Outcome Comparison of Allogenic Cancellous Bone and a New Synthetic Bone Substitute (geneX®) in Filling the Bone Defect Created With Medial Open Wedge High Tibial Osteotomy
Allogenic bone graft
+ Synthetic bone substitute (geneX®)
Arthrite+3
+ Maladies des Articulations
+ Maladies musculo-squelettiques
Étude thérapeutique
Résumé
Date de début de l'étude : 1 octobre 2013
Date à laquelle le premier participant a commencé l'étude.High tibial osteotomy is a well-established treatment option for the young patients (aged 40\~55years) with knee osteoarthritis which is confined in medial compartment of the knee. Classical technique was lateral closing wedge osteotomy, but recently medial open wedge osteotomy has gained popularity with the advent of new fixation devices and refined surgical techniques. The surgeon can correct the deformity more precisely in both coronal and sagittal planes simultaneously with medial opening technique. And it can avoid complications associated with lateral closing technique like tibial shaft offset or peroneal nerve palsy. But medial opening technique inevitably creates large bone defect, which has to be addressed to avoid complications like loss of correction or delayed/non-union. Autologous bone is widely accepted as a standard for filling bone defects, but its supply is limited and harvesting autologous bone adds to surgical morbidity like bleeding, pain or fracture at the donor site. Therefore, there has been much effort to find materials to substitute autologous bone. Many studies reported the results of using allogenic bone for addressing bone defects and most of them showed favorable results. But some allogenic bone products are cumbersome to process to make it fit to the defect, and there are potential risk of disease transmission, if the products are not properly treated. Bone cements of several different composition has been developed and when used for filling bone defect, they also showed good results in general. Recently, a new synthetic bone substitute based on calcium phosphate and calcium sulfate (geneX®, Biocomposites Co.,Ltd.) has been introduced and is commercially available. While providing initial mechanical strength, its calcium sulfate component is rapidly absorbed to provide space for new bone ingrowth and its surface is made to negatively charged, which helps accelerate new bone formation. It is provided as an injectable paste, which is easier to handle than allogenic bone, so it may help reduce operation time. With these theoretical advantages, there are some anecdotal reports that patients treated with geneX® presented less postoperative pain and bleeding than patients treated with allogenic bone graft. Therefore, we conducted this study to determine whether the new synthetic bone substitute (geneX®) is better than allogenic bone for addressing bone defect created in medial open wedge high tibial osteotomy.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.60 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
Comparateur actifGroupe II
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
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Joint Reconstruction Center, Seoul National University Bundang Hospital
Seongnam-si, South KoreaOuvrir Joint Reconstruction Center, Seoul National University Bundang Hospital dans Google Maps