NCT02300909

Brief Summary

Prospective evaluation of the safety and efficacy of dHACM on clinical outcomes in lumbar laminectomy and microdiscectomy patients as assessed by Oswestry Disability Index.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

August 23, 2018

Status Verified

August 1, 2018

Enrollment Period

3.6 years

First QC Date

November 18, 2014

Last Update Submit

August 22, 2018

Conditions

ScarringSpinal StenosisHerniated Disc

Outcome Measures

Primary Outcomes (1)

  • Oswestry Disability Index

    Patient Functional Outcomes Questionnaire

    2 years

Secondary Outcomes (5)

  • Re-operation (Number of patients having re-operation during study)

    2 years

  • Scar formation in revision cases

    2 years

  • Quality of Life (VAS Pain)

    2 years

  • Quality of Life (SF-36)

    2 years

  • Quality of Life

    2 years

Other Outcomes (1)

  • MRI findings in first 20 patients

    3 months post-op

Study Arms (2)

dHACM

EXPERIMENTAL

Lumbar Decompression Surgery or Microdiscectomy Surgery with Application of Dehydrated Human Amnion/Chorion Membrane (dHACM)

Procedure: Lumbar Decompression SurgeryProcedure: Microdiscectomy SurgeryOther: Dehydrated Human Amnion/Chorion Membrane (dHACM)

Surgery without dHACM

OTHER

Control Group - Lumbar Decompression Surgery or Microdiscectomy Surgery without application of dHACM

Procedure: Lumbar Decompression SurgeryProcedure: Microdiscectomy Surgery

Interventions

Lumbar Decompression SurgeryPROCEDURE

Lumbar Decompression Surgery

Surgery without dHACMdHACM
Microdiscectomy SurgeryPROCEDURE

Microdiscectomy Surgery

Surgery without dHACMdHACM
Dehydrated Human Amnion/Chorion Membrane (dHACM)OTHER

Application of Dehydrated Human Amnion/Chorion Membrane (dHACM)

dHACM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Are 18 (eighteen) years of age or older at the time of surgery.
  • Patients with single- or multi-level spinal stenosis undergoing open lumbar laminectomy, or patients with single-level herniated nucleus pulposus undergoing single-level lumbar microdiscectomy
  • Are willing and able to return for the scheduled follow-up visits, follow post operative instructions and undergo the required radiographic exams for up to 5 time points between 4 weeks and 24 months post-surgery (6 weeks ± 2 weeks, 12 weeks ± 2 weeks, 6 months ±1 month, 1 year±2 months, and 2 years ±2 months post-surgery), including one study MRI-scan at 12 weeks ±2 weeks for the first 20 patients enrolled.
  • Are willing and able to sign study specific informed consent.

You may not qualify if:

  • Non-English speaking patients
  • Non-surgical candidate defined as any patient deemed by the surgeon not to be a surgical candidate cannot participate for the following reasons: that patient does not meet indications for lumbar laminectomy or microdiscectomy surgery, patient has a contraindication to surgery such as medical comorbidities, pregnancy, etc.
  • Allergic to aminoglycoside antibiotics
  • Is a prisoner
  • Is involved in worker's compensation or other litigation relative to the spine injury
  • Has a history of drug or alcohol abuse within the last 12 months
  • Is currently participating in another drug or device clinical trial
  • Previous spinal surgery
  • History of deformity, mechanical instability, or spinal fusion requirement
  • History of hard- or soft-tissue spinal infection
  • Has signs or symptoms of any disease, such as autoimmune disease, which could result in allograft failure, or has experienced allograft failure in the past
  • Patients unable to undergo a MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

CicatrixSpinal StenosisIntervertebral Disc Displacement

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsSpinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, Anatomical

Study Officials

  • Alexander Hughes, MD

    Hospital for Special Surgery, New York

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2014

First Posted

November 25, 2014

Study Start

November 1, 2014

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

August 23, 2018

Record last verified: 2018-08

Locations

US(1)