Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000131651
Ethics application status
Approved
Date submitted
29/01/2014
Date registered
4/02/2014
Date last updated
5/02/2020
Date data sharing statement initially provided
5/02/2020
Date results provided
5/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A Prospective Randomized Trial of the Direct Anterior Approach versus the Posterior Approach in Primary Total Hip Arthroplasty
Scientific title
A randomized trial comparing the anterior and posterior approaches in hip replacement surgery for patients having unilateral hip arthritis using a series of questionnaires to measure pre and post operative outcomes and differences.
Secondary ID [1] 284003 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the hip - outcomes following hip replacement surgery using the anterior and posterior approaches 291040 0
Condition category
Condition code
Surgery 291380 291380 0 0
Surgical techniques
Musculoskeletal 291421 291421 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomized into two groups to undergo hip replacement surgery via the anterior or posterior approach. Surgery will be performed by 2 senior orthopaedic surgeons at a single institution. Participants will be assessed pre and post-operatively up to 3 months post operatively using a series of questionnaires.

The anterior approach used utilizes a modified varient of the Hueter anterior approach. This surgery is expected to take between 1-2 hours to peform depending on complexity.
The incision is made 2cm posterior and 1cm distal to the anterior superior iliac spine (ASIS) and extended in a straight line distally and slightly posterior ending approximately 2cm anterior to the greater trochanter (GT)

The interval between Sartorius and tensor fascia lata (TFL) is palpated and then incised. The lateral femoral cutaneous nerve is identified and protected. TFL is then retracted laterally while Sartorius is retracted medially. The interval is then further developed through the interval between rectus femoris and gluteus medius until the lateral hip capsule can be palpated. Iliopsoas and rectus femoris are gently elevated and retracted medially to complete the exposure of the hip capsule.

The lateral circumflex vessels are then identified and ligated. Capsulotomy is then performed and the edges tagged, reflected and protected to allow for subsequent reconstruction.

The femoral neck is then cut and femoral head delivered. The femur is now externally rotated approximately 45 degrees to facilitate acetabular exposure Precautions are taken during external rotation to prevent fractures. Preparation of the acetabulum can now occur. The anterior musculature is retracted carefully to minimize soft tissue damage. Labral excision is completed and the inferior capsule band incised to facilitate liner placement. Reaming is done under direct vision and acetabular component trialling is done under radiographic guidance.

On completion of acetabular preparation, the femur is externally rotated to 90 degrees and the hip adducted and hyperextended. If there is inadequate exposure of the femur, release of obturator internus with piriformis can be performed.

Once exposure is adequate, the femur is then breached with a box cut and broached. Broaching is undertaken carefully to prevent proximal femur fractures, cortical perforation and excessive anteversion. Broaching is completed when the size matches that of the preoperative template. This is guided by feel and depth. The femoral components are then trialled guided by the pre-operative template and final broach size.

The hip reduced with internal rotation. Leg length, offset and stability are checked clinically and with the aid of the image intensifier. On meeting the parameters, the hip is then dislocated, trial components removed, prosthesis inserted and hip reduced. The capsular incision is now repaired. Haemostasis with diathermy or ligation is achieved prior to closure of the soft tissue and skin.
Intervention code [1] 288690 0
Treatment: Surgery
Comparator / control treatment
We will be comparing the anterior approach (intervention) with the posterior approach for primary hip replacement surgery (standard approach/comparator). The surgery is expected to take between 1-2 hours depending on complexity.

A 8-12 cm incision is made posterior to the greater trochanter. The gluteal fascia is split and the fibres of gluteus maximus are dissected to expose the short external rotators of the hip. The piriformis muscle is identified and the sciatic nerve palpated and protected. The hip joint capsule is then exposed through the incision and reflection of these muscles.

The femoral neck is cut at the templated level whilst the hip is in its anatomical position. The femoral head is removed. Acetabular preparation commences. The operative leg is flexed and externally rotated away from the operator. The labrum and soft tissue is removed from the acetabulum prior to reaming. Reaming is done under direct vision and considered complete when reaching good bone stock. Acetabular components are trialled and fitted.

Upon completion of acetabular fitting, femoral preparation can begin. Breaching and broaching of the femur is done under direct vision. Broaching again is considered complete when parameters are met. The femoral components are trialled and the hip reduced. Leg length, offset and stability are checked. Once satisfactory, trial components are removed and the prosthesis proper inserted. The posterior capsule and short rotators are repaired using non-absorbable sutures to reduce the risk of post-operative dislocation. Haemostasis is obtained prior to closure of the fascia, subcutaneous tissue and skin.
Control group
Active

