


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pilot study, single center, parallel group design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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<br>* 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.<br>Procedure: Volar locking plate insertion of the distal radius<br>* An anatomical locking plate is applied to the distal radius fracture using screws<br>|
| Placebo Comparator: Placebo<br>Participants who will undergo volar locking plate fixation of the distal radius only | Procedure: Volar locking plate insertion of the distal radius<br>* An anatomical locking plate is applied to the distal radius fracture using screws<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Distal radius fracture, Articular fracture, Joint haematoma, Volar wrist plating