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Dynesys Spinal System Post Market 522 Study

Primary Purpose

Degenerative Spondylolisthesis, Pseudoarthrosis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dynesys Spinal System
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Spondylolisthesis focused on measuring Dynesys Dynamic Stabilization System, Spondylolithesis, pseudoarthrosis, neurologic impairment, failed fusion

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Skeletally mature between the ages of 20-80
  2. Candidate for posterior lateral fusion between T1-S1 with autograft
  3. Degenerative spondylolisthesis with evidence of neurologic impairment or failed previous fusion (pseudoarthrosis)
  4. Symptoms of leg and/or back pain
  5. Non-responsive to conservative/non-surgical treatment for at least three (3) months
  6. Must be willing and able to comply with study requirements; including complete necessary study paperwork and return for required follow-up visits

Exclusion Criteria:

  1. Active systemic or local infection
  2. Obesity
  3. Use of interbody device
  4. Pregnancy
  5. Mental illness
  6. Incarceration
  7. Alcohol or drug abuse
  8. Severe osteoporosis or osteopenia
  9. Use in the cervical spine
  10. Sensitivities/allergy to metals, polymers, polyethylene, polycarbonate urethane and polyethylene terephthalate
  11. Soft tissue deficit not allowing sound closure
  12. Any medical or physical condition that would preclude the potential benefit of spinal implant surgery
  13. Congenital abnormalities, tumors or other conditions that would prevent secure component fixation that has the potential to decrease the useful life of the device
  14. Active malignancy or other significant medical comorbidities
  15. Any medical or mental condition which would put the patient at high risk due to the severity of surgery
  16. Inadequate pedicles of the thoracic, lumbar and sacral vertebrae
  17. Patient unwilling or unable to follow postoperative instructions

Sites / Locations

  • Neurological Surgery of Southern Ill
  • Greater Baltimore Medical Center
  • Pine Heights Medical Center
  • NYU - Center for Musculoskeletal Care
  • Riverhills Healthcare, Inc
  • University of Pennsylvania
  • Allegheny General Hospital
  • OrthopaediCare
  • Danville Orthopedics and Spine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dynesys System

Arm Description

All patients will receive the Dynesys System and all patients will be compared to historical literature control. Dynesys Spinal System will be used for all subjects.

Outcomes

Primary Outcome Measures

Fusion Rates
Fusion was defined by meeting three criteria: rotation < 5° between motion segments on flexion-extension radiographs translation < 3 mm between motion segments on flexion-extension radiographs presence of bridging bone. Fusion assessment for each patient was categorized as one of the four defined outcomes: fused, not fused, partial fusion, or UA (unable to assess). Efficacy was confirmed by the achievement of fusion in the experimental group when compared to the rate established in a literature control.

Secondary Outcome Measures

Full Information

First Posted
February 2, 2012
Last Updated
January 17, 2020
Sponsor
Zimmer Biomet
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1. Study Identification

Unique Protocol Identification Number
NCT01528072
Brief Title
Dynesys Spinal System Post Market 522 Study
Official Title
Post Market Surveillance for the Dynesys Spinal System, Assessing Safety and Fusion.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Terminated at request of FDA
Study Start Date
March 2012 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the safety and fusion rates following posterior lateral fusion with the Dynesys Spinal System used as an adjunct to fusion and compare to literature control.
Detailed Description
Study is meant to assess the safety and fusion rates following posterior lateral fusion with the Dynesys Spinal System.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Spondylolisthesis, Pseudoarthrosis
Keywords
Dynesys Dynamic Stabilization System, Spondylolithesis, pseudoarthrosis, neurologic impairment, failed fusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dynesys System
Arm Type
Experimental
Arm Description
All patients will receive the Dynesys System and all patients will be compared to historical literature control. Dynesys Spinal System will be used for all subjects.
Intervention Type
Device
Intervention Name(s)
Dynesys Spinal System
Intervention Description
Dynesys Spinal System will be used for all subjects
Primary Outcome Measure Information:
Title
Fusion Rates
Description
Fusion was defined by meeting three criteria: rotation < 5° between motion segments on flexion-extension radiographs translation < 3 mm between motion segments on flexion-extension radiographs presence of bridging bone. Fusion assessment for each patient was categorized as one of the four defined outcomes: fused, not fused, partial fusion, or UA (unable to assess). Efficacy was confirmed by the achievement of fusion in the experimental group when compared to the rate established in a literature control.
Time Frame
24 months post surgery date

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Skeletally mature between the ages of 20-80 Candidate for posterior lateral fusion between T1-S1 with autograft Degenerative spondylolisthesis with evidence of neurologic impairment or failed previous fusion (pseudoarthrosis) Symptoms of leg and/or back pain Non-responsive to conservative/non-surgical treatment for at least three (3) months Must be willing and able to comply with study requirements; including complete necessary study paperwork and return for required follow-up visits Exclusion Criteria: Active systemic or local infection Obesity Use of interbody device Pregnancy Mental illness Incarceration Alcohol or drug abuse Severe osteoporosis or osteopenia Use in the cervical spine Sensitivities/allergy to metals, polymers, polyethylene, polycarbonate urethane and polyethylene terephthalate Soft tissue deficit not allowing sound closure Any medical or physical condition that would preclude the potential benefit of spinal implant surgery Congenital abnormalities, tumors or other conditions that would prevent secure component fixation that has the potential to decrease the useful life of the device Active malignancy or other significant medical comorbidities Any medical or mental condition which would put the patient at high risk due to the severity of surgery Inadequate pedicles of the thoracic, lumbar and sacral vertebrae Patient unwilling or unable to follow postoperative instructions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Batts
Organizational Affiliation
Zimmer Biomet Spine
Official's Role
Study Director
Facility Information:
Facility Name
Neurological Surgery of Southern Ill
City
Belleville
State/Province
Illinois
ZIP/Postal Code
62226
Country
United States
Facility Name
Greater Baltimore Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Pine Heights Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
NYU - Center for Musculoskeletal Care
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Riverhills Healthcare, Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
OrthopaediCare
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
Danville Orthopedics and Spine
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Dynesys Spinal System Post Market 522 Study

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