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SPIRA™-A 3D and HCT/p DBM vs. Medtronic Divergent™-L/Perimeter™ and Recombinant BMP-2

Primary Purpose

Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ALIF
Sponsored by
Camber Spine Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Disc Disease focused on measuring lumbar spinal fusion

Eligibility Criteria

22 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • skeletally mature adults
  • completed 6 month non-operative or conservative therapy
  • signed informed consent
  • back pain with radicular symptoms as evidenced by leg pain
  • Degenerative Disc Disease involving a single level between L2 and S1
  • subject willing to participate in study and follow protocol
  • subject willing to comply with Post-op management program

Exclusion Criteria:

  • systemic infection such as AIDS, HIV or Active hepatitis
  • autoimmune disease
  • significant metabolic disease that might compromise bone growth
  • history of malignancy
  • previous surgery for primary tumor, trauma or infection
  • subject requires 2 or more levels of fusion
  • previous spinal instrumentation or previous interbody fusion at involved level
  • spondylolisthesis of grade greater than/equal to 2

Sites / Locations

  • Rothman Orthopaedic InstitureRecruiting
  • Texas Back InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Spira-A with HCT/p DBM

Medtronic PEEK ALIF with Infuse

Arm Description

Single level Spira-A 3D printed Titanium ALIF Device with HCT/p DBM

Single level Medtronic Divergent-L/Perimeter PEEK ALIF Device with Recombinant Bone Morphogenic Protein-2 (Infuse)

Outcomes

Primary Outcome Measures

Radiographic Fusion
AP/Lateral, Flexion, Extension and CT radiographs
Radiographic Fusion
AP/Lateral, Flexion, Extension and CT radiographs
Radiographic Fusion
AP/Lateral, Flexion, Extension and CT radiographs

Secondary Outcome Measures

Oswestry Disability Index
Improvement in the ODI as measured by a minimum of a 15 point improvement
Back and Leg VAS
Improvement in the VAS as measured by a minimum of a 20 point improvement.
VR-12 Health Survey
Improvement in the VR-12 Health Survey as demonstrated by pre-op and post-op evaluation
PROMIS score
Change in the PROMIS score

Full Information

First Posted
September 17, 2020
Last Updated
September 23, 2020
Sponsor
Camber Spine Technologies
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1. Study Identification

Unique Protocol Identification Number
NCT04566874
Brief Title
SPIRA™-A 3D and HCT/p DBM vs. Medtronic Divergent™-L/Perimeter™ and Recombinant BMP-2
Official Title
SPIRA™-A 3D Printed Titanium Anterior Lumbar Interbody Fusion Device and HCT/p Demineralized Bone Matrix Versus Medtronic Divergent™-L/Perimeter™ PEEK Anterior Lumbar Interbody Fusion Device and Recombinant Bone Morphogenic Protein-2
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 13, 2020 (Actual)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Camber Spine Technologies

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A prospective, randomized, controlled clinical evaluation utilizing the SPIRA™ ALIF 3-D printed titanium interbody device with DBM vs a Medtronic PEEK ALIF interbody device with BMP
Detailed Description
This is a single blinded randomized 1:1, controlled, prospective clinical study to evaluate fusion status and patient reported outcomes in circumferential lumbar fusion between L2-S1 at a single level with posterior screw fixation (Camber Spine Orthros System) and anterior surgery consisting of one of the treatment groups: subjects treated with the SPIRA™-A Interbody Device and HCTP/p DBM or subjects treated with Medtronic Divergent-L or Perimeter™ PEEK ALIF Interbody Device and rhBMP-2 (6mg per level).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis, Scoliosis
Keywords
lumbar spinal fusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
single blind randomized 1:1
Masking
Participant
Masking Description
subjects will be blinded prior to surgery. Following surgery, maintaining masking may not be feasible as subjects will have access to medical records and/or radiographs.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spira-A with HCT/p DBM
Arm Type
Other
Arm Description
Single level Spira-A 3D printed Titanium ALIF Device with HCT/p DBM
Arm Title
Medtronic PEEK ALIF with Infuse
Arm Type
Active Comparator
Arm Description
Single level Medtronic Divergent-L/Perimeter PEEK ALIF Device with Recombinant Bone Morphogenic Protein-2 (Infuse)
Intervention Type
Device
Intervention Name(s)
ALIF
Intervention Description
Anterior Lumbar Interbody Fusion
Primary Outcome Measure Information:
Title
Radiographic Fusion
Description
AP/Lateral, Flexion, Extension and CT radiographs
Time Frame
6 months
Title
Radiographic Fusion
Description
AP/Lateral, Flexion, Extension and CT radiographs
Time Frame
12 months
Title
Radiographic Fusion
Description
AP/Lateral, Flexion, Extension and CT radiographs
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Oswestry Disability Index
Description
Improvement in the ODI as measured by a minimum of a 15 point improvement
Time Frame
up to and including 24 months
Title
Back and Leg VAS
Description
Improvement in the VAS as measured by a minimum of a 20 point improvement.
Time Frame
up to and including 24 months
Title
VR-12 Health Survey
Description
Improvement in the VR-12 Health Survey as demonstrated by pre-op and post-op evaluation
Time Frame
up to and including 24 months
Title
PROMIS score
Description
Change in the PROMIS score
Time Frame
up to and including 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: skeletally mature adults completed 6 month non-operative or conservative therapy signed informed consent back pain with radicular symptoms as evidenced by leg pain Degenerative Disc Disease involving a single level between L2 and S1 subject willing to participate in study and follow protocol subject willing to comply with Post-op management program Exclusion Criteria: systemic infection such as AIDS, HIV or Active hepatitis autoimmune disease significant metabolic disease that might compromise bone growth history of malignancy previous surgery for primary tumor, trauma or infection subject requires 2 or more levels of fusion previous spinal instrumentation or previous interbody fusion at involved level spondylolisthesis of grade greater than/equal to 2
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Donald W Guthner, BS
Phone
646.460.2984
Email
dguthner@cambermedtech.com
First Name & Middle Initial & Last Name or Official Title & Degree
Noel Hetrick
Email
nhetrick@cambermedtech.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kaye, MD
Organizational Affiliation
Rothman Orthopaedic Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rothman Orthopaedic Institure
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Kaye, MD
Facility Name
Texas Back Institute
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon Rusch, CCRC
Phone
972-608-5143
Email
srusch@texasback.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
data to be share with investigators only.

Learn more about this trial

SPIRA™-A 3D and HCT/p DBM vs. Medtronic Divergent™-L/Perimeter™ and Recombinant BMP-2

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