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)
Scientific title
Long term outcome of peri-acetabular osteotomy and the efficacy of Arthroscopic surgery prior to the index procedure
Secondary ID [1] 281594 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip arthroscopy 287875 0
Peri-Acetabular Osteotomy surgery 287892 0
Condition category
Condition code
Surgery 288241 288241 0 0
Surgical techniques
Musculoskeletal 288270 288270 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 286121 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288431 0
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.
Timepoint [1] 288431 0
Retrospective data- over 2001 to 2008

8 months will be the time for data collection and data analysis
Primary outcome [2] 288445 0
We will then evaluate patient outcomes following these hip arthroscopy and peri-acetabular osteotomy (PAO)
Timepoint [2] 288445 0
Retrospective data- over 2001 to 2008

8 months will be the time for data collection and data analysis
Secondary outcome [1] 300145 0
Nil
Timepoint [1] 300145 0
Nil

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
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286401 0
Self funded/Unfunded
Name [1] 286401 0
Dr David Young
Country [1] 286401 0
Australia
Primary sponsor type
Individual
Name
Dr David Young
Address
33 The Avenue
Windsor 3181 VIC
Country
Australia
Secondary sponsor category [1] 285183 0
Individual
Name [1] 285183 0
Dr Brett Moreira
Address [1] 285183 0
33 The Avenue
Windsor 3181 VIC
Country [1] 285183 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288465 0
The Avenue Hospital Ethics Committee
Ethics committee address [1] 288465 0
The Avenue Hospital
40 The Avenue
Windsor VIC 3181
Ethics committee country [1] 288465 0
Australia
Date submitted for ethics approval [1] 288465 0
Approval date [1] 288465 0
21/05/2012
Ethics approval number [1] 288465 0
Trial 134 -Long term outcome of peri-acetabular osteotomy and the efficacy of Arthroscopic surgery prior to the index procedure

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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34988 0
Address 34988 0
Country 34988 0
Phone 34988 0
Fax 34988 0
Email 34988 0
Contact person for public queries
Name 18235 0
Dr Brett Moreira
Address 18235 0
33 The Avenue
Windsor 3181 VIC
Country 18235 0
Australia
Phone 18235 0
+61 402344463
Fax 18235 0
Email 18235 0
[email protected]
Contact person for scientific queries
Name 9163 0
Dr Brett Moreira
Address 9163 0
33 The Avenue
Windsor 3181 VIC
Country 9163 0
Australia
Phone 9163 0
+61 402344463
Fax 9163 0
Email 9163 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.