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

Part of paid clinical trials in San Diego, California.

Sponsor
AlloSource
Study ID
NCT04684901
Status
Enrolling By Invitation

Conditions

  • Cervical Disc Disorder
  • Cervical Radiculopathy
  • Cervical Stenosis
  • Spondylolisthesis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AlloWrap® Amniotic Membrane — OTHER
    AlloWrap is a human amniotic membrane designed to provide a biologic barrier following surgical repair.

Study Details

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.

Key Dates

Start date
Jan 18, 2021
Status verified
Nov 2025
Primary completion
Nov 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Standard of Care Group
    Standard of Care - No AlloWrap used during surgery
  • Experimental: AlloWrap Group
    AlloWrap used in surgery

Primary Outcome Measure

Swelling Index 1 Month [ Time Frame: 1 month ]

Locations (1)

FacilityCityStateZIPSite coordinators
Spine Institute of San DiegoSan DiegoCalifornia92120-

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Spine Institute of San Diego· San Diego, CA

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