Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000026022
Ethics application status
Approved
Date submitted
1/11/2009
Date registered
11/01/2010
Date last updated
24/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomized Clinical Trial to compare straight arm skin traction and olecranon skeletal traction for displaced supracondylar fractures of the humerus in children
Scientific title
Randomised clinical trial to compare the effect of straight arm skin traction versus olecranon skeletal traction on cubitus varus deformity and range of movement in children with displaced supracondylar fracture of the humerus.
Secondary ID [1] 1258 0
Nil
Universal Trial Number (UTN)
Trial acronym
SCFSTVSOT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
supracondylar fracture treatment by overhead skeletal olecranon traction vs stright-arm skin traction 252091 0
Condition category
Condition code
Injuries and Accidents 252297 252297 0 0
Fractures
Surgery 252366 252366 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Skeletal traction protocol consists on (i) application of the olecranon skeletal traction with Steinmann pin and frame under generals anaesthesia, (ii) overhead traction with 1.5 to 2 kg weight, with the forearm in supination and supported on ventral long arm slab, with the elbow positioned at 90 degrees of flexion (iii) continuation of traction from 2 – 3 weeks depending on the child’s age. When the patient could actively lift the arm off the pillow, usually 14 to 18 days after the injury, traction was removed and the elbow was rested in a sling and the patient was discharged. Active mobilization of the elbow was encouraged. No supervised physiotherapy was advised.
Intervention code [1] 255728 0
Treatment: Surgery
Comparator / control treatment
Skin traction protocol consists on (i) application of the skeletal traction to the forearm with the patient under sedation, (ii) the extremity positioned with the elbow in extension and elevated, the arm was rested on a pillow.  (iii) usual weight 1-1.5 kg, (iv) the continuation of traction from 2-3 weeks depending on child’s age. When the patient could actively lift the arm off the pillow, usually 14 to 18 days after the injury, traction was removed and the elbow was rested in a sling and the patient was discharged. Active mobilization of the elbow was encouraged. No supervised physiotherapy was advised.
Control group
Active

Outcomes
Primary outcome [1] 253170 0
cubitus varus
The carrying angle (cubitus varus) is measured with a goniometer placed on the anterior aspect of the upper limb with the elbow in extension and the forearm in supination. The axis of the goniometer is placed over the center of the cubital fossa, its proximal arm aligned with the humeral shaft and its distal arm lying on a line from the center of the antecubital fossa to the center of the wrist.
Timepoint [1] 253170 0
3 months follow-up
however if the patient does not present to the clinic we try to call the patient and assess up to 6 moths after the procedure
Primary outcome [2] 253171 0
elbow range of movement
The flexion ROM and extension ROM were measured with a goniometer placed on the lateral aspect of the elbow with the axis of the goniometer centered over the lateral epicondyle of the humerus.
Timepoint [2] 253171 0
3 months follow-up
however if the patient does not present to the clinic we try to call the patient and assess up to 6 moths after the procedure
Secondary outcome [1] 262073 0
complications rate
Neurovascular deficit was assessed clinically. Radiographs were checked for the presence of myositis ossificans.
Timepoint [1] 262073 0
3 months follow-up
however if the patient does not present to the clinic we try to call the patient and assess up to 6 moths after the procedure

Eligibility
Key inclusion criteria
all consecutive patients admitted to the orthopaedic unit of Port Moresby General Hospital with diagnosed displaced (type II and III Gartland classification) supracondylar fracture of the humerus
Minimum age
No limit
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with type I undisplaced supracondylar fracture of the humerus
open fractures, intrarticular fractures, associated ipsilateral limb fractures, any visceral or head injury, or any previous treatment at a hospital elsewhere for the same injury
over 16 years of age

