Clinical Trials Logo
  1. Home
  2. Spondylolisthesis
  3. NCT04684901

Effectiveness of AlloWrap® for the Reduction of Inflammation in ACDF Procedures

Spondylolisthesis Clinical Trial

Official title:
A Randomized, Controlled Study to Evaluate Effectiveness of AlloWrap® Amniotic Membrane for the Reduction of Post-Operative Soft Tissue Inflammation in Two-Level Anterior Cervical Discectomy and Fusion Procedures

Clinical Trial Summary

The primary objective of this study is to obtain evidence of the effectiveness of AlloWrap Amniotic Membrane in the reduction of soft tissue swelling in two-level ACDF procedures.

Clinical Trial Description

AlloWrap® is a dual sided human amniotic membrane, procured from consented human tissue donors who elect to have scheduled cesarean births. A Human Cells, Tissues, and Cellular and Tissue-Based Product (HCT/P) as defined by the United States Food and Drug Administration (FDA) 21 CFR Part 1271, AlloWrap® is intended to provide a biologic barrier following surgical repair. Designed to meet the clinical needs of the patient and practical needs of the clinical setting amniotic based surgical barriers have been shown to contain a natural balance of cytokines that can assist the body in reducing epidural fibrosis, inflammation, and infection at the surgical site. Using AlloWrap® as a surgical barrier may result in outcomes with less scaring, potentially reducing pain and assisting the patient in returning to normal functionality while potentially making revision dissections less complicated. The purpose of this clinical study is to evaluate the use of AlloWrap® Amniotic Membrane in ACDF procedures to obtain evidence of effectiveness, defined as the reduction, and the possible prevention, of complications associated with ACDF surgery such as odynophagia and/or dysphasia that result from soft tissue inflammation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04684901
Study type Interventional
Source AlloSource
Contact
Status Enrolling by invitation
Phase N/A
Start date January 18, 2021
Completion date January 2026
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03883022 - Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery N/A
Active, not recruiting NCT04542577 - PMCF Study on the Safety and Performance of PROSPACE 3D / PROSPACE 3D OBLIQUE / TSPACE 3D
Recruiting NCT04477447 - PMCF Study on the Safety and Performance of CESPACE 3D
Completed NCT02558621 - New Robotic Assistance System for Spinal Fusion Surgery N/A
Terminated NCT01461005 - A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System (DSS) N/A
Completed NCT00405691 - Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis Phase 3
Completed NCT00205101 - Clinical Outcome Study of the Triad Allograft for Posterior Lumbar Fusion
Enrolling by invitation NCT04204135 - The Course of Hip Flexion Weakness Following LLIF or ALIF
Recruiting NCT05238740 - Comparison of Standalone Anterior Lumbar Interbody Fusion (ALIF) L5/S1 Performed With Either rhBMP-2 or ViviGen® N/A
Completed NCT02966639 - Validation of Appropriateness Criteria for the Surgical Treatment of Lumbar Degenerative Spondylolisthesis
Not yet recruiting NCT02805985 - Post-market Surveillance Study of FLXfit™ TLIF Interbody Fusion Device N/A
Completed NCT02931279 - PASS OCT® Post-market Clinical Follow-up
Active, not recruiting NCT02057744 - MIS ReFRESH: Robotic vs. Freehand Minimally Invasive Spinal Surgeries
Completed NCT01711203 - The Addition of a Pilates Program for Short-Term Improvements in Patients With Spondylolysis or Spondylolisthesis N/A
Completed NCT00549913 - Study of 3 Doses of NeoFuse Combined With MasterGraft Granules in Subjects Requiring Posterolateral Lumbar Fusion (PLF) Phase 1/Phase 2
Terminated NCT00254852 - Evaluation of Radiographic and Patient Outcomes Following Lumbar Spine Fusion Using Demineralized Bone Matrix (DBM) Mixed With Autograft N/A
Terminated NCT00095095 - Lumbar Interbody Fusion Using the Telamon® Peek™ Versus the Telamon® Hydrosorb™ Fusion Device Phase 4
Active, not recruiting NCT03956537 - PMCF Neo Pedicle Screw and Cage Systems
Recruiting NCT05182489 - Adaptix RCT Evaluating Adaptix™ Versus PEEK Cages N/A
Completed NCT02884440 - Transverse Abdominis Plane Block for Anterior Approach Spine Surgery Phase 2