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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12612001262897
Ethics application status
Approved
Date submitted
27/11/2012
Date registered
3/12/2012
Date last updated
3/12/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
Is arthroscopic hip surgery beneficial for patients undergoing Peri-Acetabular Osteotomy (PAO)
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Scientific title
Long term outcome of peri-acetabular osteotomy and the efficacy of Arthroscopic surgery prior to the index procedure
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Secondary ID [1]
281594
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nil
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Universal Trial Number (UTN)
nil
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Trial acronym
nil
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hip arthroscopy
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Peri-Acetabular Osteotomy surgery
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Condition category
Condition code
Surgery
288241
288241
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0
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Surgical techniques
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Musculoskeletal
288270
288270
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
This retrospective study aims to evaluate long term outcome of patients who underwent hip arthroscopy prior to peri-acetabular osteotomy (PAO) surgery.
The study involves reviewing patient files and operating notes with a subsequent phone call or a follow up visit (as per normal scheduled patient follow-up post surgery), if possible, to evaluate current patient status.
Participants for this study are located/recruited from clinic patient files from the date range 2001 to 2008.
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Intervention code [1]
286121
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Not applicable
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Comparator / control treatment
Nil
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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We aim to evaluate the importance of arthroscopy prior to the osteotomy procedure. This is to supply the surgeon with additional valuable pre-operative data which will establish a better treatment strategy.
the validated scoring clinical tools of the WOMAC hip score, Mahorn Hip Outcome Tool (MHOT) and the Non-arthritic hip score will provide functional quantitative data. Total assessment of clinical signs and symptoms will also be analysed. This will allow for a greater proportion of qualitative analysis, combined with the quantitative data collected via the validated questionnaires.
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Assessment method [1]
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Timepoint [1]
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Retrospective data- over 2001 to 2008
8 months will be the time for data collection and data analysis
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Primary outcome [2]
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We will then evaluate patient outcomes following these hip arthroscopy and peri-acetabular osteotomy (PAO)
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Assessment method [2]
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Timepoint [2]
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Retrospective data- over 2001 to 2008
8 months will be the time for data collection and data analysis
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Secondary outcome [1]
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Nil
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Assessment method [1]
300145
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Timepoint [1]
300145
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Nil
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Eligibility
Key inclusion criteria
a. Male or female patients aged between 20-65
b. Healthy patients undergoing hip Arthroscopy due to painful hip arthroplasty
c. No other influential disabilities in lower limbs
d. No chronic use of NSAID, analgesics, steroids or chemotherapy drugs
e. Base line activity level - Tegner 3 and above
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Minimum age
20
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
a. Patients with concomitant disease, that may affect joints
b. Patients with major ligamentous laxity
c. Patients which have undergone only minor vertical capsulotomy (pincer only
lesions)
d. Patients with extreme ROM needs (such as ballet dancers)
e. Patients suffering from connective tissue disease
f. Patients suffering from bilateral symptomatic FAI operated for their first hip
g. Patients with relative or proved displastic hip determined by CE angle and/or
extreme version abnormalities as measured on apical CT/MR cuts and pelvic XR
h. Adjuvant required surgical procedure to common cam FAI surgery (such as IP
release)
i. Patients whom their cartilage hip status was define as advanced OA, during surgery,
or patients which, following surgery, would be instructed to avoid full weight
bearing on the operated hip for more than 4 weeks
j. Concomitant use of PRP or TA during the surgical procedure
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Study design
Purpose
Screening
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Duration
Longitudinal
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Selection
Defined population
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/06/2012
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
25
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Dr David Young
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Address [1]
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33 The Avenue
Windsor 3181 VIC
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Country [1]
286401
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Australia
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Primary sponsor type
Individual
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Name
Dr David Young
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Address
33 The Avenue
Windsor 3181 VIC
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Country
Australia
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Secondary sponsor category [1]
285183
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Individual
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Name [1]
285183
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Dr Brett Moreira
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Address [1]
285183
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33 The Avenue
Windsor 3181 VIC
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Country [1]
285183
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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The Avenue Hospital Ethics Committee
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Ethics committee address [1]
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The Avenue Hospital
40 The Avenue
Windsor VIC 3181
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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Approval date [1]
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21/05/2012
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Ethics approval number [1]
288465
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Trial 134 -Long term outcome of peri-acetabular osteotomy and the efficacy of Arthroscopic surgery prior to the index procedure
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Summary
Brief summary
We aim to evaluate the importance of arthroscopy prior to the osteotomy procedure. This is to supply the surgeon with additional valuable pre-operative data which will establish a better treatment strategy. We will then evaluate patient outcomes following these two procedures.
This kind of osteotomy surgery aims to address an uncommon entity - mild hip dysplasia. Evaluation of this unique operation and its outcomes in this type of patient population will be invaluable in further improving patient care.
Key research questions:
1. Does PAO carry good long-term outcomes.
2. Is hip arthroscopy considered as a adjunctive procedure prior to PAO
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
34988
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Email
34988
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Contact person for public queries
Name
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Dr Brett Moreira
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Address
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33 The Avenue
Windsor 3181 VIC
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Country
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Australia
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Phone
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+61 402344463
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Fax
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Email
18235
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[email protected]
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Contact person for scientific queries
Name
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Dr Brett Moreira
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Address
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33 The Avenue
Windsor 3181 VIC
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Country
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Australia
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Phone
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+61 402344463
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Fax
9163
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Email
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[email protected]
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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.
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