Spinal DeformityNCT01220505
Post Market Surveillance to Evaluate the Effectiveness the Polaris Deformity Spinal System
An observational study of Spinal Deformity, run by Zimmer Biomet at 6 sites in 2 countries.
Trial summary
The purpose of this Post Market Surveillance Validation is to document the performance and clinical outcomes of the Polaris Deformity Spinal System \& Trivium 3D Spinal Deformity Correction System. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Deformity
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 66 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Sep 2010to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All subjects with a spinal defomrity with a Risser score of a minimum of 3 where the physician has determined that the patient requires a spinal fusion of the thoracic or lumbar spine are eligible for entry into the post market surveillance.
Who may be able to join
- 200 subjects at 10 clinical centers.
- All subjects undergoing spinal fusion surgery between the levels of T1- Ilium (Thoracic 1 to Ilium)
- All subjects are skeletally mature with spinal deformity.
- Risser score must be ≥ 3.
- Subjects or their representative must be willing and able to give informed consent and assent (if applicable).
- Subjects who do not meet any of the following contraindications: spinal infection or inflammation, morbid obesity, mental illness, alcoholism, drug abuse, pregnancy, metal sensitivity, foreign body sensitivity, patients with inadequate tissue coverage over the operative site, open wounds local to the operative area, any case not described in the specific indications
Who cannot join
- Any subject who does not meet the inclusion criteria
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Children's Orthopedics of Atlanta
Atlanta, Georgia, 30342
Orthopedics for Kids, PC
Birmingham, Alabama, 35205
Orthopedics Indianapolis, P.C.
Indianapolis, Indiana, 46278
Loma Linda University
Loma Linda, California, 92354
Rochester Hills Orthopedics
Rochester Hills, Michigan, 48307
About this study
Official title: A Post Market Surveillance Validation to Evaluate the Effectiveness of the Following System: Polaris Deformity Spinal System
The purpose of this Post Market Surveillance Validation is to document the performance and clinical outcomes of the Polaris Deformity Spinal System \& Trivium 3D Spinal Deformity Correction System.
Read the detailed description
The purpose of this Post Market Surveillance Validation is to document the performance and clinical outcomes of the Polaris Deformity Spinal System \& Trivium 3D Spinal Deformity Correction System. We have extended the study tol collect further outcomes data at the 12 month time point.
- Conditions
- Spinal Deformity
- Being tested
- Surgery
- Keywords
- scoliosis, kyphosis, spinal deformity, curvature, lordosis
- Medical subject headings
- Scoliosis, Kyphosis, Lordosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Also called Polaris Deformity Spinal System, Trivium Deformtiy Correction System
All subjects will have spinal surgery between the levels of T1 and Ilium using the Polaris Deformity Spinal System
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of Deformity Correction
The primary outcome measure for this trial will be the percentage of subjects who have maintained their degree of deformity correction within 10% from immediate post-op to the 6 month follow-up visit.
Measured: 6 months
Secondary outcomes (1)
Decreased Operative Time
Comparison of Operative times vs. literature
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DeformityStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tammy Stinson, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220505
- Sponsor's protocol ID
- CS-058
- Status last verified
- Dec 2019
- First submitted
- 12 Oct 2010
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Market Surveillance Validation to Evaluate the Effectiveness of the Following System: Polaris Deformity Spinal System
- ClinicalTrials.gov ID
- NCT01220505
- Acronym / sponsor ID
- CS-058
- Conditions
- Spinal Deformity
- Keywords
- scoliosis, kyphosis, spinal deformity, curvature, lordosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 14 Oct 2010 (estimated)
- Results
- Not posted in the source record
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 Post Market Surveillance Validation is to document the performance and clinical outcomes of the Polaris Deformity Spinal System \& Trivium 3D Spinal Deformity Correction System.
Detailed description
The purpose of this Post Market Surveillance Validation is to document the performance and clinical outcomes of the Polaris Deformity Spinal System \& Trivium 3D Spinal Deformity Correction System. We have extended the study tol collect further outcomes data at the 12 month time point.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All subjects with a spinal defomrity with a Risser score of a minimum of 3 where the physician has determined that the patient requires a spinal fusion of the thoracic or lumbar spine are eligible for entry into the post market surveillance.
Key inclusion criteria (6 listed)
- 200 subjects at 10 clinical centers.
- All subjects undergoing spinal fusion surgery between the levels of T1- Ilium (Thoracic 1 to Ilium)
- All subjects are skeletally mature with spinal deformity.
- Risser score must be ≥ 3.
- Subjects or their representative must be willing and able to give informed consent and assent (if applicable).
Key exclusion criteria (1 listed)
- Any subject who does not meet the inclusion criteria
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 |
|---|---|---|
| SurgeryAlso: Polaris Deformity Spinal System, Trivium Deformtiy Correction SystemAll subjects will have spinal surgery between the levels of T1 and Ilium using the Polaris Deformity Spinal System | Procedure or surgery | – |
Primary outcome
Maintenance of Deformity Correction
Time frame: 6 months
The primary outcome measure for this trial will be the percentage of subjects who have maintained their degree of deformity correction within 10% from immediate post-op to the 6 month follow-up visit.
1 secondary outcome
Decreased Operative Time
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
- Individual participant dataSharing planned: Undecided
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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.
Tammy Stinson study director
Zimmer Biomet
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Deformity, run by Zimmer Biomet at 6 sites in 2 countries.
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 1 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: finished, as of the sponsor's last update on 19 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Puerto Rico. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maintenance of Deformity Correction (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2019.