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

Not Applicable

Withdrawn

• Conditions: Radius Fracture Distal
• Interventions: Procedure: Wrist joint haematoma washout; Procedure: Volar locking plate insertion of the distal radius

• Registration Number: NCT04135768
• Lead Sponsor: University of Malaya

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.

Study Timeline

• Study First Submitted: 2019-10-20
• Study First Submitted QC: 2019-10-20
• Study First Posted: 2019-10-23
• Study Start: 2019-11-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-14
• Last Update Posted: 2020-07-16
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Volar locking plate insertion of the distal radius	Participants who will undergo both volar locking plate fixation of the distal radius and the study procedure (wrist joint haematoma washout)
Treatment	Wrist joint haematoma washout	Participants who will undergo both volar locking plate fixation of the distal radius and the study procedure (wrist joint haematoma washout)
Placebo	Volar locking plate insertion of the distal radius	Participants who will undergo volar locking plate fixation of the distal radius only

Primary Outcome Measures

Name	Time	Method
Mean difference between QuickDASH scores of both treatment arms at 3 months	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

Name	Time	Method
Mean difference between QuickDASH scores of both treatment arms at 2 weeks, 6 weeks, and 6 months	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 between the visual analogue scores of both groups	2 weeks, 6 weeks, 3 months and 6 months	Visual analogue scores of pain (out of 10). Higher scores indicate more severe pain.
Mean difference between the range of motion of the wrist of both groups	2 weeks, 6 weeks, 3 months and 6 months	Assessing range of motion in flexion, extension, pronation, supination, radial deviation and ulnar deviation
Mean difference between rate of complications of both groups	6 months	Complications such as infection, tendon irritation/rupture/adhesions, complex regional pain syndrome, etc
Mean difference in time to radiographic fracture union of both groups	6 months	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
Mean difference of rate of improvement of QuickDASH scores between groups across 6 months of follow up	6 months	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 grip strength of both groups	2 weeks, 6 weeks, 3 months and 6 months	Grip strength as measured by a Jamar dynamometer, described as a percentage of the uninjured limb

Trial Locations

Locations (1)

University of Malaya Medical Center; 🇲🇾 Kuala Lumpur, Malaysia