Clinical trial NCT02880085: Marker for FAI Diagnosis
Official title: Use of a Marker for Cartilage Damage to Differentiate the Diagnosis of Femural Acetabular Impingement From Extraarticular Pathologies.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femoroacetabular Impingement
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 male and female, age range 18-45 recovered for suspicious FAI

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of partecipants with positive FAI by diagnostic gold standard (anesthetic injection) and negative response of FAI by dosing markers.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Laboratorio Tecnologia Medica
Study officials:
References:
citation: Kelly BT, Buly RL. Hip arthroscopy update. HSS J. 2005 Sep;1(1):40-8. doi: 10.1007/s11420-005-0105-3.
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. doi: 10.1016/j.arthro.2004.12.011.
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. doi: 10.1007/s00167-007-0348-2. Epub 2007 May 12.
citation: 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. doi: 10.2106/JBJS.D.02806.
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.