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Trial registered on ANZCTR


Registration number
ACTRN12618000652279
Ethics application status
Approved
Date submitted
22/03/2018
Date registered
24/04/2018
Date last updated
23/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised clinical trial assessing migration of uncemented primary total hip replacement stems, with and without autologous impaction bone grafting.
Scientific title
Randomised clinical trial assessing migration of uncemented primary total hip replacement stems, with and without autologous impaction bone grafting.
Secondary ID [1] 294430 0
Nil Known
Universal Trial Number (UTN)
U1111-1211-2991
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-inflammatory arthritis of the hip 307249 0
Inflammatory arthritis of the hip 307250 0
Condition category
Condition code
Surgery 306292 306292 0 0
Surgical techniques
Musculoskeletal 306614 306614 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Uncemented primary total hip replacement (THR) with autologous impaction bone grafting.

Description: Uncemented primary total hip replacement involves surgical resection of the proximal femur and replacement with a prosthetic joint. The prosthetic components are press-fitted into place as opposed to being cemented, hence "uncemented". This is the same technique as standard uncemented primary total hip replacement, with the additional process of impacting bone graft into the femoral canal prior to insertion and fitting of the femoral component. The bone graft is harvested from the resected femoral head.
Duration: This additional process of harvesting, preparing, and impacting the autologous bone graft accounts for an additional 3-4 minutes of operative time.
Bilateral Hips: Patients who went on to have a second contralateral THR received the same intervention as the first THR.
Intervention code [1] 300724 0
Treatment: Surgery
Comparator / control treatment
Uncemented primary total hip replacement involves surgical resection of the proximal femur and replacement with a prosthetic joint. The prosthetic components are press-fitted into place as opposed to being cemented, hence "uncemented".
Control group
Active

Outcomes
Primary outcome [1] 305294 0
Femoral component migration using radiostereometric analysis
Timepoint [1] 305294 0
2-years postoperatively
Secondary outcome [1] 344759 0
Postoperative proximal femoral bone density (using dual-energy X-ray absorptiometry)
Timepoint [1] 344759 0
2-years postoperatively
Secondary outcome [2] 344760 0
Function and quality of life (using Oxford Hip Score)
Timepoint [2] 344760 0
2-years postoperatively
Secondary outcome [3] 344761 0
Function and quality of life (using Short Form-12 Health Survey)
Timepoint [3] 344761 0
2-years postoperatively
Secondary outcome [4] 344762 0
Patient satisfaction with the surgical outcome was measured postoperatively on a 5-point scale, corresponding to the descriptors Very Dissatisfied, Dissatisfied, Neutral, Satisfied, and Very Satisfied.
Timepoint [4] 344762 0
2-years postoperatively
Secondary outcome [5] 344763 0
Hip pain (using visual rating scale)
Timepoint [5] 344763 0
2-years postoperatively

Eligibility
Key inclusion criteria
Inclusion Criteria
1. The individual clinically qualifies for total hip arthroplasty surgery based on physical examination and medical history.
2. The individual is diagnosed with an inflammatory or non inflammatory degenerative joint disease.
3. The individual has not had a previous total hip replacement or hip fusion of the affected hip joint.
4. The individual is physically and mentally willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation (i.e. not diagnosed with active significant psychiatric disorder, senile dementia, Alzheimer’s disease, presence of alcohol or substance abuse).
5. The individual is skeletally mature.
6. The individual has no plans to relocate to another geographic area before the completion of the study thus precluding scheduled follow-up.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
1. The individual is unable or unwilling to sign the Patient Informed Consent specific to this study.
2. The individual is less than 60 years of age.
3. The individual is classified as morbidly obese (body mass index 40 or greater).
4. The individual has an active infection within the considered hip joint.
5. Any condition where quality of bone graft from the femoral head is poor and therefore not able to be used (e.g. avascular necrosis).
6. The individual has a neuromuscular or neurosensory deficiency that limits the ability to evaluate the safety and effectiveness of the surgery.
7. The individual has a diagnosed systemic disease that would affect the subject’s welfare or overall outcome of the study (i.e. Paget's disease, renal osteodystrophy), is not immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
8. The individual is pregnant.
9. The individual is a prisoner.

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)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised 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
Sample size was determined by basing it on the experiences of previous researchers conducting similar trials.

