Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001203842
Ethics application status
Approved
Date submitted
11/11/2012
Date registered
15/11/2012
Date last updated
15/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The role of Arthroscopy in investigating and managing the painful resurfacing hip arthroplasty
Scientific title
The role of Arthroscopy in investigating and managing the painful resurfacing hip arthroplasty
Secondary ID [1] 281275 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
This retrospective study aims to evaluate the role of hip arthroscopy in patients who have undergone hip resurfacing surgery and who continue to have symptoms in the same hip. 287471 0
Condition category
Condition code
Musculoskeletal 287803 287803 0 0
Other muscular and skeletal disorders
Surgery 287804 287804 0 0
Other surgery

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 the role of hip arthroscopy in patients who have undergone hip resurfacing surgery and who continue to have symptoms in the same hip.


Symptoms may include pain, stiffness, clicking, giving way episodes or weakness. Pathologies causing these symptoms, which reside within the hip joint can be more accurately assessed and treated by the insertion of an arthoscope within the hip joint capsule.

The study involves reviewing patient files and operating notes from 2001-2008, and subsequently conducting a phone call or a follow up visit, if possible, to evaluate current patient status. There will not be follow up appointments made specifically for fulfilling the purposes of the study. However, if the patient is attending a pre-booked follow up visit, then evaluation of patient functional status will be carried out concurrently.

The source of this data will be from patients treated and seen through the Melbourne Orthopaedic Group.
Intervention code [1] 286024 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288338 0
To assess and measure the benefit of arthroscopy when managing a symptomatic resurfaced hip arthroplasty.


Results will be analysed by the researchers and then published in formal medical scientific journals. There is currently no standard scoring or analysis tools in this unique area of surgery, however 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] 288338 0
6 months will be the time for data collection and data analysis
Secondary outcome [1] 299908 0
Nil
Timepoint [1] 299908 0
Nil

Eligibility
Key inclusion criteria
a. Male or female patients aged between 30-65
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
30 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. Patients with major ligamentous laxity
b. Patients with extreme ROM needs (such as ballet dancers)
c. Patients suffering from connective tissue disease
d. Adjuvant required surgical procedure to common cam FAI surgery (such as IP release)

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

Recruitment
Recruitment status
Recruiting
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
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286305 0
Self funded/Unfunded
Name [1] 286305 0
Dr David Young
Country [1] 286305 0
Australia
Primary sponsor type
Individual
Name
Dr David Young
Address
33 The Avenue
Windsor 3181 VIC
Country
Australia
Secondary sponsor category [1] 285093 0
Individual
Name [1] 285093 0
Dr Brett Moreira
Address [1] 285093 0
33 The Avenue
Windsor 3181 VIC
Country [1] 285093 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288376 0
The Avenue Hospital Ethics Committee
Ethics committee address [1] 288376 0
Ethics committee country [1] 288376 0
Australia
Date submitted for ethics approval [1] 288376 0
Approval date [1] 288376 0
21/05/2012
Ethics approval number [1] 288376 0
Trial 138

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

Contacts
Principal investigator
Name 34741 0
Address 34741 0
Country 34741 0
Phone 34741 0
Fax 34741 0
Email 34741 0
Contact person for public queries
Name 17988 0
Dr Brett Moreira
Address 17988 0
33 The Avenue
Windsor 3181 VIC
Country 17988 0
Australia
Phone 17988 0
+61 402344463
Fax 17988 0
Email 17988 0
[email protected]
Contact person for scientific queries
Name 8916 0
Dr Brett Moreira
Address 8916 0
33 The Avenue
Windsor 3181 VIC
Country 8916 0
Australia
Phone 8916 0
+61 402344463
Fax 8916 0
Email 8916 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.