Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000051943
Ethics application status
Approved
Date submitted
9/12/2019
Date registered
22/01/2020
Date last updated
22/01/2020
Date data sharing statement initially provided
22/01/2020
Date results information initially provided
22/01/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Direct Anterior Approach to Hip Replacement and Associated Complications: A Retrospective Case Series
Scientific title
Direct Anterior Approach to Hip Replacement and Associated Complications: A Retrospective Case Series
Secondary ID [1] 300042 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hip replacement 315545 0
Surgical approach to hip replacement 315546 0
Condition category
Condition code
Surgery 313830 313830 0 0
Surgical techniques
Musculoskeletal 313880 313880 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In patients undergoing anterior approach to hip replacement, complications and Patient reported outcome scores were measured and analysed.
We received approval to assess medical records and contact patients to send questionnaires to collected this data. The questionnaires were completed at 2 and 5 years post surgery and took 10 minutes to complete . Our mean follow up was 3.7 years.
Intervention code [1] 316312 0
Not applicable
Comparator / control treatment
No control group, compared to evidence in literature
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322224 0
Complications like dislocations, infections, revision and lateral cutaneous nerve palsy rates were measured in our cohort. This was assessed via review of medical records and contacting patients over telephone interview.
Timepoint [1] 322224 0
Complications 2 years and 5 years post index surgery.
Secondary outcome [1] 377796 0
Oxford hip score. This is assessed via a patient questionnaire
Timepoint [1] 377796 0
2 and 5 years post surgery
Secondary outcome [2] 378246 0
Pain score. Visual analogue scale( VAS) for pain was used. Range 0-10
This was assessed via patient questionnaire
Timepoint [2] 378246 0
2 and 5 years post surgery
Secondary outcome [3] 378247 0
SF 12 score
This was assessed using a patient questionnaire
Timepoint [3] 378247 0
2 and 5 years post surgery
Secondary outcome [4] 378248 0
patient satisfaction with hip replacement. This was measured using 5-Point Likert Scale
Timepoint [4] 378248 0
2 and 5 years post surgery

Eligibility
Key inclusion criteria
Anterior approach to Primary total hip replacement
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
nil

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Both
Statistical methods / analysis
Studies all patients who underwent surgery over a 3 year time period and studied outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/02/2019
Date of last participant enrolment
Anticipated
Actual
30/09/2019
Date of last data collection
Anticipated
Actual
30/09/2019
Sample size
Target
300
Accrual to date
Final
281
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 304495 0
Other Collaborative groups
Name [1] 304495 0
The Joint Studio
Country [1] 304495 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The Joint Studio
Address
Suite 1/85 Monash Ave, Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 304762 0
None
Name [1] 304762 0
Address [1] 304762 0
Country [1] 304762 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304928 0
Hollywood Private Hospital Research Ethics Committee
Ethics committee address [1] 304928 0
101 Monash Ave, Nedlands WA 6009
Ethics committee country [1] 304928 0
Australia
Date submitted for ethics approval [1] 304928 0
Approval date [1] 304928 0
21/01/2019
Ethics approval number [1] 304928 0
HPH 536

Summary
Brief summary
Hip replacement demand continues to rise with the ageing population. There are several surgical approaches to perform hip replacement. The posterior approach is the most commonly performed approach, with several variations. Recently, there has been an increasing interest in the Direct Anterior Approach, due to the belief that it may result in decreased pain, faster recovery, improved hip stability and decreased risk of dislocation. Whilst some small early studies have reported decreased narcotic consumption, shorter length of stay and earlier independent mobilization; other have suggested increased rates of persistent pain, increased dislocation rates, component malposition and a comparable dislocation rate. Most studies already described in the medical literature are small numbers <50 patients and have short follow-up (<1year )
The aim of our study is to determine the long term patient outcomes and complication profile for the direct anterior approach in Total Hip Replacement using a large cohort.
Hip function, hip pain, walking aid use, complications and patient satisfaction will be assessed by means of a patient survey completed 2 year and 5 year anniversary of their surgery. The survey will take approximately 10 minutes to complete and may be returned electronically or via reply paid envelope.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98666 0
Dr Praveen Vasantharao
Address 98666 0
The Joint Studio
Suite 1/85 Monash Ave, Nedlands WA 6009
Country 98666 0
Australia
Phone 98666 0
+61 893863933
Fax 98666 0
Email 98666 0
[email protected]
Contact person for public queries
Name 98667 0
Dr Praveen Vasantharao
Address 98667 0
The Joint Studio
Suite 1/85 Monash Ave, Nedlands WA 6009
Country 98667 0
Australia
Phone 98667 0
+61 893863933
Fax 98667 0
Email 98667 0
[email protected]
Contact person for scientific queries
Name 98668 0
Dr Praveen Vasantharao
Address 98668 0
The Joint Studio
Suite 1/85 Monash Ave, Nedlands WA 6009
Country 98668 0
Australia
Phone 98668 0
+61 893863933
Fax 98668 0
Email 98668 0
[email protected]

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


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.