Dynesys Spinal System Post Market 522 Study

Degenerative Spondylolisthesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01528072
• Other study ID #: CMU2010-10S
• Status: Terminated
• Phase: N/A
• Start date: March 2012
• Est. completion date: April 2017

Study information

• Verified date: January 2020
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 153
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Spondylolisthesis
• Pseudarthrosis
• Pseudoarthrosis
• Spondylolisthesis

Intervention

Device:
• Dynesys Spinal System
Dynesys Spinal System will be used for all subjects

Locations

Country	Name	City	State
United States	Greater Baltimore Medical Center	Baltimore	Maryland
United States	Pine Heights Medical Center	Baltimore	Maryland
United States	Neurological Surgery of Southern Ill	Belleville	Illinois
United States	Riverhills Healthcare, Inc	Cincinnati	Ohio
United States	Danville Orthopedics and Spine	Danville	Virginia
United States	NYU - Center for Musculoskeletal Care	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	OrthopaediCare	Willow Grove	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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