Degenerative SpondylolisthesisNCT01528072

Dynesys Spinal System Post Market 522 Study

A study testing Dynesys Spinal System in people with Degenerative Spondylolisthesis and Pseudoarthrosis, run by Zimmer Biomet at 9 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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. Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Degenerative Spondylolisthesis, Pseudoarthrosis
What is being tested?: Dynesys Spinal System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 153 participants
Where: 9 sitesUnited States
Study dates: Mar 2012to Apr 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Active systemic or local infection
Obesity
Use of interbody device
Pregnancy
Mental illness
Incarceration

Show all 17Show fewer

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

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

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

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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

Conditions: Degenerative Spondylolisthesis, Pseudoarthrosis
Being tested: Dynesys Spinal System
Keywords: Dynesys Dynamic Stabilization System, Spondylolithesis, pseudoarthrosis, neurologic impairment, failed fusion
Medical subject headings: Pseudarthrosis, Spondylolisthesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dynesys Spinal SystemDevice
Dynesys Spinal System will be used for all subjects

Study groups in NCT01528072
Study group	Role	What they receive
Dynesys System	Experimental	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. Receives: Device: Dynesys Spinal System

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 24 months post surgery date

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2012Apr 2017

First posted7 Feb 2012 (estimated)
Study startMar 2012
Primary completionApr 2017
Study completionApr 2017

Why it stopped: Terminated at request of FDA

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Degenerative SpondylolisthesisStudies of the same condition, open and under way.
More trials run by Zimmer BiometThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 153 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01528072
Sponsor's protocol ID: CMU2010-10S
Status last verified: Jan 2020
First submitted: 2 Feb 2012
Last updated: 29 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Degenerative Spondylolisthesis trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post Market Surveillance for the Dynesys Spinal System, Assessing Safety and Fusion.
ClinicalTrials.gov ID: NCT01528072
Acronym / sponsor ID: CMU2010-10S
Conditions: Degenerative Spondylolisthesis, Pseudoarthrosis
Keywords: Dynesys Dynamic Stabilization System, Spondylolithesis, pseudoarthrosis, neurologic impairment, failed fusion
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated at request of FDA
Enrolment: 153 participants (actual)
Lead sponsor: Zimmer BiometIndustry (pharma, biotech, devices)
Study start: Mar 2012
Primary completion: Apr 2017 (actual)
Study completion: Apr 2017 (actual)
First posted: 7 Feb 2012 (estimated)
Results: Posted 29 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Dynesys System	Experimental	Device: Dynesys Spinal SystemAll 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.

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (17 listed)

Active systemic or local infection
Obesity
Use of interbody device
Pregnancy
Mental illness

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dynesys Spinal SystemDynesys Spinal System will be used for all subjects	Device	Dynesys System

Primary outcome

Fusion Rates
Time frame: 24 months post surgery date
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.

Results and safety

Results posted to the registry on 29 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dynesys System	140	66

Primary outcome: Fusion Rates

Time frame: 24 months post surgery date. Count of participants. Unit: Participants

Measure	Dynesys System n = 61
Proportion fused	33
Proportion not fused	19
Proportion with Partial Fusion	5
Proportion unable to assess	4

Population analysed: Sixty-six (66) out of the original 140 implanted subjects completed their 24 month follow up. Sixty-one (61) subjects completed 24month radiograph for analysis of the primary end point.

Adverse events

Time frame: Adverse events were collected from the time of surgery through the participants last visit; up to 48months.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dynesys System	33 of 139 (23.7%)	71 of 139 (51.1%)	2 of 139

Limitations and caveats (from the sponsor): Early termination lead to a significant subset of subjects to not make it to the final follow up time interval. This resulted in small numbers of subjects analyzed for fusion and literature control was not used as planned originally in protocol.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Degenerative Spondylolisthesis

Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Active, not recruiting
SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis
Recruiting
Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis
Degenerative Disc Disease, Spondylolisthesis
Active, not recruiting
The NORDSTEN Study - Degenerative Spondylolisthesis
Lumbar Degenerative Spondylolisthesis
Enrolling by invitationObservational study
The Course of Hip Flexion Weakness Following LLIF or ALIF
Degenerative Disc Disease, Herniated Nucleus Pulposus

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joel Batts study director

Zimmer Biomet Spine

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Dynesys Spinal System in people with Degenerative Spondylolisthesis and Pseudoarthrosis, run by Zimmer Biomet at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fusion Rates (time frame: 24 months post surgery date). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01528072.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020.