Femoroacetabular ImpingementMarkerFAINCT02880085
Marker for FAI Diagnosis
An observational study of Femoroacetabular Impingement, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The diagnostic gold standard to differentiate FAI (femural acetabular impingement) from other muscular-tendinous pathologies is, actually, the injection of intra-articular anesthetic (lidocaine), with a pre- and post- evaluation of pain scale. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Femoroacetabular Impingement
- What is being tested?
- Local anesthetic
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2015to Feb 2016
- 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: 20 male and female, age range 18-45 recovered for suspicious FAI
Who may be able to join
- Patients with clinical diagnosis of suspected FAI
- Patients with clinical addressing to arthroscopy
Who cannot join
- Patients referring articular rheumatic pathologies
- Patients referring traumatic events in hip
- Patients wearing other hip prosthesis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of a Marker for Cartilage Damage to Differentiate the Diagnosis of Femural Acetabular Impingement From Extraarticular Pathologies.
The diagnostic gold standard to differentiate FAI (femural acetabular impingement) from other muscular-tendinous pathologies is, actually, the injection of intra-articular anesthetic (lidocaine), with a pre- and post- evaluation of pain scale.
If, after injection, the pain disappears, the pain is probably due to an articular problem (FAI). This kind of differential diagnosis test has a sensibility of 100% and a specificity of 81%.
C-terminal telopeptide of type II collagen (CTXII) as cartilage degradation index, could be a marker, simply detectable, to assess the healthy of the cartilage status and could be measured in serum and urine.
Read the detailed description
This study is observational-analytical and cross-sectional, because the same patient will receive both the diagnostic iter.
For the rules of Evidence-based Medicine (Brown et al., 2006), the definition of this study PICO is:
P (population)= all the patients with suspected FAI afferent to Orthopaedic-Traumatology and Prosthetic surgery and revisions of hip and knee implants
I (intervention)= enzyme-linked immunosorbent assay (ELISA) for C-terminal telopeptide of type II collagen (CTXII) in serum and urine
C (comparison)= intra-articular lidocaine injection
O (outcome)= sensibility/specificity of ELISA test
From a literature analysis the C-terminal telopeptide of type II collagen (CTXII) seem to be the best candidate for this kind of comparison. Some previous studies (Scarpellini et al, 2008) demonstrated that this marker could be used in this way, and, for this reason, the aim of this study is to investigate the sensibility and specificity of this marker in serum and urine, vs the actual diagnostic gold standard (anesthetic intra-articular injection).
If the marker will be equal or better than the actual gold standard, the clinical practice will have an improvement, because this kind of analysis is simply performing and less invasive for the patient.
The study will enroll 20 patients with suspected FAI between 18-45 years and of both the gender.
- Conditions
- Femoroacetabular Impingement
- Being tested
- Local anesthetic
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local anestheticDrug
Also called Lidocaine
local injection
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of partecipants with positive FAI by diagnostic gold standard (anesthetic injection) and negative response of FAI by dosing markers.
It will be valuated with ROCC curve of both the diagnostic protocols. The Diagnostic Gold standard (anesthetic injection) ascertains the presence of FAI when, after anesthetic injection, the measured pain considerably decreases or disappears, using tha VAS scale for pain. If the dosage of the markers will be higher of the assessed normal values in the cases of diagnosed FAI, with a higher or equal sensitivity and specificity (%), it will be demonstrated that this kind of diagnosis could be a good subtituite of the actual diagnostic gold standard (valuated with ROCC curve)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Femoroacetabular 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Tassinari, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880085
- Sponsor's protocol ID
- 07/15
- Acronym
- MarkerFAI
- Status last verified
- Aug 2016
- First submitted
- 23 Feb 2016
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kelly BT, Buly RL. Hip arthroscopy update. HSS J. 2005 Sep;1(1):40-8. doi: 10.1007/s11420-005-0105-3.
PubMed 18751808Mintz DN, Hooper T, Connell D, Buly R, Padgett DE, Potter HG. Magnetic resonance imaging of the hip: detection of labral and chondral abnormalities using noncontrast imaging. Arthroscopy. 2005 Apr;21(4):385-93. doi: 10.1016/j.arthro.2004.12.011.
PubMed 15800516Philippon MJ, Maxwell RB, Johnston TL, Schenker M, Briggs KK. Clinical presentation of femoroacetabular impingement. Knee Surg Sports Traumatol Arthrosc. 2007 Aug;15(8):1041-7. doi: 10.1007/s00167-007-0348-2. Epub 2007 May 12.
PubMed 17497126Burnett RS, Della Rocca GJ, Prather H, Curry M, Maloney WJ, Clohisy JC. Clinical presentation of patients with tears of the acetabular labrum. J Bone Joint Surg Am. 2006 Jul;88(7):1448-57. doi: 10.2106/JBJS.D.02806.
PubMed 16818969Simpson J, Sadri H, Villar R. Hip arthroscopy technique and complications. Orthop Traumatol Surg Res. 2010 Dec;96(8 Suppl):S68-76. doi: 10.1016/j.otsr.2010.09.010. Epub 2010 Oct 30.
