Femoro-acetabular ImpingementNCT05310240
Analysis of the Relevance of Radiologic Parameters on the Outcome After Hip Arthroscopy
An observational study of Femoro-acetabular Impingement and Hip Impingement Syndrome, run by Bezirkskrankenhaus St. Johann in Tirol at 1 site in Austria.
Trial summary
Joint-preserving surgery with arthroscopic techniques of the hip follows detailed radiological assessment including plain radiography of the hips and magnetic resonance arthrography (MRI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoro-acetabular Impingement, Hip Impingement Syndrome, Hip Disease
- What is being tested?
- Hip arthroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 810 participants
- Where
- 1 siteAustria
- Study dates
- 1 Feb 2022to 1 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 810 patients received hip arthroscopy at this institution. All of those patients received an magnetic resonance arthrography.
Who may be able to join
- Hip arthroscopy from 2013-2021 at this department.
Who cannot join
- Age below 18 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Prognostic Radiological Parameters on the Outcome After Hip Arthroscopy, a Cross-sectional Study
Joint-preserving surgery with arthroscopic techniques of the hip follows detailed radiological assessment including plain radiography of the hips and magnetic resonance arthrography (MRI). The purpose of this study was to compare features on radiography and MRI of the hip before surgery and assess their prognostic value on the outcome after surgery.
Read the detailed description
Hip arthroscopy is indicated for the treatment of a variety of pathologies of the hip, in patients without osteoarthritis. The diagnosis in patients with pain at the hip is made after history taking, clinical examination and radiological evaluation with plain radiography in a standardized technique and a magnetic resonance arthrography of the hip. The main indications for hip arthroscopy include CAM-type femoroacetabular impingement (FAI) necessitating bony decompression and chondro-labral tears necessitating arthroscopic repair or debridement. The purpose of this radiological non-interventional outcome study was to assess features on plain radiography and MRI in favor of good outcome after hip arthroscopy.
This department performed 810 hip arthroscopies in the years of 2013 till 2021. All of those patients underwent standardized radiological evaluation with radiography and MRI. Radiographical parameters are assessed by a resident with experience in musculo-sceletal radiology, intra- and inter-observer reliability has been assessed for each parameter. All arthroscopies have been performed by two experience senior orthopedic surgeons. Ethical board approval has been obtained to follow-up on those patients. Follow-up includes the patient-reported outcome assessment using the iHOT12 score and the modified Harris hip score. The clinical end-point is the time till total hip arthroplasty (THA), a registry analysis of the Tyrolean Arthroplasty registry (TAR) has been performed. Statistical analysis is performed using ANOVA and Fishers T-Tests, the level of significance is .05.
- Being tested
- Hip arthroscopy
- Keywords
- magnetic resonance arthrography, hip arthroscopy
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip arthroscopyProcedure or surgery
Arthroscopic surgery of the hip
| Study group | Role | What they receive |
|---|---|---|
| Hip arthroscopy | Patients that underwent hip arthroscopy at this department between 2013 and 2021. Receives: Procedure: Hip arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
prosthetic-free survival
The number of days between hip arthroscopy and total hip arthroplasty. This parameter is assessed with the help of a joint-replacement registry for all subjects.
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
iHOT12 Score
Patient reported outcome measurement with validation for patients after hip arthroscopy
Measured: Through study completion, an average of 1 year
modified Harris-Hip score
Patient reported outcome measurement with validation for failure of joint-preserving procedures
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start1 Feb 2022
- Primary completion1 Jan 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Femoro-acetabular ImpingementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 810 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezirkskrankenhaus St. Johann in Tirol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moritz Wagner, Bezirkskrankenhaus St. Johann in Tirol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310240
- Sponsor's protocol ID
- 1199/2021
- Status last verified
- Aug 2023
- First submitted
- 16 Mar 2022
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ross JR, Larson CM, Bedi A. Indications for Hip Arthroscopy. Sports Health. 2017 Sep/Oct;9(5):402-413. doi: 10.1177/1941738117712675. Epub 2017 Jul 5.
PubMed 28678628McCarthy JC, Glassner PJ. Correlation of magnetic resonance arthrography with revision hip arthroscopy. Clin Orthop Relat Res. 2013 Dec;471(12):4006-11. doi: 10.1007/s11999-013-3202-5. Epub 2013 Aug 1.
