Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001007628
Ethics application status
Approved
Date submitted
10/09/2014
Date registered
18/09/2014
Date last updated
24/07/2020
Date data sharing statement initially provided
24/07/2020
Date results information initially provided
24/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Hip arthroscopy effect on physical activity and pain
Scientific title
In patients with a symptomatic hip labral tear, does hip arthroscopy improve physical activity level, pain and quality of life?
Secondary ID [1] 285317 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip labral tear 293032 0
Condition category
Condition code
Musculoskeletal 293302 293302 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arthroscopic hip surgery entails inserting a small camera into the hip joint to enable the surgeon to view, diagnose and treat hip pathology of the labrum, articular cartilage, or other soft tissues surrounding the joint. The surgeon inserts other instruments through separate incisions to smooth off or repair torn cartilage, trim bone spurs and/or remove inflamed synovial tissue. The procedure takes 30-45 minutes.
Intervention code [1] 290229 0
Treatment: Surgery
Comparator / control treatment
Preoperative compared to 3 month and 1 year postoperative status
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293140 0
Average daily steps taken assessed using a wearable accelerometer
Timepoint [1] 293140 0
Preoperative, 3 months, 1 year
Primary outcome [2] 293141 0
Pain report using a 100mm visual analogue scale anchored with 2 descriptors "no pain at all" and "extreme pain"
Timepoint [2] 293141 0
Preoperative, 3 month, 1 year
Secondary outcome [1] 310437 0
Quality of Life iHOT-12 survey
Timepoint [1] 310437 0
Preoperative, 3 months, 1 year
Secondary outcome [2] 310438 0
Satisfaction level assessed using a 5 point likert scale (very satisfied, satisfied, neutral, dissatisfied, very dissatisfied)
Timepoint [2] 310438 0
3 months and 1 year postoperative

Eligibility
Key inclusion criteria
- Patients with acetabular labrum pathology who are candidates for arthroscopic hip surgery as determined by the surgeon and patient.
- Patients who understand the conditions of the study and are willing to participate with follow up
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous major ipsilateral hip surgery.
- Evidence of boney hip pathology other than femoroacetabular impingement (e.g. fracture, avascular necrosis, osteomyelitis, osseous neoplasm).
- Women who are pregnant or seeking to become pregnant during the study period.
- Patients who are a prisoner, currently being treated for a psychiatric disorder, senile dementia, Alzheimers disease, or known alcohol abuse
- Patients with comorbidities rendering them house-bound with severe mobility impairment (e.g. Limb amputation, Multiple Sclerosis, Muscular DystrophyParkinson’s Disease, cerebrovascular accident, lower limb fracture, severe back pain).
- Patients with known metal allergy.

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)
Prospective, single-centre, non-randomised, clinical study. The study will enrol 50 participants over a 12 month period
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/11/2014
Actual
9/02/2015
Date of last participant enrolment
Anticipated
Actual
29/06/2016
Date of last data collection
Anticipated
29/06/2017
Actual
29/06/2017
Sample size
Target
50
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 2975 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 8686 0
6009 - Broadway Nedlands

Funding & Sponsors
Funding source category [1] 289940 0
Other
Name [1] 289940 0
The Joint Studio Research Fund
Country [1] 289940 0
Australia
Primary sponsor type
Other
Name
The Joint Studio
Address
1/ 86 Monash Ave
Nedlands WA 6019
Country
Australia
Secondary sponsor category [1] 288629 0
None
Name [1] 288629 0
Address [1] 288629 0
Country [1] 288629 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291654 0
Hollywood Private Hospital Ethics
Ethics committee address [1] 291654 0
Monash Ave, Nedlands, WA 6009
Ethics committee country [1] 291654 0
Australia
Date submitted for ethics approval [1] 291654 0
08/09/2014
Approval date [1] 291654 0
18/12/2014
Ethics approval number [1] 291654 0
HPH390

Summary
Brief summary
Taking 10,000 steps a day is promoted by The Centres of Disease Control and Prevention, and The American College of Sports Medicine to equate to a healthy level of physical activity (Pate et al, 1995). Through the use of wearable activity monitors, this study will objectively quantify the limitation in physical activity that hip labral tear patients subjectively report. The study aims to determine whether hip arthroscopic surgery improves physical activity, pain, and quality of life. Satisfaction with surgery will also be assessed and provide further insight into the efficacy of arthroscopic hip surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51358 0
Dr Dan Fick
Address 51358 0
The Joint Studio
Suite 1, Hollywood Medical Centre
86 Monash Ave
Nedlands WA 6009
Country 51358 0
Australia
Phone 51358 0
+61 8 93863933
Fax 51358 0
Email 51358 0
info@thejointstudio.com.au
Contact person for public queries
Name 51359 0
Ms Samantha Haebich
Address 51359 0
The Joint Studio
Suite 1, Hollywood Medical Centre
86 Monash Ave
Nedlands WA 6009
Country 51359 0
Australia
Phone 51359 0
+61 8 93863933
Fax 51359 0
Email 51359 0
research@thejointstudio.com.au
Contact person for scientific queries
Name 51360 0
Ms Samantha Haebich
Address 51360 0
The Joint Studio
Suite 1, Hollywood Medical Centre
86 Monash Ave
Nedlands WA 6009
Country 51360 0
Australia
Phone 51360 0
+61 8 93863933
Fax 51360 0
Email 51360 0
research@thejointstudio.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.