Simple comparative statistical calculations were performed comparing mean values and standard deviation of each arm's variables, and the significance of any difference using t-tests.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
1/08/2013
Date of last participant enrolment
Anticipated
Actual
22/07/2015
Date of last data collection
Anticipated
22/07/2020
Actual
Sample size
Target
100
Accrual to date
Final
98
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 10465 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 22174 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 299060 0
Charities/Societies/Foundations
Name [1] 299060 0
Hollywood Private Hospital Research Foundation
Country [1] 299060 0
Australia
Primary sponsor type
Individual
Name
Riaz Khan
Address
Prof. Riaz Khan
The Joint Studio,
Suite 1/85 Monash Avenue,
Nedlands, Perth, WA,
Australia, 6009
Country
Australia
Secondary sponsor category [1] 298295 0
None
Name [1] 298295 0
Address [1] 298295 0
Country [1] 298295 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299993 0
Hollywood Private Hospital Research Ethics Committee
Ethics committee address [1] 299993 0
Hollywood Private Hospital, Monash Avenue, Nedlands, Perth, WA, Australia, 6009
Ethics committee country [1] 299993 0
Australia
Date submitted for ethics approval [1] 299993 0
31/10/2011
Approval date [1] 299993 0
14/08/2012
Ethics approval number [1] 299993 0
HPH336

Summary
Brief summary
Background
Uncemented stems in primary total hip replacement (THR) are increasingly popular. The purported benefits of uncemented primary THR relate to improved stability and less side effects of cement implantation. However, concerns remain with the use of uncemented press-fit stems in primary THR.

Methods
From 2013-15, a total of 98 consecutive participants (100 primary THR procedures) were inducted into a single-institution, single-blinded, randomised clinical trial assessing, with radiostereometric analysis, whether autologous impaction bone grafting in uncemented primary THR reduced femoral component migration compared with traditional uncemented primary THR technique. Secondary outcomes comparing the two techniques were postoperative proximal femoral bone density (using dual-energy X-ray absorptiometry), function and quality of life (using Oxford Hip Score and Short Form-12 Health Survey), patient satisfaction, and hip pain (using visual rating scale).

Results
There was no difference in femoral component stability between the Graft and No Graft Groups at 2-years (p>0.5). There was no difference in calcar resorption between the Graft and No Graft Groups at 2-years (p>0.16), with both groups experiencing calcar bone loss. There was no difference in patient-reported pain, quality of life, function, or satisfaction postoperatively between the Graft and No Graft Groups at 2-years (p>0.3), with both groups improving in all measures.

Conclusion
Autologous impaction bone grafting in uncemented primary THR has shown its short-term postoperative outcomes to be on par with traditional uncemented technique.
The next phase of research regarding this autologous impaction bone grafting technique will be to expand its application from Type-B femora into the elderly population with Type-C femora.
Trial website
Trial related presentations / publications
1-year data analysis presented at:
Australian Orthopaedic Association Western Australia Annual Scientific Meeting, Perth, Australia, 2015.

2-year data analysis presented at:
The European Federation of National Associations of Orthopaedics and Traumatology (EFORT) Conference, Vienna, Austria, 2017.
Public notes

Contacts
Principal investigator
Name 82198 0
Prof Riaz Khan
Address 82198 0
The Joint Studio, Suite 1/85 Monash Avenue, Nedlands, Perth, WA, Australia, 6009
Country 82198 0
Australia
Phone 82198 0
+61 8 9386 3933
Fax 82198 0
Email 82198 0
[email protected]
Contact person for public queries
Name 82199 0
Michael Rutherford
Address 82199 0
The Joint Studio, Suite 1/85 Monash Avenue, Nedlands, Perth, WA, Australia, 6009
Country 82199 0
Australia
Phone 82199 0
+61 8 9386 3933
Fax 82199 0
Email 82199 0
[email protected]
Contact person for scientific queries
Name 82200 0
Michael Rutherford
Address 82200 0
The Joint Studio, Suite 1/85 Monash Avenue, Nedlands, Perth, WA, Australia, 6009
Country 82200 0
Australia
Phone 82200 0
+61 8 9386 3933
Fax 82200 0
Email 82200 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
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4075Plain language summaryNo There was no difference in femoral component stabi... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRandomised clinical trial assessing migration of uncemented primary total hip replacement stems, with and without autologous impaction bone grafting.2019https://dx.doi.org/10.1007/s00264-019-04290-5
N.B. These documents automatically identified may not have been verified by the study sponsor.