[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07217964":3,"trial-entities:NCT07217964":92,"trial-summary:NCT07217964":96},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":27,"interventions":30,"primary_outcomes":39,"secondary_outcomes":44,"sex":45,"minimum_age":46,"maximum_age":25,"healthy_volunteers":47,"eligibility_criteria":48,"std_ages":60,"locations":63,"central_contacts":72,"overall_officials":73,"references":77,"see_also_links":91},"NCT07217964","2024-2081","Natural Matrix Protein","Evaluating Natural Matrix Protein (NMP) in Lumbar Spinal Fusion","ENROLLING_BY_INVITATION","2027-09-17","2026-06","2026-06-08","2025-03-18","Hospital for Special Surgery, New York","OTHER",false,"This clinical study is a non-randomized, consecutive, single-center, retrospective-prospective investigation of patients who received NMP bioimplant (Induce Biologics, Tampa, FL) in lumbar spinal fusion procedures. The purpose of this study is to assess the radiographic, clinical, and safety outcomes of Natural Matrix Protein (NMP) as a graft alternative in lumbar fusion procedures.\n\nUtilizing the Hospital for Special Surgery's EPIC database under Institutional Review Board approval, all patients with symptomatic lumbar degenerative disc disease who failed conservative management at up to four vertebral levels between L1-S1 between February 2024 and December 2025 will be reviewed.\n\nThe inclusion criteria for the study will be adult patients (≥ 18 years old) who underwent lumbar fusion with an NMP graft and interbody cage. The exclusion criteria will include previous lumbar fusion attempts, active malignancy, concurrently under chemotherapy, active infection at time of surgery, mentally compromised, and trauma to the operated region. It is expected approximately 100 patients will fit the inclusion\u002Fexclusion criteria.\n\nThe objective of the study is to evaluate the clinical outcomes of the subjects treated with NMP","Retrospective Data Collection:\n\nPatient data was collected into a data sheet to collect specific elements that relate to safety and efficacy of the procedure utilizing this specific device system. The data elements of interest are:\n\nPatient Summary data (where appropriate: average, sd, range):\n\nSubject demographics Distribution of primary diagnoses\n\nSurgical Information:\n\nLength of constructs with note of non-contiguous constructs Levels treated Patient Assessments and Questionnaires prior to surgery Type and brand of interbody implant(s) used (if applicable) Induce and other bone graft materials used Adverse Events (defined in section 3.5) Description of adverse events Radiographic imaging at pre-operative, discharge, and follow-up time points of 6 months post-operatively (as available)\n\nProspective Data Collection:\n\nPatients will be consented at their 12 month follow-up to participate in the clinical study. Clinical and radiographic data will be collected.\n\n12 month radiographic data (SOC x-rays and CTs) Patient Assessment Questionnaires Surgeon Assessment of Patient Classification of any Secondary Surgical Procedures Adverse Events If patient has not achieved fusion, patient will be asked if they would be willing to follow-up at 24 months\n\nRadiographic Assessment Imaging assessments will be performed by an independent imaging reviewer. The reviewer will be a musculoskeletal radiologist. The reviewer will be trained on the schedule of imaging assessments and classification systems for performing each assessment. The reviewer will not have access to clinical outcome data. Plain lateral radiographs at baseline, immediate postoperative, 6-month follow-up, 1-year follow-up, and 2-year follow-up (if available) will be utilized. All radiological measurements will be made using Sectra IDS7 (Sectra AB, Linköping, Sweden).\n\nFusion status on radiographs will be graded at each treated segment from an analysis of three components: bridging bone between the vertebral bodies, angular motion, and translational motion. Fusion Status measured on radiographs was derived from the qualitative assessment of bridging bone and the quantitative assessments of angular and translational Motion and in accordance to FDA guidance. The following grading system was implemented:\n\nNot Fused: Absence of bridging bone from endplate to endplate in the intervertebral space, or angular motion \\> 3 degrees, or translational motion \\> 2 mm.\n\nFused: Presence of bridging bone from endplate to endplate in the intervertebral space, angular motion ≤ 3 degrees, and translational motion ≤ 2mm.\n\nRetrospective-prospectively collected data will be recorded from subject electronic medical records\n\nStudy enrollment consists of 100 consecutive subjects who have consented to the study.\n\nStatistical Analysis:\n\nA performance goal methodology will be utilized to assess the primary outcome of fusion rate compared to literature controls. A literature review was conducted to find appropriate comparative studies that had similar criteria for the assessment of fusion for the performance model. The following studies are 1 level and 2 level lumbar interbody fusion studies that we used as the comparators:\n\nFairbank J. Re: Zigler J, Delamarter R, Spivak J, et al. Results of the prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential fusion for the treatment of 1-level degenerative disc disease. Spine 2007;32:1155-62. Spine (Phila Pa 1976). 