Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000667415
Ethics application status
Approved
Date submitted
19/04/2025
Date registered
24/06/2025
Date last updated
24/06/2025
Date data sharing statement initially provided
24/06/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Use of the Porous Cups with Trabecular Metal Augments in Revision Hip Arthroplasty
Scientific title
Porous Cementless Cups Combined with Trabecular Metal Augments in Revision Hip Arthroplasty: Mid-Term Outcomes
Secondary ID [1] 314193 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Revision Hip Arthroplasty 337162 0
Acetabular Defect 337163 0
Aseptic Loosening 337164 0
Condition category
Condition code
Musculoskeletal 333580 333580 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is a retrospective analysis of prospectively collected clinical and radiological data from a departmental registry of patients who underwent revision total hip arthroplasty due to aseptic loosening and severe acetabular bone loss

The registry was maintained prospectively and included clinical cases of patients consecutively operated on in the 2nd Department of Large Joint Arthroplasty at the N.N. Priorov Center from 2016 to 2022. Porous acetabular components combined with trabecular metal augments were used.

Clinical and radiographic data were collected from the time of surgery and during standardized follow-up visits at 3 months, 1 year, 2 years, and 5 years. When in-person follow-up was not possible, remote assessment was conducted via telephone and review of submitted radiographs. Outcomes collected included Harris Hip Score (HHS), VAS, WOMAC, complications, implant survivorship, and radiological signs of loosening. The maximum follow-up duration was 9 years, with a mean follow-up of 4.9 years.
The current analysis of the dates was initiated in 2025 to evaluate mid-term outcomes (clinical scores, radiological assessment, complications, and implant survival).
Intervention code [1] 330856 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341156 0
Survivorship of implants
Timepoint [1] 341156 0
Data from patients who underwent revision total hip arthroplasty between 2016 and 2022 were included in the study. Follow-up assessments were conducted at fixed timepoints relative to surgery: at 3 months, 1 year, 2 years, 5 years after revision hip arthroplasty. Additional follow-up assessments were conducted up to 9 years post-implantation, with the most recent data collected in 2025. When in-person visits were not feasible, follow-up was completed via telephone interviews and radiographs submitted by patients. The mean follow-up duration of 4.9 years (±1.78), ranging from a minimum of 2.6 years to a maximum of 9 years
Primary outcome [2] 341613 0
Functional Outcome
Timepoint [2] 341613 0
Preoperative scores were collected prior to revision surgery and compared with postoperative scores assessed at standardized timepoints: 3 months, 1 year, 2 years, and 5 years after surgery. However, for the purposes of statistical analysis, the most recent follow-up data available for each patient—up to 2025—were used. These final assessments were obtained either during in-person visits or via remote follow-up, and included clinical scores VAS.
Primary outcome [3] 341157 0
Functional Outcome
Timepoint [3] 341157 0
Preoperative scores were collected prior to revision surgery and compared with postoperative scores assessed at standardized timepoints: 3 months, 1 year, 2 years, and 5 years after surgery. However, for the purposes of statistical analysis, the most recent follow-up data available for each patient—up to 2025—were used. These final assessments were obtained either during in-person visits or via remote follow-up, and included clinical scores HHS.
Secondary outcome [1] 448077 0
Functional Outcome
Timepoint [1] 448077 0
Preoperative scores were collected prior to revision surgery and compared with postoperative scores assessed at standardized timepoints: 3 months, 1 year, 2 years, and 5 years after surgery. However, for the purposes of statistical analysis, the most recent follow-up data available for each patient—up to 2025—were used. These final assessments were obtained either during in-person visits or via remote follow-up, and included clinical scores WOMAC.
Secondary outcome [2] 446523 0
Rate of postoperative complications: periprosthetic joint infection, dislocation, aseptic loosening, implant breakage, nerve injury, intraoperative arterial bleedion and re-revision surgery for any cause.
Timepoint [2] 446523 0
Complications were assessed postoperatively at standardized timepoints: 3 months, 1 year, 2 years, and 5 years after revision surgery. Additional follow-up assessments were conducted up to 9 years post-implantation, with the most recent data collected in 2025. When in-person visits were not possible, follow-up was completed via telephone interview and submitted radiographs.

Eligibility
Key inclusion criteria
Clinical cases of patients operated on in the 2nd Department of Large Joint Arthroplasty at the N.N. Priorov Center from 2016 to 2022, where porous acetabular components combined with trabecular metal augments were used.
Minimum age
26 Years
Maximum age
83 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other cases of patients operated on in the 2nd Department of Large Joint Arthroplasty at the N.N. Priorov Center, where other constructions (cages, 3D components) or porous acetabular cups without trabecular metal augments were used.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/04/2025
Date of last participant enrolment
Anticipated
Actual
10/04/2025
Date of last data collection
Anticipated
Actual
15/04/2025
Sample size
Target
69
Accrual to date
Final
69
Recruitment outside Australia
Country [1] 26984 0
Russian Federation
State/province [1] 26984 0

Funding & Sponsors
Funding source category [1] 318712 0
University
Name [1] 318712 0
Valencia Catholic University Saint Vincent Martyr
Country [1] 318712 0
Spain
Primary sponsor type
University
Name
Valencia Catholic University Saint Vincent Martyr
Address
Country
Spain
Secondary sponsor category [1] 321142 0
Hospital
Name [1] 321142 0
Priorov National Medical Research Center of Traumatology and Orthopedics
Address [1] 321142 0
Country [1] 321142 0
Russian Federation

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317317 0
The Ethics Committee at the Federal State Budgetary Institution "N.N. Priorov National Medical Research Center of Traumatology and Orthopedics" of the Ministry of Health of the Russian Federation,
Ethics committee address [1] 317317 0
Ethics committee country [1] 317317 0
Russian Federation
Date submitted for ethics approval [1] 317317 0
25/03/2025
Approval date [1] 317317 0
04/04/2025
Ethics approval number [1] 317317 0

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

Contacts
Principal investigator
Name 140678 0
Dr Egor Polevoi
Address 140678 0
Valencia Catholic University Saint Vincent Martyr, 46001 Valencia, Spain, C/ de Quevedo, 2
Country 140678 0
Spain
Phone 140678 0
+34689817822
Fax 140678 0
Email 140678 0
[email protected]
Contact person for public queries
Name 140679 0
Egor Polevoi
Address 140679 0
Valencia Catholic University Saint Vincent Martyr, 46001 Valencia, Spain, C/ de Quevedo, 2
Country 140679 0
Spain
Phone 140679 0
+34689817822
Fax 140679 0
Email 140679 0
[email protected]
Contact person for scientific queries
Name 140680 0
Egor Polevoi
Address 140680 0
Valencia Catholic University Saint Vincent Martyr, 46001 Valencia, Spain, C/ de Quevedo, 2
Country 140680 0
Spain
Phone 140680 0
+34689817822
Fax 140680 0
Email 140680 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
• Primary outcome(s)
• Safety data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Data may be shared upon reasonable request via email of principal investigator: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    Ethical Approval.pdf
Informed consent form    INFORMED CONSENT FORM FOR SURGICAL INTERVENTION.pdf
Study protocol    Study Plan.pdf


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.