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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]

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

Inflammatory arthritis of the hip

Condition category

Condition code

Surgery

Surgical techniques

Musculoskeletal

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]

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]

Femoral component migration using radiostereometric analysis

Timepoint [1]

2-years postoperatively

Secondary outcome [1]

Postoperative proximal femoral bone density (using dual-energy X-ray absorptiometry)

Timepoint [1]

2-years postoperatively

Secondary outcome [2]

Function and quality of life (using Oxford Hip Score)

Timepoint [2]

2-years postoperatively

Secondary outcome [3]

Function and quality of life (using Short Form-12 Health Survey)

Timepoint [3]

2-years postoperatively

Secondary outcome [4]

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]

2-years postoperatively

Secondary outcome [5]

Hip pain (using visual rating scale)

Timepoint [5]

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?

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

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Hollywood Private Hospital - Nedlands

Recruitment postcode(s) [1]

6009 - Nedlands

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Hollywood Private Hospital Research Foundation

Address [1]

Hollywood Private Hospital
Monash Avenue
NEDLANDS WA 6009

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hollywood Private Hospital Research Ethics Committee

Ethics committee address [1]

Hollywood Private Hospital, Monash Avenue, Nedlands, Perth, WA, Australia, 6009

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

31/10/2011

Approval date [1]

14/08/2012

Ethics approval number [1]

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

Prof Riaz Khan

Address

The Joint Studio, Suite 1/85 Monash Avenue, Nedlands, Perth, WA, Australia, 6009

Country

Australia

Phone

+61 8 9386 3933

Fax

[email protected]

Contact person for public queries

Name

Michael Rutherford

Address

The Joint Studio, Suite 1/85 Monash Avenue, Nedlands, Perth, WA, Australia, 6009

Country

Australia

Phone

+61 8 9386 3933

Fax

[email protected]

Contact person for scientific queries

Name

Michael Rutherford

Address

The Joint Studio, Suite 1/85 Monash Avenue, Nedlands, Perth, WA, Australia, 6009

Country

Australia

Phone

+61 8 9386 3933

Fax

[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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		There was no difference in femoral component stabi... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Randomised clinical trial assessing migration of uncemented primary total hip replacement stems, with and without autologous impaction bone grafting.	2019	https://dx.doi.org/10.1007/s00264-019-04290-5

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically