Marker for FAI Diagnosis

Femoroacetabular Impingement Clinical Trial

— MarkerFAI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02880085
• Other study ID #: 07/15
• Status: Completed
• Phase: N/A
• First received: February 23, 2016
• Last updated: August 22, 2016
• Start date: February 2015
• Est. completion date: February 2016

Study information

• Verified date: August 2016
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Femoracetabular Impingement
• Femoroacetabular Impingement

Intervention

Drug:
• Local anesthetic
local injection

Locations

Country	Name	City	State
Italy	Laboratorio Tecnologia Medica	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Burnett 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. — View Citation

Kelly BT, Buly RL. Hip arthroscopy update. HSS J. 2005 Sep;1(1):40-8. doi: 10.1007/s11420-005-0105-3. — View Citation

Mintz 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. — View Citation

Philippon 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. Epub 2007 May 12. — View Citation

Simpson 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	1 year	Yes