PubMed 21036688
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Marker for Cartilage Damage to Differentiate the Diagnosis of Femural Acetabular Impingement From Extraarticular Pathologies.
- ClinicalTrials.gov ID
- NCT02880085
- Acronym / sponsor ID
- MarkerFAI / 07/15
- Conditions
- Femoroacetabular Impingement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 26 Aug 2016 (estimated)
- 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.
The diagnostic gold standard to differentiate FAI (femural acetabular impingement) from other muscular-tendinous pathologies is, actually, the injection of intra-articular anesthetic (lidocaine), with a pre- and post- evaluation of pain scale.
If, after injection, the pain disappears, the pain is probably due to an articular problem (FAI). This kind of differential diagnosis test has a sensibility of 100% and a specificity of 81%.
C-terminal telopeptide of type II collagen (CTXII) as cartilage degradation index, could be a marker, simply detectable, to assess the healthy of the cartilage status and could be measured in serum and urine.
Detailed description
This study is observational-analytical and cross-sectional, because the same patient will receive both the diagnostic iter.
For the rules of Evidence-based Medicine (Brown et al., 2006), the definition of this study PICO is:
P (population)= all the patients with suspected FAI afferent to Orthopaedic-Traumatology and Prosthetic surgery and revisions of hip and knee implants
I (intervention)= enzyme-linked immunosorbent assay (ELISA) for C-terminal telopeptide of type II collagen (CTXII) in serum and urine
C (comparison)= intra-articular lidocaine injection
O (outcome)= sensibility/specificity of ELISA test
From a literature analysis the C-terminal telopeptide of type II collagen (CTXII) seem to be the best candidate for this kind of comparison. Some previous studies (Scarpellini et al, 2008) demonstrated that this marker could be used in this way, and, for this reason, the aim of this study is to investigate the sensibility and specificity of this marker in serum and urine, vs the actual diagnostic gold standard (anesthetic intra-articular injection).
If the marker will be equal or better than the actual gold standard, the clinical practice will have an improvement, because this kind of analysis is simply performing and less invasive for the patient.
The study will enroll 20 patients with suspected FAI between 18-45 years and of both the gender.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 20 male and female, age range 18-45 recovered for suspicious FAI
Key inclusion criteria (2 listed)
- Patients with clinical diagnosis of suspected FAI
- Patients with clinical addressing to arthroscopy
Key exclusion criteria (3 listed)
- Patients referring articular rheumatic pathologies
- Patients referring traumatic events in hip
- Patients wearing other hip prosthesis
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 |
|---|---|---|
| Local anestheticAlso: Lidocainelocal injection | Drug | – |
Primary outcome
Number of partecipants with positive FAI by diagnostic gold standard (anesthetic injection) and negative response of FAI by dosing markers.
Time frame: 1 year
It will be valuated with ROCC curve of both the diagnostic protocols. The Diagnostic Gold standard (anesthetic injection) ascertains the presence of FAI when, after anesthetic injection, the measured pain considerably decreases or disappears, using tha VAS scale for pain. If the dosage of the markers will be higher of the assessed normal values in the cases of diagnosed FAI, with a higher or equal sensitivity and specificity (%), it will be demonstrated that this kind of diagnosis could be a good subtituite of the actual diagnostic gold standard (valuated with ROCC curve)
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 26 Aug 2016.
- Background: PubMed 18751808Kelly BT, Buly RL. Hip arthroscopy update. HSS J. 2005 Sep;1(1):40-8. doi: 10.1007/s11420-005-0105-3.
- Background: PubMed 15800516Mintz DN, Hooper T, Connell D, Buly R, Padgett DE, Potter HG. Magnetic resonance imaging of the hip: detection of labral and chondral abnormalities using noncontrast imaging. Arthroscopy. 2005 Apr;21(4):385-93. doi: 10.1016/j.arthro.2004.12.011.
- Background: PubMed 17497126Philippon MJ, Maxwell RB, Johnston TL, Schenker M, Briggs KK. Clinical presentation of femoroacetabular impingement. Knee Surg Sports Traumatol Arthrosc. 2007 Aug;15(8):1041-7. doi: 10.1007/s00167-007-0348-2. Epub 2007 May 12.
- Background: PubMed 16818969Burnett RS, Della Rocca GJ, Prather H, Curry M, Maloney WJ, Clohisy JC. Clinical presentation of patients with tears of the acetabular labrum. J Bone Joint Surg Am. 2006 Jul;88(7):1448-57. doi: 10.2106/JBJS.D.02806.
- Background: PubMed 21036688Simpson J, Sadri H, Villar R. Hip arthroscopy technique and complications. Orthop Traumatol Surg Res. 2010 Dec;96(8 Suppl):S68-76. doi: 10.1016/j.otsr.2010.09.010. Epub 2010 Oct 30.
- 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 Femoroacetabular Impingement, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 2 inclusion and 3 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 26 Aug 2016. 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 Italy. 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?
Number of partecipants with positive FAI by diagnostic gold standard (anesthetic injection) and negative response of FAI by dosing markers. (time frame: 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 NCT02880085, which also lists 5 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 26 Aug 2016; AzTrials last refreshed its copy on 30 Oct 2026.