Dynesys Spinal System Post Market 522 Study

Post Market Surveillance for the Dynesys Spinal System, Assessing Safety and Fusion.

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.

Study Overview

• Status: Terminated
• Conditions: Degenerative Spondylolisthesis; Pseudoarthrosis
• Intervention / Treatment: Device: Dynesys Spinal System

Detailed Description

Study is meant to assess the safety and fusion rates following posterior lateral fusion with the Dynesys Spinal System.

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Belleville, Illinois, United States, 62226
      • Neurological Surgery of Southern Ill
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Greater Baltimore Medical Center
    • Baltimore, Maryland, United States, 21229
      • Pine Heights Medical Center
  • New York
    • New York, New York, United States, 10003
      • NYU - Center for Musculoskeletal Care
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Riverhills Healthcare, Inc
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19106
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
    • Willow Grove, Pennsylvania, United States, 19090
      • OrthopaediCare
  • Virginia
    • Danville, Virginia, United States, 24541
      • Danville Orthopedics and Spine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dynesys System; 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.	Device: Dynesys Spinal System; Dynesys Spinal System will be used for all subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months post surgery date

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Joel Batts, Zimmer Biomet Spine

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: February 2, 2012
• First Submitted That Met QC Criteria: February 6, 2012
• First Posted (Estimate): February 7, 2012

Study Record Updates

• Last Update Posted (Actual): January 29, 2020
• Last Update Submitted That Met QC Criteria: January 17, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: pseudoarthrosis; neurologic impairment; Dynesys Dynamic Stabilization System; Spondylolithesis; failed fusion
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Fractures, Ununited; Spondylolisthesis; Pseudarthrosis
• Other Study ID Numbers: CMU2010-10S

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED