Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000745741
Ethics application status
Approved
Date submitted
23/01/2021
Date registered
24/05/2022
Date last updated
24/05/2022
Date data sharing statement initially provided
24/05/2022
Date results provided
24/05/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Emergency procedure applied to tackle the lack of sphericity after cutting the bone bed for cementless hip arthroplasty – the acetabular screw-cup system developed by Aesculap
Scientific title
Functional outcomes and post-operative complications of an emergency procedure applied to tackle the lack of sphericity after cutting the bone bed for cementless hip arthroplasty
Secondary ID [1] 303249 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip osteoarthritis 320429 0
Condition category
Condition code
Musculoskeletal 318322 318322 0 0
Osteoarthritis
Surgery 321472 321472 0 0
Surgical techniques

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The medical records of patients admitted to SPZOZ Uniwersytecki Szpital Kliniczny hospital between 1/01/2010 and 31/12/2021 will be reviewed. The examination will cover patients who have undergone cementless arthroplasty of the hip joint in whom perfect sphericity was not achieved during milling the socket for the acetabular component.
The duration of such an operation is approximately 2 hours.
The procedure is performed by a specialist in orthopedics and traumatology.
Intervention code [1] 323426 0
Diagnosis / Prognosis
Intervention code [2] 323427 0
Early Detection / Screening
Comparator / control treatment
Patients in whom spongy screws were used to stabilize the acetabulum.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326293 0
Hip joint function measured on the scale Harris Hip Score
Timepoint [1] 326293 0
The hip function will be assessed 6(primary timepoint) , 12, 18, and 24 months after surgery.
Secondary outcome [1] 390941 0
Hip joint function was also assessed on the HOOS scale.
Timepoint [1] 390941 0
Assessment of hip function will also be performed 12-24 months after surgery.
Secondary outcome [2] 404349 0
Septic loosening of the prosthesis using X-ray
Timepoint [2] 404349 0
On admission to hospital due to a complication.
Secondary outcome [3] 404350 0
aseptic loosening of the prosthesis using X-ray
Timepoint [3] 404350 0
On admission to hospital due to a complication.
Secondary outcome [4] 404351 0
Endoprosthesis luxation using X-ray
Timepoint [4] 404351 0
On admission to hospital due to a complication.

Eligibility
Key inclusion criteria
Adults scheduled for hip arthroplasty using a cementless press-fit cup in whom an intraoperative decision was made to use a screw cup as a rescue procedure
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Death of the patient or failure to consent to the test.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
The results are presented as a mean ± standard deviation (SD) or median and interquartile range for normally and non-normally distributed variables, respectively. The distribution of continuous values was assessed with the Shapiro-Wilk test. Depending on the variable’s distribution, t-test or Mann-Whitney U test were used for comparisons between independent groups. One-way ANOVA and Kruskal-Wallis test were used for comparisons of normally and non-normally distributed variables of three independent groups. Correlations were performed with Person or Spearman method. For comparisons of categorical variables Fisher test was used. Multiple linear regression analysis was performed.
An alpha level of p<0.05 was required for significance. Statistical analysis was performed with Statistica ver. 13.0 PL software and graphs were plotted with GraphPad Prism application ver. 6.01 for Windows.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2010
Date of last participant enrolment
Anticipated
Actual
31/12/2020
Date of last data collection
Anticipated
Actual
21/04/2022
Sample size
Target
100
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 23404 0
Poland
State/province [1] 23404 0
Lódzkie

Funding & Sponsors
Funding source category [1] 307658 0
Self funded/Unfunded
Name [1] 307658 0
Country [1] 307658 0
Primary sponsor type
University
Name
Medical University of Lodz
Address
al. .Tadeusza Kosciuszki 4 , 90-419 Lódz
Country
Poland
Secondary sponsor category [1] 308352 0
None
Name [1] 308352 0
Address [1] 308352 0
Country [1] 308352 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307696 0
KOMISJA BIOETYCZNA PRZY UNIWERSYTECIE MEDYCZNYM W LODZI
Ethics committee address [1] 307696 0
Ethics committee country [1] 307696 0
Poland
Date submitted for ethics approval [1] 307696 0
01/01/2009
Approval date [1] 307696 0
01/01/2010
Ethics approval number [1] 307696 0
RNN/250/19/KE

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

Contacts
Principal investigator
Name 108178 0
Dr Jan Poszepczynski
Address 108178 0
Tadeusza Kosciuszki 4 , 90-419 Lódz. Department of Orthopedics and Traumatology University Teaching Hospital of the Military Medical Academy.
Country 108178 0
Poland
Phone 108178 0
+0048426368328
Fax 108178 0
Email 108178 0
[email protected]
Contact person for public queries
Name 108179 0
Jan Poszepczynski
Address 108179 0
Tadeusza Kosciuszki 4 , 90-419 Lódz. Department of Orthopedics and Traumatology University Teaching Hospital of the Military Medical Academy.
Country 108179 0
Poland
Phone 108179 0
+0048426368328
Fax 108179 0
Email 108179 0
[email protected]
Contact person for scientific queries
Name 108180 0
Jan Poszepczynski
Address 108180 0
Tadeusza Kosciuszki 4 , 90-419 Lódz Department of Orthopedics and Traumatology University Teaching Hospital of the Military Medical Academy.
Country 108180 0
Poland
Phone 108180 0
+0048426368328
Fax 108180 0
Email 108180 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
Clarify that IPD will not be available according to this definition. Data enabling the identification of a specific patient will not be presented to the public.


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.