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Last Updated: 10/31/2025
A Randomized Clinical Study Evaluating the Safety of Regenn® Negative Pressure Therapy System in Orthopaedic Surgical Wound Management
Summary: The goal of this clinical trial is to evaluate the safety of the investigational device, Regenn® Negative Pressure Therapy System (Regenn® Therapy), a form of Negative Pressure Wound Therapy (NPWT), in the post-operative surgical wounds of patients undergoing lumbar spinal fusion surgeries. The main questions the study aims to answer are: * The device-related serious adverse event rate. * Patient ...
Safety and Clinical Performance Assessment of Bone Substitutes Used for Bone Voids Filling - A Post-Market Clinical Follow-Up
Summary: A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all TEKNIMED Bone Substitute range of products: CERAFORM, TRIHA+, NANOGEL, and all their private labels. TEKNIMED bone substitutes are legacy products, some marketed for more than 20 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical ...
A Prospective, Randomized, Multi-center Study to Assess the Performance of MagnEtOs Flex Matrix Mixed With Local Autograft Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented poSterolatEral Lumbar/Thoraco-lumbar Fusion (PLF)
Summary: This is a phase IV post-marketing study for MagnetOs Flex Matrix. MagnetOs Flex Matrix is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease and undergoing spinal fusion surgery. In this study, MagnetOs Flex Matrix will be used according to the latest U.S. Instructions For Use, specifically as a bone graft extender ...
A Prospective, Randomized, Multi-Center Study to Assess the Safety and Performance of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers (DBX or Grafton) Mixed With Local Autograft in Patients Undergoing One to Two-Level Instrumented Posterolateral Lumbar/Thoracolumbar Fusion (PLF)
Summary: This is a phase IV post-marketing study for MagnetOs Easypack Putty. MagnetOs Easypack Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease or spinal trauma undergoing spinal fusion surgery. In this study, MagnetOs Easypack Putty will be used according to the latest U.S. Instructions For Use, standalone in th...
MID-MIS Trail Protocol - Comparison of Clinical Outcomes, Complications Rate and Treatment Costs of Mini-TLIF and MIDLIF in the Treatment of Discogenic Low Back Pain
Summary: Background Degenerative disc disease (DDD) is the leading cause of lower back pain and disability, which prevalence increasing with age. When conservative treatment fails, surgical methods of spinal fusion are employed. Minimally invasive techniques, including minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) and midline lumbar interbody fusion (MIDLIF), have well-documented adv...
Surgical Outcomes and Complications of Posterior Spinal Fusion in Adolescent Idiopathic Scoliosis
Summary: Adolescent idiopathic scoliosis (AIS) is the most common form of scoliosis representing about 80-90% of all idiopathic scoliosis cases , characterized by lateral curvature of the spine of 10 degrees or more in children 10-18 years without underlaying cause . AIS affects 1-3% of adolescents globally . More common in females with a ratio of 8;1 (1) The exact cause of AIS remain unknown ,however it's...
Kids With Iron Deficiency and Scoliosis (KIDS) Study
Summary: This study is a randomized controlled trial of preoperative oral iron supplementation, to identify whether iron deficiency is a modifiable risk factor for adverse surgical outcomes such as red blood cell transfusion and diminished postoperative cognitive and physical capacity in adolescents undergoing scoliosis surgery. Research Question(s)/Hypothesis(es): Primary * Iron supplementation will reduc...
Phase II Trial of Abaloparatide vs. Placebo in Post-Menopausal Women and Abaloparatide in Men Receiving Initial Spinal Fusion Surgery
Summary: This is a prospective randomized, double-blinded, placebo-controlled, phase 2, 12-month pilot to study the efficacy of abaloparatide in postmenopausal women needing lumbar spinal fusion surgery. A total of 72 women with low bone mass who are scheduled to undergo spinal fusion surgery will be randomized 2:1 in a blinded fashion to receive either 80 mcg of abaloparatide subcutaneously (SC) every day...
Durability of Supplementary Rod Constructs-SuppleMentAry Rod Technique (SMART)-for Long-segment Posterior Instrumented Spinal Fusion Procedures: A Multicenter Retrospective Comparative Study With Dual-rod Constructs
Summary: This is a multicenter retrospective comparative cohort study. The index surgery for this study is primary or revision long-segment posterior thoracolumbar (TL) instrumented fusion using either a supplementary rod construct or a dual-rod construct. Eligible patients who already had index surgery, will be identified for enrollment through a review of medical records of the participating surgeons at ...
Evaluation of the Effect of Reiki on Pain After Spinal Fusion: A Comparative, Randomized, Pilot Study
Summary: This study involves patients undergoing lumbar spine surgery (lumbar arthrodesis). It compares the effects of Reiki, an energy-based therapy, with conventional approaches to relieve postoperative pain. The goal is to determine whether this non-drug method can help reduce pain, limit the use of painkillers, and enhance patient comfort during recovery.
Functional Reach Test as a Clinical Tool for Assessing Postural Balance Limits Among Adult Spinal Deformity Patients
Summary: Adult spinal deformity (ASD) is a common spinal condition that often impacts an individual's ability to stand and maintain an upright posture. Poor balance often limits an individual's ability to perform basic activities of daily life (ADL) and can lead to disability. Current considerations of correcting ASD to improve balance focus on the amount of sway that one exhibits during normal standing. H...
The Ailliance Post-Market Clinical Study: All enablIng technoLogies, bioLogics, IDS, And Core spiNe produCt collEction
Summary: The purpose of this clinical study is to collect performance and safety data for post-market Medtronic devices indicated for cranial and/or spinal indication(s). Subjects are enrolled and followed postoperatively to 24 months. The Ailliance clinical study is intended to collect data congruous with routine clinical care practices.
Last Updated: 10/31/2025