Safety and Efficacy of i-FACTORTM Bone Graft in Anterior Cervical Discectomy and Fusion: A Prospective, Randomized, Controlled, Multi-Center, Investigational Device Exemption Study
Notice bibliographique
Résumé
Introduction The objective of the study was to evaluate i-FACTOR Putty and local autologous bone in a non-inferiority model when applied in instrumented ACDF using a structural allograft ring in subjects with cervical degenerative disc disease. I-FACTOR Putty is a composite bone graft material consisting of a synthetic peptide (P-15) adsorbed onto anorganic bone mineral (ABM). The P-15 fragment is a short chain peptide that mimics a cell binding domain of Type I collagen, that facilitates cell attraction, attachment and activation on the ABM scaffold. Material and Methods A prospective, randomized, controlled, multi-center trial was designed to investigate the safety and efficacy of i-FACTOR Putty against an autograft control group. The pre-determined statistical plan was that the i-FACTOR Putty was non-inferior to autologous bone. Twelve-month evaluations were considered to be the primary endpoint. Primary endpoints chosen for the purpose of this study included radiographic evidence of fusion, neurological, outcomes, functional outcomes, and assessment of complication rates. A blinded, independent third party was utilized to assess safety, radiologic outcomes, and neurologic outcomes. Adult patients with radiographic evidence of degenerative disc disease and with evidence of a history of arm/shoulder pain, decreased reflexes, decreased strength, and/or abnormal sensation were randomized for inclusion in this trial. Surgeons performed an anterior cervical discectomy. The control arm received an allograft ring filled with autologous bone. The investigational arm received an allograft ring filled with i-FACTOR Putty. Successful arthrodesis was based upon radiographic examinations and neck disability index (NDI) was scored as the absolute difference between the baseline and the 12-month scores. Neurological status was determined by comparing the preoperative status to maintenance or improvement over the twelve-month period. Adverse outcomes were also assessed. Overall success was judged by success in all primary endpoints. Results A total of 313 patients participated in the study (161 pts.-i-FACTOR Putty: 152 pts.-Autologous bone). Preoperative patient demographics were statistically similar in both populations. The study demonstrated the non-inferiority of i-FACTOR Putty compared with autologous bone for fusion status, change in NDI, and neurological success at 12 months. Fusion rates were 89% in the i-FACTOR Putty group and 86% in the Autologous bone group ( p = 0.0004 for non-inferiority test). NDI scores improved a mean of 29 points in the i-FACTOR Putty group and 27 points in the Autologous bone group ( p < 0.0001 for non-inferiority test). The neurological success rates was 94% in the i-FACTOR Putty group and 93% in the Autologous group ( p < 0.0001 for non-inferiority test). The proportion of subjects with any adverse event at 12 months was not different between both groups ( p = 0.8814). The overall success rate was significantly higher in the i-FACTOR Putty group than the Autologous bone group. The proportion of subjects who achieved fusion success, NDI success, neurological success, and safety success was 69% in the i-FACTOR Putty group and 58% in the Autologous bone group ( p = 0.0382). Conclusion In summary, the above data strongly support the safety and effectiveness of i-FACTOR Putty for its anticipated intended use. The i-FACTOR Putty subjects demonstrated a high rate of fusion, improvement in pain and function, similar adverse event rates to the Control group, and a low rate of subsequent surgeries or device-related adverse events.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».