PubMed 23904247Wagner M, Lindtner RA, Schaller L, Schmaranzer F, Schmaranzer E, Vavron P, Endstrasser F, Brunner A. Hip arthroscopy with initial access to the peripheral compartment for femoroacetabular impingement: midterm results from a large-scale patient cohort. J Orthop Traumatol. 2024 May 24;25(1):29. doi: 10.1186/s10195-024-00770-6.
PubMed 38789896
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Prognostic Radiological Parameters on the Outcome After Hip Arthroscopy, a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05310240
- Acronym / sponsor ID
- 1199/2021
- Keywords
- magnetic resonance arthrography, hip arthroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 810 participants (actual)
- Lead sponsor
- Bezirkskrankenhaus St. Johann in TirolUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Joint-preserving surgery with arthroscopic techniques of the hip follows detailed radiological assessment including plain radiography of the hips and magnetic resonance arthrography (MRI). The purpose of this study was to compare features on radiography and MRI of the hip before surgery and assess their prognostic value on the outcome after surgery.
Detailed description
Hip arthroscopy is indicated for the treatment of a variety of pathologies of the hip, in patients without osteoarthritis. The diagnosis in patients with pain at the hip is made after history taking, clinical examination and radiological evaluation with plain radiography in a standardized technique and a magnetic resonance arthrography of the hip. The main indications for hip arthroscopy include CAM-type femoroacetabular impingement (FAI) necessitating bony decompression and chondro-labral tears necessitating arthroscopic repair or debridement. The purpose of this radiological non-interventional outcome study was to assess features on plain radiography and MRI in favor of good outcome after hip arthroscopy.
This department performed 810 hip arthroscopies in the years of 2013 till 2021. All of those patients underwent standardized radiological evaluation with radiography and MRI. Radiographical parameters are assessed by a resident with experience in musculo-sceletal radiology, intra- and inter-observer reliability has been assessed for each parameter. All arthroscopies have been performed by two experience senior orthopedic surgeons. Ethical board approval has been obtained to follow-up on those patients. Follow-up includes the patient-reported outcome assessment using the iHOT12 score and the modified Harris hip score. The clinical end-point is the time till total hip arthroplasty (THA), a registry analysis of the Tyrolean Arthroplasty registry (TAR) has been performed. Statistical analysis is performed using ANOVA and Fishers T-Tests, the level of significance is .05.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hip arthroscopy | – | Procedure: Hip arthroscopyPatients that underwent hip arthroscopy at this department between 2013 and 2021. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 810 patients received hip arthroscopy at this institution. All of those patients received an magnetic resonance arthrography.
Key inclusion criteria (1 listed)
- Hip arthroscopy from 2013-2021 at this department.
Key exclusion criteria (1 listed)
- Age below 18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hip arthroscopyArthroscopic surgery of the hip | Procedure or surgery | Hip arthroscopy |
Primary outcome
prosthetic-free survival
Time frame: Through study completion, an average of 1 year
The number of days between hip arthroscopy and total hip arthroplasty. This parameter is assessed with the help of a joint-replacement registry for all subjects.
2 secondary outcomes
iHOT12 Score
Time frame: Through study completion, an average of 1 year
modified Harris-Hip score
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Background: PubMed 28678628Ross JR, Larson CM, Bedi A. Indications for Hip Arthroscopy. Sports Health. 2017 Sep/Oct;9(5):402-413. doi: 10.1177/1941738117712675. Epub 2017 Jul 5.
- Background: PubMed 23904247McCarthy JC, Glassner PJ. Correlation of magnetic resonance arthrography with revision hip arthroscopy. Clin Orthop Relat Res. 2013 Dec;471(12):4006-11. doi: 10.1007/s11999-013-3202-5. Epub 2013 Aug 1.
- Derived from this study: PubMed 38789896Wagner M, Lindtner RA, Schaller L, Schmaranzer F, Schmaranzer E, Vavron P, Endstrasser F, Brunner A. Hip arthroscopy with initial access to the peripheral compartment for femoroacetabular impingement: midterm results from a large-scale patient cohort. J Orthop Traumatol. 2024 May 24;25(1):29. doi: 10.1186/s10195-024-00770-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoro-acetabular Impingement and Hip Impingement Syndrome, run by Bezirkskrankenhaus St. Johann in Tirol at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prosthetic-free survival (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05310240, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.