Dynesys Spinal System Post Market 522 Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2017-04-30

Brief Summary

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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.

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Detailed Description

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

Conditions

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Degenerative Spondylolisthesis Pseudoarthrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Dynesys Spinal System

Intervention Type DEVICE

Dynesys Spinal System will be used for all subjects

Interventions

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Dynesys Spinal System

Dynesys Spinal System will be used for all subjects

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No