Marker for FAI Diagnosis

Status Completed

Clinical 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.

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02880085
Study type	Observational
Source	Istituto Ortopedico Rizzoli
Contact
Status	Completed
Phase	N/A
Start date	February 2015
Completion date	February 2016

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT03669471` - Muscular and Functional Performance in FAIS Patients
Not yet recruiting	`NCT05031390` - the Horsens Aarhus FemoroAcetabular Impingement Syndrome Training Pilot Study	N/A
Active, not recruiting	`NCT05025956` - Senolytic Agent Improve the Benefit of Platelet-Rich Plasma and Losartan	Phase 1/Phase 2
Withdrawn	`NCT02674113` - Regional Anesthesia in Hip Arthroscopy	N/A
Withdrawn	`NCT02260726` - Evaluation of Ultrasound for Detecting Hip Impingement	N/A
Recruiting	`NCT05391204` - Reproducibility of Strength Testing and Functional Testing of the Hip for the Return to Sport of Patients Activated by a Femoroacetabular Impingement: Comparison Between a Group of Patients and a Group of Healthy Controls	N/A
Active, not recruiting	`NCT03891563` - Prospective Evaluation of Sport Activity and the Development of Femoroacetabular Impingement in the Adolescent Hip
Active, not recruiting	`NCT04069507` - Healthy Hip Study: Conservative Management for Pre-arthritic Hip Disorders
Terminated	`NCT03278353` - Fulfillment of Expectations for Patients With FAI Syndrome	N/A
Terminated	`NCT03995290` - 3D Modeling to Improve Hip Arthroscopy Outcomes
Completed	`NCT06082271` - Comparative, Randomized Study on the Anti-inflammatory and Regenerative Efficacy of a New Medical Device (DM) Based on Hydrolyzed Collagen Peptides in Patients With Femoro-acetabular Impingement Undergoing Hip Arthroscopy	N/A
Recruiting	`NCT01621360` - Hip Arthroscopy Versus Conservative Management of Femoroacetabular Impingement	N/A
Completed	`NCT04980209` - The Feasibility and Application of Intraoperative Ultrasound to Evaluate Femoral Head Shaping
Enrolling by invitation	`NCT04988659` - Analysis of Gene Expression in Femoroacetabular Impingement (FAI)
Active, not recruiting	`NCT03494660` - SCP Hip Outcomes Study
Active, not recruiting	`NCT04822571` - Investigating the Reliability of Highly Dynamic 3D Motion Analysis Protocol in Adolescence and Adult Males	N/A
Withdrawn	`NCT02706756` - Conservative Intervention of Femoroacetabular Impingement Syndrome	N/A
Completed	`NCT01993615` - A Physical Therapy Program Versus Surgery for Femoroacetabular Impingement: Randomized Clinical Trial	N/A
Completed	`NCT01814124` - Conservative Management of Femoroacetabular Impingement	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Marker for FAI Diagnosis — MarkerFAI

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms