Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000618257
Ethics application status
Approved
Date submitted
22/07/2009
Date registered
27/07/2009
Date last updated
6/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
In patients with bony impingement of the hip, what is the impact of computer-assisted surgery in assisting arthroscopic procedures, assessed by surgical, quality of life and functional outcomes up to 6 months post-operatively
Scientific title
In patients with bony impingement of the hip, what is the impact of computer-assisted surgery in assisting arthroscopic procedures, assessed by surgical, quality of life and functional outcomes up to 6 months post-operatively.
Secondary ID [1] 262147 0
None.
Universal Trial Number (UTN)
U1111-1121-3201
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Femoroacetabular impingement of the proximal femur 237319 0
Condition category
Condition code
Musculoskeletal 239642 239642 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Resection of bone from the head-neck junction will be performed using a burr, introduced into the hip joint via an arthroscopic procedure under the guidance of a combination of visual (camera), radiological (X-ray image intensifier) and computer-guided imaging modalities. The approximate duration of the procedure is 60-90 minutes.
Intervention code [1] 236991 0
Treatment: Surgery
Comparator / control treatment
Not a controlled study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238427 0
Amount of bone resected for removal of the impingement lesion as visualised by Computed Tomography (CT) scan.
Timepoint [1] 238427 0
Pre-operative; Post-operative up to 8 weeks.
Secondary outcome [1] 244913 0
Hip function assessed before and after surgery using Hip disability and Osteoarthritis Outcome Score (HOOS) and Non-Arthritic Hip Score.
Timepoint [1] 244913 0
Pre-operative, 8 weeks post-operative, 12 weeks post-operative, 6 months post-operative.
Secondary outcome [2] 244914 0
Pain assessed before and after surgery using Visual Analog Scale (VAS) pain score.
Timepoint [2] 244914 0
Pre-operative, 8 weeks post-operative, 12 weeks post-operative, 6 months post-operative.
Secondary outcome [3] 244956 0
Quality of life assessed before and after surgery using SF-12 version 2 and Patient Satisfaction Questionnaire.
Timepoint [3] 244956 0
Pre-operative, 8 weeks post-operative, 12 weeks post-operative, 6 months post-operative.
Secondary outcome [4] 244957 0
Total radiation exposure to subjects measured by X-ray settings and number of exposures.
Timepoint [4] 244957 0
Including pre-operative CT, intra-operative use of X-ray image intensifier and post-operative CT.

Eligibility
Key inclusion criteria
1. 18- 50 years of age at time of surgery
2. A greater than 6 month history of femoroacetabular impingement (FAI) prior to surgery (as diagnosed via surgeon assessment of hip) where impingement lesion is present on the femoral component.
3. A greater than 6 month history of conservative treatment prior to surgery
4. Patients indicated for treatment of FAI by arthroscopic femoroplasty.
5. Patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow-up
6. Patients who are capable of, and have given, informed consent to their participation in the study
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnant and breast feeding women
2. Patients with femoroacetabular impingement where the impingement lesion is present on the acetabular or labral components.
3. Patients with previous surgery of the affected hip
4. Patients with advanced hip osteoarthritis
Patients requiring bilateral hip surgery
5. Patients with other musculoskeletal disorders that, per investigator’s discretion, are affecting pain levels and physical activity.
6. Patients with any other disorders that, per investigator’s discretion, are significantly affecting pain levels, physical activity, or quality of life.

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)
Not applicable.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237377 0
Commercial sector/Industry
Name [1] 237377 0
Stryker Australia
Country [1] 237377 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Stryker Australia
Address
8 Herbert Street
ST LEONARDS
N.S.W. 2065
Country
Australia
Secondary sponsor category [1] 236876 0
None
Name [1] 236876 0
Address [1] 236876 0
Country [1] 236876 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239509 0
The Avenue Hospital Human Research Ethics Committee
Ethics committee address [1] 239509 0
40 The Avenue
WINDSOR VIC 3181
Ethics committee country [1] 239509 0
Australia
Date submitted for ethics approval [1] 239509 0
25/07/2009
Approval date [1] 239509 0
16/11/2009
Ethics approval number [1] 239509 0
Trial No 107

Summary
Brief summary
Thus study aims to investigate new methods of treating a specific cause of hip pain, where the top of the thigh bone hits against the pelvic bone. Existing keyhole surgery techniques will be combined with a new computer-assisted method to determine if the surgery can be improved. Patients will be assessed before and after their operation to measure activity, pain and quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29942 0
Address 29942 0
Country 29942 0
Phone 29942 0
Fax 29942 0
Email 29942 0
Contact person for public queries
Name 13189 0
Dr Timothy Barker
Address 13189 0
Director of Clinical Research
Stryker Australia
8 Herbert Street
ST LEONARDS N.S.W. 2065
Country 13189 0
Australia
Phone 13189 0
+61 2 9467 1000
Fax 13189 0
Email 13189 0
[email protected]
Contact person for scientific queries
Name 4117 0
Dr Timothy Barker
Address 4117 0
Director of Clinical Research
Stryker Australia
8 Herbert Street
ST LEONARDS N.S.W. 2065
Country 4117 0
Australia
Phone 4117 0
+61 2 9467 1000
Fax 4117 0
Email 4117 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.