Trials / Withdrawn
WithdrawnNCT04135768
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 Prospective, Randomised Controlled Pilot Trial Of Wrist Joint Haematoma Washout As An Adjunct To Volar Plating In Intra-articular Distal Radius Fractures
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- University of Malaya · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| PROCEDURE | Volar locking plate insertion of the distal radius | An anatomical locking plate is applied to the distal radius fracture using screws |
Timeline
- Start date
- 2019-11-01
- Primary completion
- 2021-03-31
- Completion
- 2021-03-31
- First posted
- 2019-10-23
- Last updated
- 2020-07-16
Locations
1 site across 1 country: Malaysia
Source: ClinicalTrials.gov record NCT04135768. Inclusion in this directory is not an endorsement.