Pelvic operation for bone impingement
| ISRCTN | ISRCTN83250251 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83250251 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Ortopedicka klinika FNB |
| Funder | Investigator initiated and funded |
- 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
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
Principal investigator
Křižíkova 66
Praha 8
186 00
Czech Republic
 ORCID ID |
0000-0002-1855-084X |
|---|---|
| Phone | +420 (0)603 338 344 |
| smagersky@gmail.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-centre observational longitudinal case-control study |
| Secondary study design | Case-control study |
| Study type | Participant information sheet |
| Scientific title | Triple pelvic osteotomy in the treatment for pincer-type femoroacetabular impingement syndrome |
| Study objectives | The 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) studied | Femoroacetabular impingement (FAI) syndrome |
| Intervention | Eighteen 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 type | Procedure/Surgery |
| Primary outcome measure(s) |
1. Pain management measured with the Visual Analog Scale (VAS) before the operation and 1 year after the operation. |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 31/12/2020 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 18 |
| Total final enrolment | 18 |
| Key inclusion criteria | 1. 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 criteria | There are no exclusion criteria |
| Date of first enrolment | 15/01/2011 |
| Date of final enrolment | 20/12/2020 |
Locations
Countries of recruitment
- Czech Republic
Study participating centre
Prague 8
180 81
Czech Republic
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
09/05/2023: Trial's existence confirmed by the Faculty Hospital Bulovka Ethical Committee.
