Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000873820
Ethics application status
Approved
Date submitted
15/08/2012
Date registered
17/08/2012
Date last updated
19/09/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Non-guided hip injections are a safe and accurate method of treatment for patients undergoing hip arthroscopy due to Femeroacetabular Impingement (FAI)
Scientific title
To evaluate the efficacy of the anterior approach for blind intra-articular hip injections in patients undergoing hip arthroscopy due to Femoroacetabular Impingement (FAI)
Secondary ID [1] 281029 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
(Femoroacetabular Impingement) 287165 0
Condition category
Condition code
Musculoskeletal 287488 287488 0 0
Other muscular and skeletal disorders
Surgery 287489 287489 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment group will have a 19G spinal needle inserted into the anterior hip joint and followed by an air arthrogram (10ml of air inserted through needle). This air will enable the braking of the suction seal of the joint to enable traction, without which the surgery cannot commence. The position of the needle would then be verified by fluoroscopy. This process will take approximately 3-4 minutes and will be immediately followed by the commencement of the patient's scheduled hip arthroscopy surgery.
Intervention code [1] 285489 0
Treatment: Other
Comparator / control treatment
Nil control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287748 0
To validate the anterior hip injection technique without imaging guidance by showing it to be safe and yield high accuracy. Clinical assessment for all patients shall be made on enrollment, and at
7 days and 12 weeks post surgery. The clinical assessment will be according to the investigators physical exam, assessing (and measuring) patient's range of motion, mechanical symptoms,
pain and full neuro-vascular status. Possible side effects attributed to needle placement (sensation disturbance) will be monitored closely.
Timepoint [1] 287748 0
7 days, 12 weeks
Secondary outcome [1] 298777 0
Nil
Timepoint [1] 298777 0
Nil

Eligibility
Key inclusion criteria
Male or female patients aged between 18-50
healthy patients undergoing hip arthroscopy due to FAI
No previous total hip replacement surgery
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
a) Patients with relative or proven dysplastic hip joints determined by CE angle and/or extreme version abnormalities as measured on apical CT/MR cuts and pelvic XR.

b) patients with an artificial joint (Total hip replacement)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients who have elected to undergo a hip arthroscopy procedure due to labral or cartilage pathologies resulting from Femoroacetabular impingement. Patients meeting the primary inclusion criteria and whom agree to enroll in the study would constitute the study population.

Full verbal and written information regarding the trial and treatment. Screening forms completed along with demographic data and clinical examination and baseline outcome measures documented.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285817 0
Self funded/Unfunded
Name [1] 285817 0
Dr David Young
Country [1] 285817 0
Australia
Primary sponsor type
Individual
Name
Dr David Young
Address
33 The Avenue
Windsor 3181 VIC
Country
Australia
Secondary sponsor category [1] 284642 0
Individual
Name [1] 284642 0
Dr Brett Moreira
Address [1] 284642 0
33 The Avenue
WIndsor 3181 VIC
Country [1] 284642 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287829 0
The Avenue Hospital Ethics Committee
Ethics committee address [1] 287829 0
The Avenue Hospital
40 The Avenue
Windsor VIC 3181
Ethics committee country [1] 287829 0
Australia
Date submitted for ethics approval [1] 287829 0
24/02/2012
Approval date [1] 287829 0
05/04/2012
Ethics approval number [1] 287829 0
Trial 131

Summary
Brief summary
Lately, a new method for intraarticular hip injection has been increasingly considered, and is believed to be very accurate, eliminating the need for imaging assistance (which enables the surgeon to apply the treatment in an outpatient environment).

This blind method of injection will be assessed by:
1. Injecting small amount of air into the hip prior to hip arthroscopy surgery in the operating theatre, in the same technique as it is performed on a regular basis, but via a different approach (anterior versus lateral) and initially with no image assistance. The location of the needle will then be assessed using fluoroscopy.

2. Injecting small amount of Methylene Blue into the hip prior to total hip replacement surgery, verifying its location and injection accuracy later during the same operation.

Our hypothesis is that anterior hip injection technique, without imaging guidance, would yield high accuracy rates. Hip injections able to be performed without imaging will also lead to less expense for the patient and community with a reduction in burden on imaging services.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34578 0
Address 34578 0
Country 34578 0
Phone 34578 0
Fax 34578 0
Email 34578 0
Contact person for public queries
Name 17825 0
Dr Brett Moreira
Address 17825 0
33 The Avenue
Windsor 3181 VIC
Country 17825 0
Australia
Phone 17825 0
+61 402344463
Fax 17825 0
Email 17825 0
[email protected]
Contact person for scientific queries
Name 8753 0
Dr Brett Moreira
Address 8753 0
33 The Avenue
Windsor 3181 VIC
Country 8753 0
Australia
Phone 8753 0
+61 402344463
Fax 8753 0
Email 8753 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.