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
doctor enrolling the patient draw an opaque sealed envelope from a single box, after opening the envelope the patient is allocated to the tretment group and the allocation group is marked on the research paper
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple hand drawing by chance from a single box containing 60 opaque, sealed and identical envelopes containg allocation to the group (30 for each group)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
strict intention-to-treat analysis with mean/median imputation
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2009
Actual
12/04/2009
Date of last participant enrolment
Anticipated
Actual
8/12/2012
Date of last data collection
Anticipated
Actual
26/05/2013
Sample size
Target
133
Accrual to date
Final
133
Recruitment outside Australia
Country [1] 2302 0
Papua New Guinea
State/province [1] 2302 0
Central Province (Port Moresby) and Madang Province

Funding & Sponsors
Funding source category [1] 256202 0
Self funded/Unfunded
Name [1] 256202 0
Jerzy Kuzma
Country [1] 256202 0
Papua New Guinea
Primary sponsor type
Individual
Name
Jerzy Kuzma
Address
PO Box 1317, Boroko, NCD (no post code in PNG) Koneva Pl lot 8 sec 83
Country
Papua New Guinea
Secondary sponsor category [1] 251543 0
None
Name [1] 251543 0
Address [1] 251543 0
Country [1] 251543 0
Other collaborator category [1] 919 0
University
Name [1] 919 0
University of Papua New Guinea (UPNG)
Address [1] 919 0
UPNG School of Medicine and Health Sciences PO Box 5623 Boroko, NCD, Port Moresby (no postcode in PNG)
Country [1] 919 0
Papua New Guinea
Other collaborator category [2] 280220 0
University
Name [2] 280220 0
Divine Word University
Address [2] 280220 0
DWU PO Box 483
Madang
Country [2] 280220 0
Papua New Guinea

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244063 0
Ethics Committee of UPNG
Ethics committee address [1] 244063 0
School of Medicine & Health Sciences
PO Box 5623, Boroko, NCD
(no postcode in PNG)
Ethics committee country [1] 244063 0
Papua New Guinea
Date submitted for ethics approval [1] 244063 0
10/03/2009
Approval date [1] 244063 0
30/03/2009
Ethics approval number [1] 244063 0

Summary
Brief summary
The primary aim of this study is to compare the outcome of 2 different methods of managing displaced supracondylar fractures of humerus applicable in the setting of a tropical hospital characterized by lack of access to the image intensifier as well as limited access to specialized orthopaedic services. Although current literature supports percutaneous pinning of displaced supracondylar fractures of the humerus as preferable method rending the best results, one should notice that this method is not easily applicable in the developing counties. This study may provide good evidence for the development of clinical practice guidelines for the management of supracondylar fracture of the humerus in developing countries characterized by both lack of image intensifier and specialized orthopaedic services.
Trial website
Trial related presentations / publications
Kuzma J. (2014). A Comparison of Skin vs. Skeletal Traction in the Management of Childhood Humeral Supracondylar Fractures: Randomized Clinical Trial. The Internet Journal of Orthopedic Surgery, 22 (1).
Public notes

Contacts
Principal investigator
Name 30442 0
Prof Jerzy Kuzma
Address 30442 0
Divine Word University
PO Box 483, Madang 511
Papua New Guinea
Country 30442 0
Papua New Guinea
Phone 30442 0
+675 70057603
Fax 30442 0
Email 30442 0
[email protected]
Contact person for public queries
Name 13689 0
Prof Jerzy Kuzma
Address 13689 0
Divine Word University
PO Box 483, Madang 511
Papua New Guinea
Country 13689 0
Papua New Guinea
Phone 13689 0
+675 70057603
Fax 13689 0
675 3233855
Email 13689 0
[email protected]
Contact person for scientific queries
Name 4617 0
Prof Jerzy Kuzma
Address 4617 0
Divine Word University
PO Box 483, Madang 511
Papua New Guinea
Country 4617 0
Papua New Guinea
Phone 4617 0
+675 71776130
Fax 4617 0
675 3233855
Email 4617 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.