Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000730000
Ethics application status
Not yet submitted
Date submitted
1/09/2010
Date registered
2/09/2010
Date last updated
2/09/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Minimally invasive versus standard open reduction of proximal humerus fractures
Scientific title
A prospective randomised controlled trial comparing clinical and radiographic outcomes of the deltopectoral and limited deltoid splitting approaches for fixation of displaced proximal humeral fractures in a skeletally mature population
Secondary ID [1] 252606 0
No secondary ID
Universal Trial Number (UTN)
No UTN available
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Proximal humerus fractures 258104 0
Condition category
Condition code
Injuries and Accidents 258282 258282 0 0
Fractures
Surgery 258283 258283 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The minimally invasive technique involves reduction of the fracture using closed methods and temporary fixation with k-wires to hold the fracture together. A small incision and approach is then performed directly through the deltoid muscle and a locking plate is placed down onto the bone via this small incision. It is then locked into place with a series of small stab incisions which allow placement of screws through the plate to hold it on the bone. The potential advantage is less surgical dissection with a faster recovery time and less disruption of the fracture fragments which may lead to better rates of fracture union. This duration of this procedure is approximately 90-120 minutes.
Intervention code [1] 257126 0
Treatment: Surgery
Comparator / control treatment
Standard open reduction internal fixation is via the deltopectoral approach which uses a large incision and is the most common method of fixing proximal humeral fractures. This technique allows the surgeon to identify all the parts of the fracture and put them back together under direct vision. It however means more surgical dissection and possible disruption of blood supply to the fracture fragments which may lead to higher nonunion rates. It may also take longer to recover from the larger surgical approach. The duration of this procedure is approximately 90-120 minutes.
Control group
Active

Outcomes
Primary outcome [1] 259124 0
The constant score combines physical examination tests with subjective evaluation by the patients. The subjective assessment consists of 35 points and the remaining 65 points are assigned for the physical examination assessment. The subjective assessment includes a single item for pain and 4 items for activities of daily living. The objective assessment includes range of motion and power. The total possible score is 100 points. The constant score has become the most widely used shoulder evaluation instrument in Europe.
Timepoint [1] 259124 0
6 weeks, 3,6 and 12 months following surgery.
Primary outcome [2] 259125 0
The Disabilities of the Arm, Shoulder and Hand ( DASH ) score is a 30-item, self report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. It is a valid, reliable and responsive tool that is commonly used for clinical and research purposes.
Timepoint [2] 259125 0
6 weeks, 3,6 and 12 months following surgery
Secondary outcome [1] 265440 0
radiographic outcomes to be assessed are the fracture reduction quality and the rate of union radiographically. We will also be looking at complications which can be seen radiographically eg malunion, nonunion, malposition of the hardware, osteonecrosis
Timepoint [1] 265440 0
6 weeks, 3,6 and 12 months following surgery
Secondary outcome [2] 265441 0
Possible complications such as the following:
- failure of fixation - seen on xrays
- malunion - seen on xrays
- nonunion - seen on xrays and clinical examination
- osteonecrosis - seen on xrays
- malposition of the hardware - seen on xrays
- wound infection - clinical examination
- neurovascular damage - clinical examination
Timepoint [2] 265441 0
6 weeks, 3,6 and 12 months following surgery
Secondary outcome [3] 265442 0
union rate - seen on xrays as evidence of fracture healing with bridging callus. Plus clinical examination of fracture site for pain, movement of the fracture or loss of fixation
Timepoint [3] 265442 0
6 weeks, 3,6 and12 months following surgery

Eligibility
Key inclusion criteria
skeletal maturity
able to sign consent and comply with treatment
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
compound injuries
previous surgery to upper limb
previous known upper limb dysfunction
neuromuscular disorder affecting upper limb
significant neurological deficit at time of injury
pathologic fracture
major medical comorbidities precluding surgical intervention

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)
This is a 2 surgeon study with one surgeon performing standard open reduction internal fixation with the other surgeon performing a limited deltoid splitting approach.
When a patient presents to our institution with a proximal humerus fracture and meets the inclusion criteria for the trial, the available imaging will be reviewed by the participating surgeons. If both agree the patient should be treated with plate fixation then the patient will be approached to enter the trial. If they agree, they will then be randomized by a computer generated random number list to one of the above surgeons. Concealment of allocation is established by using sealed numbered envelopes. The envelope will be opened and the patient will be allocated that operation group. The surgeon will then be informed and the surgery will take place on the next available list.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random number list
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 2845 0
New Zealand
State/province [1] 2845 0

Funding & Sponsors
Funding source category [1] 257567 0
Hospital
Name [1] 257567 0
Auckland Public Hospital
Country [1] 257567 0
New Zealand
Primary sponsor type
Government body
Name
Auckland District Health Board
Address
214 Green Lane West
Epsom
Auckland 1042
Country
New Zealand
Secondary sponsor category [1] 256792 0
None
Name [1] 256792 0
Address [1] 256792 0
Country [1] 256792 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259592 0
Northern Region Ethical Committee
Ethics committee address [1] 259592 0
Ethics committee country [1] 259592 0
New Zealand
Date submitted for ethics approval [1] 259592 0
26/08/2010
Approval date [1] 259592 0
Ethics approval number [1] 259592 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31591 0
Address 31591 0
Country 31591 0
Phone 31591 0
Fax 31591 0
Email 31591 0
Contact person for public queries
Name 14838 0
Jeremy Stanley
Address 14838 0
14 Grand Drive
Remuera
Auckland 1050
Country 14838 0
New Zealand
Phone 14838 0
(64) 021527826
Fax 14838 0
Email 14838 0
[email protected]
Contact person for scientific queries
Name 5766 0
Jeremy Stanley
Address 5766 0
14 Grand Drive
Remuera
Auckland 1050
Country 5766 0
New Zealand
Phone 5766 0
(64) 021527826
Fax 5766 0
Email 5766 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
SourceTitleYear of PublicationDOI
EmbaseInterventions for treating proximal humeral fractures in adults.2015https://dx.doi.org/10.1002/14651858.CD000434.pub4
N.B. These documents automatically identified may not have been verified by the study sponsor.