Completed

NCT Number: NCT02880085

Marker for FAI Diagnosis

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.

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Key information

Conditions

Femoroacetabular Impingement Femoracetabular Impingement Joint Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Laboratorio Tecnologia Medica

Bologna, Italy, 40136

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with clinical diagnosis of suspected FAI
Patients with clinical addressing to arthroscopy

Exclusion criteria

Patients referring articular rheumatic pathologies
Patients referring traumatic events in hip
Patients wearing other hip prosthesis

Treatment and study plan

Local anesthetic

Drug

local injection

Other names: Lidocaine

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

Use of a Marker for Cartilage Damage to Differentiate the Diagnosis of Femural Acetabular Impingement From Extraarticular Pathologies.

Acronym: MarkerFAI

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Aug 26, 2016
Registry last updated: Aug 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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