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

NCT04135768 | Withdrawn

• 1 other identifier: 103
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Radius Fracture Distal

Keywords

Distal radius fracture; Articular fracture; Joint haematoma; Volar wrist plating

Outcome Measures

Primary Outcomes (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.

  3 months

Secondary Outcomes (7)

• Mean difference between QuickDASH scores of both treatment arms at 2 weeks, 6 weeks, and 6 months

  2 weeks, 6 weeks and 6 months

• Mean difference of rate of improvement of QuickDASH scores between groups across 6 months of follow up

  6 months

• Mean difference between the visual analogue scores of both groups

  2 weeks, 6 weeks, 3 months and 6 months

• Mean difference between the grip strength of both groups

  2 weeks, 6 weeks, 3 months and 6 months

• Mean difference between the range of motion of the wrist of both groups

  2 weeks, 6 weeks, 3 months and 6 months

Study Arms (2)

Treatment

EXPERIMENTAL

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; Procedure: Volar locking plate insertion of the distal radius

Placebo

PLACEBO COMPARATOR

Participants who will undergo volar locking plate fixation of the distal radius only

Procedure: Volar locking plate insertion of the distal radius

Interventions

Wrist joint haematoma washout PROCEDURE

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.

Treatment

Volar locking plate insertion of the distal radius PROCEDURE

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

Placebo; Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University of Malaya Medical Center

Kuala Lumpur, 59100, Malaysia

Location

Related 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.

  PMID: 28991578 BACKGROUND

• 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.

  PMID: 14588078 BACKGROUND

• 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.

  PMID: 27554281 BACKGROUND

• 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.

  PMID: 29228851 BACKGROUND

MeSH Terms

Conditions

Wrist Fractures; Intra-Articular Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Tunku Sara Tunku Ahmad Yahaya, FRCS

  University of Malaya Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Trainee

Model Details: Pilot study, single center, parallel group design

Study Record Dates

• First Submitted: October 20, 2019
• First Posted: October 23, 2019
• Study Start: November 1, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: July 16, 2020

Record last verified: 2020-07

Locations

MY (1)