2007 Dec 1;32(25):2929-30; author reply 2930-1. doi: 10.1097\u002FBRS.0b013e31815b84ca. PMID: 18246024.\n\nDelamarter R, Zigler JE, Balderston RA, Cammisa FP, Goldstein JA, Spivak JM. Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement compared with circumferential arthrodesis for the treatment of two-level lumbar degenerative disc disease: results at twenty-four months.\n\nFrom this modelling, our primary outcome performance goal would be an 96% fusion rate with a confidence interval of 93-99%.\n\nSample size calculation A total sample of 101 patients is needed for this study to estimate a fusion rate of 0.96 with two-sided 95% confidence interval of (0.93,0.99).\n\nStatistical analysis plan Counts and percentages of fusion status will be summarized. 95% confidence interval for the proportion estimate will also be calculated. VAS satisfaction and ODI score will be summarized as mean and standard deviation, or median and IQR based on the distribution of them.",[19],"Degenerative Lumbar Spinal Conditions",[21,6,22,23],"Lumbar","Fusion","Allograft","OBSERVATIONAL",null,[],{"count":28,"type":29},100,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":37},"RADIATION","Radiographic Evaluation","surgical procedure",[36],"Adult patients (≥ 18 years old) who underwent lumbar fusion",[38],"Surgical",[40],{"measure":41,"description":42,"timeFrame":43},"Radiographs","Radiographic:\n\nImaging assessments will be performed by an independent imaging reviewer. The reviewer will be a musculoskeletal radiologist trained in the schedule of imaging assessments and classification systems for performing each assessment. The reviewer will not have access to clinical outcome data. Plain lateral radiographs at baseline, immediate postoperative, 6-month follow-up, and 1-year follow-up. All radiological measurements will be made using Sectra IDS7 (Sectra AB, Linköping, Sweden).\n\nFusion status on radiographs will be graded at each treated segment from an analysis of three components: bridging bone between the vertebral bodies, angular motion, and translational motion. Fusion Status measured on radiographs was derived from the qualitative assessment of bridging bone and the quantitative assessments of angular and translational Motion. The following grading system was implemented:\n\nNot Fused: Absence of bridging bone from endplate to endplate","From May 2025 until May 2027",[],"ALL","18 Years",true,{"inclusion":49,"exclusion":52,"raw_text":59},[50,51],"Patients experiencing symptomatic lumbar degenerative disc disease who failed conservative management at up to four vertebral levels between L1-S1 between February 2024 and December 2024.","Adult patients (≥ 18 years old) who underwent lumbar fusion with an NMP graft and interbody cage",[53,54,55,56,57,58],"Previous lumbar fusion attempts at the level of surgery (adjacent lumbar levels are acceptable)","Active Malignancy","Concurrently under chemotherapy","Active infection at time of surgery","Mentally compromised","Trauma to the operated region","Inclusion Criteria:\n\n* Patients experiencing symptomatic lumbar degenerative disc disease who failed conservative management at up to four vertebral levels between L1-S1 between February 2024 and December 2024.\n* Adult patients (≥ 18 years old) who underwent lumbar fusion with an NMP graft and interbody cage\n\nExclusion Criteria:\n\n* Previous lumbar fusion attempts at the level of surgery (adjacent lumbar levels are acceptable)\n* Active Malignancy\n* Concurrently under chemotherapy\n* Active infection at time of surgery\n* Mentally compromised\n* Trauma to the operated region",[61,62],"ADULT","OLDER_ADULT",[64],{"facility":65,"city":66,"state":66,"zip":67,"country":68,"geoPoint":69},"Hospital for Special Surgery","New York","10021","United States",{"lat":70,"lon":71},40.71427,-74.00597,[],[74],{"name":75,"affiliation":13,"role":76},"Celeste Abjornson, PhD","STUDY_DIRECTOR",[78,82,85,88],{"pmid":79,"type":80,"citation":81},"31561556","BACKGROUND","D'Souza M, Macdonald NA, Gendreau JL, Duddleston PJ, Feng AY, Ho AL. Graft Materials and Biologics for Spinal Interbody Fusion. Biomedicines. 2019 Sep 26;7(4):75. doi: 10.3390\u002Fbiomedicines7040075.",{"pmid":83,"type":80,"citation":84},"37071155","Rathbone J, Rackham M, Nielsen D, Lee SM, Hing W, Riar S, Scott-Young M. A systematic review of anterior lumbar interbody fusion (ALIF) versus posterior lumbar interbody fusion (PLIF), transforaminal lumbar interbody fusion (TLIF), posterolateral lumbar fusion (PLF). Eur Spine J. 2023 Jun;32(6):1911-1926. doi: 10.1007\u002Fs00586-023-07567-x. Epub 2023 Apr 18.",{"pmid":86,"type":80,"citation":87},"30074971","Martin BI, Mirza SK, Spina N, Spiker WR, Lawrence B, Brodke DS. Trends in Lumbar Fusion Procedure Rates and Associated Hospital Costs for Degenerative Spinal Diseases in the United States, 2004 to 2015. Spine (Phila Pa 1976). 2019 Mar 1;44(5):369-376. doi: 10.1097\u002FBRS.0000000000002822.",{"pmid":89,"type":80,"citation":90},"26378347","Fehlings MG, Tetreault L, Nater A, Choma T, Harrop J, Mroz T, Santaguida C, Smith JS. The Aging of the Global Population: The Changing Epidemiology of Disease and Spinal Disorders. Neurosurgery. 2015 Oct;77 Suppl 4:S1-5. doi: 10.1227\u002FNEU.0000000000000953.",[],{"nct_id":4,"conditions":93,"biomarkers":95},[94],"Lumbar Disc Degenerative Disorder",[],{"nct_id":4,"found":15,"summary":25,"prompt_version":25}]