Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001447145p
Ethics application status
Submitted, not yet approved
Date submitted
19/09/2019
Date registered
18/10/2019
Date last updated
24/07/2020
Date data sharing statement initially provided
18/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Screw versus no screw fixation on cup stability in Total Hip Replacement
Scientific title
Screw versus no screw fixation on 2-year Total Hip Arthroplasty cup stability: a randomised clinical trial
Secondary ID [1] 299355 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 314506 0
Condition category
Condition code
Musculoskeletal 312855 312855 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Screw fixation of a press fit uncemented cup by one of 2 experienced orthopaedic surgeons (> 15 years) at a single private hospital. This intervention will be delivered once at time of primary hip arthroplasty. This surgery generally takes 60-90 minutes to perform.
Intervention code [1] 315622 0
Treatment: Surgery
Comparator / control treatment
Screwless fixation of a press fit uncemented cup by one of 2 experienced orthopaedic surgeons (> 15 years) at a single private hospital. This intervention will be delivered once at time of primary hip arthroplasty.
Control group
Active

Outcomes
Primary outcome [1] 321461 0
cup stability via radiostereometric analysis
Timepoint [1] 321461 0
1 week, 3, 12 and 24 months post-operative
24 months is the primary timepoint
Secondary outcome [1] 375052 0
Hip Pain via Numerical Rating score (0-10)
Timepoint [1] 375052 0
preoperative, 3, 12 and 24 months.
2 years post-operative is the primary timepoint
Secondary outcome [2] 375053 0
Hip function via Oxford hip score (0-48 best)
Timepoint [2] 375053 0
preoperative, 3, 12 and 24 months.
2 Years post-operative is the primary timepoint

Eligibility
Key inclusion criteria
1. consenting male and female patients
2. aged 50 to 75-years
3. degenerative native hip-joint pathology
4. adequate acetabular and femoral bone stock for uncemented fixation
Minimum age
50 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. local hip joint infection or significant systemic disease
2. affected by neuromuscular or sensory pathology
3. immunosuppressed
4. morbidly obese (BMI higher than 40)
5. unable to comply with the postoperative follow-up investigations to be inducted into the study

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
2/12/2019
Actual
Date of last participant enrolment
Anticipated
30/06/2020
Actual
Date of last data collection
Anticipated
30/06/2022
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment outside Australia
Country [1] 21875 0
Sweden
State/province [1] 21875 0

Funding & Sponsors
Funding source category [1] 303868 0
Commercial sector/Industry
Name [1] 303868 0
Gruppo Bioimpianti Srl
Country [1] 303868 0
Italy
Primary sponsor type
Commercial sector/Industry
Name
Gruppo Bioimpianti Srl
Address
Via Liguria, 28, 20068 Bettola-Zeloforamagno MI, Italy
Country
Italy
Secondary sponsor category [1] 304011 0
None
Name [1] 304011 0
Address [1] 304011 0
Country [1] 304011 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304376 0
Ramsay Health Care
Ethics committee address [1] 304376 0
Hollywood Private Hospital Nedlands WA 6009
Ethics committee country [1] 304376 0
Australia
Date submitted for ethics approval [1] 304376 0
18/09/2019
Approval date [1] 304376 0
Ethics approval number [1] 304376 0

Summary
Brief summary
Primary fixation of the acetabular cup in total hip arthroplasty is vital for long-term stability. In cementless press-fit cups, this initial stability is achieved by the press-fit fixation. Additional primary fixation may be obtained by the use of extra screws. However, the value of additional screw fixation of press-fit acetabular cup implants on implant survival is questioned. We investigate if screw fixation is necessary when a GB DMD uncemented cup purposefully designed to enhance osseointegration is implanted. The specific objectives of this project are to
i) evaluate the migration profile of the GB DMD uncemented acetabular Cup at 3 months, 1 and 2 years
ii) compare quality of stability (using radiostereometric analysis) and clinical outcomes with screw verses no screw fixation at 2 years
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96742 0
Prof Riaz Khan
Address 96742 0
The Joint Studio
1/85 Monash Ave Nedlands WA 6009
Country 96742 0
Australia
Phone 96742 0
+61 89386 3933
Fax 96742 0
Email 96742 0
[email protected]
Contact person for public queries
Name 96743 0
Ms Samantha Haebich
Address 96743 0
The Joint Studio
1/85 Monash Ave Nedlands WA 6009
Country 96743 0
Australia
Phone 96743 0
+61 864609781
Fax 96743 0
Email 96743 0
[email protected]
Contact person for scientific queries
Name 96744 0
Prof Riaz Khan
Address 96744 0
The Joint Studio
1/85 Monash Ave Nedlands WA 6009
Country 96744 0
Australia
Phone 96744 0
+61 89386 3933
Fax 96744 0
Email 96744 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


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.