Matej Drobnič1,2, Francesca Vannini3, Elizaveta Kon4,5,6, Oliver Dulić7,8, Vaso Kecojević7, Bogdan Andor9, Nir Altschuler10, Dror Robinson11. 1. Department of Orthopedic Surgery, University Medical Centre Ljubljana, Zaloška ulica 9, SI-1000, Ljubljana, EU, Slovenia. matej.drobnic@mf.uni-lj.si. 2. Chair of Orthopedics, Medical Faculty, University of Ljubljana, Ljubljana, Slovenia. matej.drobnic@mf.uni-lj.si. 3. Clinic 1, Orthopedic Institute Rizzoli, Bologna University, Bologna, Italy. 4. Humanitas Clinical and Research Center - IRCCS, Milan, Italy. 5. Department of Biomedical Sciences, Humanitas University, Milan, Italy. 6. Department of Traumatology, Orthopedics and Disaster Surgery, Sechenov First Moscow State Medical University, Moscow, Russia. 7. Department for Orthopedic Surgery and Traumatology, Clinical Center of Vojvodina, Novi Sad, Serbia. 8. Medical Faculty, University of Novi Sad, Novi Sad, Serbia. 9. Department of Orthopedics, Victor Babes University of Medicine and Pharmacy, Timisoara, Romania. 10. CartiHeal, Kfar Saba, Israel. 11. Faculty of Medicine, Hasharon Hospital Affiliated to Tel Aviv University, Petah Tikwa, Israel.
Abstract
PURPOSE: The two year results of a multi-centre clinical trial were examined to evaluate surgical treatment of hallux rigidus using a novel, bi-phasic, biodegradable, and cell-free aragonite-based scaffold (Agili-C™, CartiHeal Ltd, Israel). METHODS: Twenty patients with moderate-to-severe hallux rigidus were recruited. After thorough metatarsophalangeal joint (MTPJ-1) debridement, the scaffolds were implanted into the defect centre. Eight patients received concomitant osteotomy. Treatment outcome was followed clinically (Pain VAS, FAAM-ADL, FAAM-Sport, AOFAS-HMIS, maximum active range of extension ROM-EXT, and flexion ROM-FLEX), and by medical imaging, at six month intervals for two years. Adverse events were recorded throughout the study follow-up period. RESULTS: Significant clinical improvement over time was observed in all evaluated parameters (screening to final evaluation averages: Pain VAS 59 to 26, FAAM-ADL 57 to 77, FAAM-Sport 39 to 66, AOFAS-HMIS 51 to 81, ROM-EXT 18° to 36°), except for ROM-FLEX. Radiographs showed stable MTPJ-1 width over the two years in 17/18 cases (94%). MRI demonstrated progressive implant biodegradation, coupled with articular cartilage and subchondral bone regeneration, with a repair tissue defect fill of 75-100% in 14/17 (82%) subjects at their final visit. Revision surgery with implant removal was performed in two patients. CONCLUSION: Bi-phasic, osteochondral, biodegradable, aragonite-based scaffold demonstrated positive clinical outcome and a good safety profile in the treatment of medium-to-advanced hallux rigidus. According to the medical imaging, this implant has the potential to restore the entire osteochondral unit of metatarsal head.
PURPOSE: The two year results of a multi-centre clinical trial were examined to evaluate surgical treatment of hallux rigidus using a novel, bi-phasic, biodegradable, and cell-free aragonite-based scaffold (Agili-C™, CartiHeal Ltd, Israel). METHODS: Twenty patients with moderate-to-severe hallux rigidus were recruited. After thorough metatarsophalangeal joint (MTPJ-1) debridement, the scaffolds were implanted into the defect centre. Eight patients received concomitant osteotomy. Treatment outcome was followed clinically (Pain VAS, FAAM-ADL, FAAM-Sport, AOFAS-HMIS, maximum active range of extension ROM-EXT, and flexion ROM-FLEX), and by medical imaging, at six month intervals for two years. Adverse events were recorded throughout the study follow-up period. RESULTS: Significant clinical improvement over time was observed in all evaluated parameters (screening to final evaluation averages: Pain VAS 59 to 26, FAAM-ADL 57 to 77, FAAM-Sport 39 to 66, AOFAS-HMIS 51 to 81, ROM-EXT 18° to 36°), except for ROM-FLEX. Radiographs showed stable MTPJ-1 width over the two years in 17/18 cases (94%). MRI demonstrated progressive implant biodegradation, coupled with articular cartilage and subchondral bone regeneration, with a repair tissue defect fill of 75-100% in 14/17 (82%) subjects at their final visit. Revision surgery with implant removal was performed in two patients. CONCLUSION: Bi-phasic, osteochondral, biodegradable, aragonite-based scaffold demonstrated positive clinical outcome and a good safety profile in the treatment of medium-to-advanced hallux rigidus. According to the medical imaging, this implant has the potential to restore the entire osteochondral unit of metatarsal head.
Authors: Robert D Stibolt; Harshadkumar A Patel; Eva J Lehtonen; Henry A DeBell; Andrew S Moon; Sameer Naranje; Ashish Shah Journal: Foot Ankle Spec Date: 2018-08-22
Authors: Eliezer Sidon; Ryan Rogero; Timothy Bell; Elizabeth McDonald; Rachel J Shakked; Daniel Fuchs; Joseph N Daniel; David I Pedowitz; Steven M Raikin Journal: Foot Ankle Int Date: 2019-07-16 Impact factor: 2.827