Outcomes
Primary outcome [1] 291371 0
WOMAC
Timepoint [1] 291371 0
pre-operatively
2 weeks post operatively
6 weeks post operatively
12 weeks post operatively
1 year post operatively
2 years post operatively
5 years post operatively
Primary outcome [2] 291409 0
Oxford Hip Score
Timepoint [2] 291409 0
pre-operatively
2 weeks post operatively
6 weeks post operatively
12 weeks post operatively
1 year post operatively
2 years post operatively
5 years post operatively
Secondary outcome [1] 306619 0
Functional performance assessment pre and post total hip arthroplasty will be conducted with a 10 metre walk test.
Timepoint [1] 306619 0
pre-operatively
2 weeks post operatively
6 weeks post operatively
12 weeks post operatively
1 year post operatively
Secondary outcome [2] 306681 0
pre-operatively
2 weeks post operatively
6 weeks post operatively
12 weeks post operatively
1 year post operatively
2 years post operatively
5 years post operatively
Timepoint [2] 306681 0
pre-operatively
2 weeks post operatively
6 weeks post operatively
12 weeks post operatively
1 year post operatively
Secondary outcome [3] 306682 0
Radiographic prosthesis placement
Timepoint [3] 306682 0
pre-operatively
2 weeks post operatively
6 weeks post operatively
12 weeks post operatively
1 year post operatively
2 years post operatively
5 years post operatively
Secondary outcome [4] 306683 0
Clinical data - eg: Peri-operative data, Length of hospital stay and recovery, compilcations, analgesic use.

Complications - observed would potentially include common complications associated with hip replacement surgery such as superficial wound infection, Deep vein thrombosis, peri-prosthetic fracture, prosthesis dislocation rates, palsy/damage to the lateral cutaneous nerve of the thigh

Late presenting complications such peri prosthetic joint infection will also be observed if possible
Timepoint [4] 306683 0
Clinical data - eg: Peri-operative data, Length of hospital stay and recovery, compilcations, analgesic use. Complications - observed would potentially include common complications associated with hip replacement surgery such as superficial wound infection, Deep vein thrombosis, peri-prosthetic fracture, prosthesis dislocation rates, neuropraxia to the lateral cutaneous nerve of the thigh. Late presenting complications such peri prosthetic joint infection fractures and revision will also be observed up to 5 years post operatively.

Eligibility
Key inclusion criteria
Symptomatic unilateral hip arthritis
ASA 2-3
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Symptomatic bilateral hip arthritis
ASA>3

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/02/2014
Actual
18/02/2014
Date of last participant enrolment
Anticipated
Actual
13/01/2015
Date of last data collection
Anticipated
Actual
23/12/2019
Sample size
Target
70
Accrual to date
Final
73
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2022 0
Box Hill Hospital - Box Hill
Recruitment hospital [2] 2023 0
Maroondah Hospital - Ringwood East

Funding & Sponsors
Funding source category [1] 288628 0
Hospital
Name [1] 288628 0
Eastern Health
Country [1] 288628 0
Australia
Funding source category [2] 288629 0
Charities/Societies/Foundations
Name [2] 288629 0
Box Hill Golf Club
Country [2] 288629 0
Australia
Primary sponsor type
Hospital
Name
Eastern Health Orthopaedic Unit
Address
Orthopaedic Unit
Box Hill Hospital
Nelson Road
Box Hill VIC 3128
Country
Australia
Secondary sponsor category [1] 287336 0
None
Name [1] 287336 0
Address [1] 287336 0
Country [1] 287336 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290486 0
Eastern Health Office of Research and Ethics
Ethics committee address [1] 290486 0
Ethics committee country [1] 290486 0
Australia
Date submitted for ethics approval [1] 290486 0
29/10/2013
Approval date [1] 290486 0
18/12/2013
Ethics approval number [1] 290486 0
E11-1314

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

Contacts
Principal investigator
Name 45914 0
Dr Tze Ern Cheng
Address 45914 0
Eastern Health
5 Arnold Street
Box Hill
VIC 3128
Country 45914 0
Australia
Phone 45914 0
+61 1300 342 255
Fax 45914 0
Email 45914 0
[email protected]
Contact person for public queries
Name 45915 0
Tze Ern Cheng
Address 45915 0
Eastern Health
5 Arnold Street
Box Hill
VIC 3128
Country 45915 0
Australia
Phone 45915 0
+61 1300 342 255
Fax 45915 0
Email 45915 0
[email protected]
Contact person for scientific queries
Name 45916 0
Tze Ern Cheng
Address 45916 0
Eastern Health
5 Arnold Street
Box Hill
VIC 3128
Country 45916 0
Australia
Phone 45916 0
+61 1300 342 255
Fax 45916 0
Email 45916 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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
SourceTitleYear of PublicationDOI
EmbaseA Prospective Randomized Clinical Trial in Total Hip Arthroplasty-Comparing Early Results Between the Direct Anterior Approach and the Posterior Approach.2017https://dx.doi.org/10.1016/j.arth.2016.08.027
EmbaseNo difference in functional, radiographic, and survivorship outcomes between direct anterior or posterior approach THA: 5-year results of a randomized trial.2021https://dx.doi.org/10.1097/CORR.0000000000001855
N.B. These documents automatically identified may not have been verified by the study sponsor.