Dynesys Spinal System Post Market 522 Study

Zimmer Biomet

Status: Terminated

Conditions: Degenerative Spondylolisthesis; Pseudoarthrosis

Treatments: Device: Dynesys Spinal System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01528072

CMU2010-10S

Details and patient eligibility

About

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.

Full description

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

Enrollment: 153 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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153 participants in 1 patient group

Dynesys System

Experimental group

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.

Treatment:

Device: Dynesys Spinal System