Ultrasound guided injection with Collagen-based Medical Device: real-life evaluation of efficacy and safety in hip osteoarthritis.

Abstract

Data regarding the treatment of hip osteoarthritis (OA) with collagen-based extracellular bio-scaffolds are lacking. We evaluated the treatment of hip OA with ultrasound guided intraarticular injections of Collagen-based Medical Device(CMD). Forty-four patients with Kellgren-Lawrence grade (KLG) I or II were selected, and 20/44randomly selected patients (CMD group), were treated with 2 weekly consecutive ultrasound guided intraarticular injections ofCMD (MD-HIP, Guna S.p.a. Milan, Italy). An additional 24/44 patients were treated with oral non-steroidal anti-inflammatorydrugs (NSAIDs) daily (NSAIDs group). Clinical assessment, X-rays and ultrasound evaluation were performed at baseline,and after 1 month in both groups, and after 3 months in the CMD group. Outcome measures were general pain VAS (0-10), thewhole WOMAC score, and the WOMAC specific subscores. CMD and NSAIDs group were homogenous for age,gender, VAS pain and WOMAC scores. The CMD group had significant improvement of the VAS pain (p<0.0001), globalWOMAC score (p<0.0001) and WOMAC function (p<0.0001) from baseline to the 1st month, with further improvementfrom the 1st to the 3rd month (p<0,001; p<0.01; p<0.03, respectively). Significant improvement in WOMAC pain (p<0.0001)and WOMAC stiffness (p<0.0001) was detected at 1st month, with no significant change at 3rd month. In the NSAIDs groupsignificant improvement in WOMAC function was detected after 1 month (p=0.021) only. No adverse events were recorded inthe CMD and NSAIDs group. The ultrasound guided intraarticular hip injections of CMD resulted in significantimprovement in VAS pain and WOMAC scores compared to treatment with oral NSAIDs.