ISRCTN ISRCTN83250251
DOI https://doi.org/10.1186/ISRCTN83250251
Submission date
04/05/2023
Registration date
14/05/2023
Last edited
12/05/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Femoroacetabular impingement (FAI) syndrome (where the hip joint is not shaped normally) is a dynamic cause of hip arthritis and is commonly diagnosed in young adults without any other causes of hip pain. Pincer-type FAI, which is discussed in this study, is typically present in active middle-aged females. The aim of this study was to evaluate a series of patients who were treated surgically for the pincer or combined type of FAI to assess their clinical and radiological results and the complications of their surgical treatment.

Who can participate?
Patients with pincer/combined type FAI who needed surgery

What does the study involve?
Patients who underwent surgery between 2011 and 2020 are followed up, including MRI scans.

What are the possible benefits and risks of participating?
The benefits are a complete range of motion in the hip after the operation without any pain. Risks are possible rear FAI sign (a clinical sign with patients with FAI) after the operation.

Where is the study run from?
Ortopedicka klinika FNB (Czech Republic)

When is the study starting and how long is it expected to run for?
January 2011 to December 2020

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Magersky Stepan, smagersky@gmail.com

Contact information

Dr Štěpán Magersky
Principal Investigator

Křižíkova 66
Praha 8
186 00
Czech Republic

ORCiD logoORCID ID 0000-0002-1855-084X
Phone +420 (0)603 338 344
Email smagersky@gmail.com

Study information

Study designSingle-centre observational longitudinal case-control study
Primary study designObservational
Secondary study designCase-control study
Study setting(s)Hospital, Medical and other records
Study typeTreatment
Scientific titleTriple pelvic osteotomy in the treatment for pincer-type femoroacetabular impingement syndrome
Study objectivesThe aim of this study was to evaluate our series of patients who were operated for pincer femoroacetabular impingement (FAI) or combined-type FAI, their clinical and radiological results, and complications of surgical treatment. It is hypothesized that redirection triple pelvic osteotomy will correct the retroversion of the acetabulum measured by MRI scan and improve clinical outcomes in our cohort of patients. It is expected that this change in the orientation of the acetabulum will not affect the joint arthritis in negative way.
Ethics approval(s)Approved 17/05/2022, Faculty Hospital Bulovka Ethical Committee (180 81, Prague 8, Czech Republic; +420 (0)26608 2717; bozena.zachovalova@bulovka.cz), ref: 16.5.2022/10A425/EK-Z
Health condition(s) or problem(s) studiedFemoroacetabular impingement (FAI) syndrome
InterventionEighteen patients diagnosed with pincer/combined type FAI received triple pelvic reverse osteotomy between 2011 and 2020 and were followed in a prospective study for clinical and radiological evaluation. The average age of the patients was 37.3 years (28.0-45.0). Middle-age follow-up was performed. MRI scans were used to see the exact retroversion of the acetabulum before and after surgery.
Intervention typeProcedure/Surgery
Primary outcome measure1. Pain management measured with the Visual Analog Scale (VAS) before the operation and 1 year after the operation.
2. Pain, function, absence of deformity, and range of motion measured with the Harris Hip Score (HHS) at 11/2011, 02/2016 and 04/2020
3. Pain, stiffness, and function measured with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) before and after the operation
Secondary outcome measuresThere are no secondary outcome measures
Overall study start date01/01/2011
Completion date31/12/2020

Eligibility

Participant type(s)Mixed
Age groupAdult
SexBoth
Target number of participants18
Total final enrolment18
Key inclusion criteria1. Patients diagnosed with pincer/combined type FAI
2. Received a reverse triple pelvic osteotomy for treatment of pincer/combined type FAI at the Orthopedic Clinic Faculty Hospital Bulovka in Prague between 2011 and 2020
Key exclusion criteriaThere are no exclusion criteria
Date of first enrolment15/01/2011
Date of final enrolment20/12/2020

Locations

Countries of recruitment

  • Czech Republic

Study participating centre

Bulovka Faculty Hospital
Budinova 2
Prague 8
180 81
Czech Republic

Sponsor information

Ortopedicka klinika FNB
Hospital/treatment centre

Budínova 2
Praha 8
180 81
Czech Republic

Phone +420 (0)603 338 344
Email smagersky@gmail.com

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/01/2024
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planPlanned publication
IPD sharing planThe datasets generated during and/or analysed during the current study are not expected to be made available due to a contradiction with the joint-preserving-surgery committee.

Editorial Notes

09/05/2023: Trial's existence confirmed by the Faculty Hospital Bulovka Ethical Committee.