Home » Trials » SLCTR/2017/009
Non-randomized controlled trial on the stability and outcome of the conventional wrist-spanning external fixator versus an invented low cost wrist-spanning radio-metacarpal external fixator for comminuted displaced distal radius fractures
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SLCTR Registration Number
SLCTR/2017/009
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Non-randomized controlled trial on the stability and outcome of the conventional wrist-spanning external fixator versus an invented low cost wrist-spanning radio-metacarpal external fixator for comminuted displaced distal radius fractures
Public Title of Trial
Research study comparing the effectiveness of a new device used for a type of wrist fractures
Disease or Health Condition(s) Studied
Distal Radius Fractures
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1186-4791
Any other number(s) assigned to the trial and issuing authority
ERC/015/021 (ERC:SLMA)
What is the research question being addressed?
What is the stability and outcome of an invented low cost wrist-spanning radio-metacarpal external fixator compared to the conventional wrist-spanning external fixator in patients with comminuted displaced distal radius fractures?
Type of study
Interventional
Study design
Allocation
Non-randomized controlled trial
Masking
Masking not used
Control
Historical
Assignment
Other
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
Study setting: Designated Orthopaedic Unit (Dr. R. Sooriyarachchi, Consultant Orthopaedic Surgeon), National Hospital of Sri Lanka.
Experimental / Study group: Patients admitting with severely comminuted and displaced distal radius fractures where external fixation is indicated
Control group: Patients who were managed according to standard protocols in the Orthopaedic Unit, with the existing external fixators designed for distal radius fractures during the preceding 1 year of period, matched to the characteristics of the study group.
All participants will receive supportive care in accordance with standard unit protocols
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Presence of pain at wrist with movement while on external fixator (assessed using a 5 point scale) |
[ At week 1,4,6 and 12 post-operatively ] |
|
2.
Presence of pin-site infections – Grade 4,5,6 (Checketts–Otterburn classification |
[ At week 1,4,6 and 12 post-operatively ] |
|
3.
Presence of significant wrist joint stiffness with reduced range of movement by 50% or more (< 750) on clinical examination |
[ At week 1,4,6 and 12 post-operatively ] |
|
4.
Radial height being less than 2mm (radiological examination) |
[ At week 1,4,6 and 12 post-operatively ] |
|
5.
Radial length being less than 8mm (radiological examination) |
[ At week 1,4,6 and 12 post-operatively ] |
|
6.
Radial inclination being less than 100 (radiological examination) |
[ At week 1,4,6 and 12 post-operatively ] |
|
7.
Negative value for volar tilt (on radiological examination) |
[ At week 1,4,6 and 12 post-operatively ] |
|
8.
Intra-articular step more than 2mm (radiological examination) |
[ At week 1,4,6 and 12 post-operatively ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
168 (84 in the intervention arm and 84 matched historical controls)
Countries of recruitment
Sri Lanka
Anticipated start date
2018-02-01
Anticipated end date
2019-01-30
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2016-10-24
Approval number
ERC/015/021
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Sri Lanka Medical Association, |
| Institutional Address: | No 6, Wijerama Mawatha, Colombo 00700 Sri Lanka |
| Telephone: | +94-11-2693324 |
| Email: | erc.slma@gmail.com |
Contact person for Scientific Queries/Principal Investigator
G.A.L. Niroshana
Registrar in Orthopedic Surgery
Orthopedic Unit
National Hospital of Sri Lanka
Colombo 00800
Sri Lanka
Tel: 0112-691111
Mob: 0772-605841
lamindu@yahoo.com
Contact Person for Public Queries
Dr R Sooriyarachchi
Consultant Orthopaedic Surgeon
Orthopaedic Unit
National Hospital of Sri Lanka
Colombo 00800
Sri Lanka
Tel: 0112-691111
Mob: O777600600
ruksoo@gmail.com
Primary study sponsor/organization
Orthopedic Unit, National Hospital of Sri Lanka
Colombo 00800
Sri Lanka
Tel: 0112691111 (Ext – 2274)
Fax: 0112698443
www.nhsl.health.gov.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
