OsteoporosisEVOLVENCT01613144
OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate
An observational study of Osteoporosis and Poor Bone Quality, run by Alphatec Spine, Inc. at 10 sites in 5 countries.
Trial summary
The purpose of this clinical investigation was to collect clinical evidence of the safety and efficacy of the OsseoScrew System. The OsseoScrew System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis, Poor Bone Quality
- What is being tested?
- OsseoScrew Spinal Fixation System
- Type of treatment
- Medical device
- How many people
- 94 participants
- Where
- 10 sitesin 5 countries
- Study dates
- May 2012to 8 Nov 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 150 skeletally mature study subjects with spinal instability and osteopenia will be enrolled in the study. Subjects will be randomized 1:1 to the OsseoScrew or the control group.
Who may be able to join
- ≥ 18 years of age
- Spinal instability or deformity requiring fusion with instrumentation
- Osteopenia defined as (T-Score of less than -1.0)
- No response to nonoperative treatment modalities preceding enrollment.
- Subject is willing and able to provide informed consent and agrees to release medical information for purposes of this study and to return for scheduled follow-up evaluations
Who cannot join
- Active systemic or local infection
- A life expectancy less than the study duration
- Autoimmune disorders
- Currently an alcohol, solvent, or drug abuser
- Psychiatric or cognitive impairment that, in the opinion of the investigator, would interfere with the subject's ability to comply with the study requirements
- History of allergies to any of the device components including but not limited to commercially pure titanium, titanium alloy, polymethylmethacrylate or Zirconium Oxide (ZrO2)
Trial locations and contacts
10 sites in 5 countries.
10 sites in 5 countries
Belgium4 sites
O.L. Vrouwziekenhuis
Aalst
CHIREC du Clinique
Brussels
ULB Hopital Erasme
Brussels
CHC St. Joseph
Liège
Germany2 sites
Katholisches Klinikum Koblenz - Montabaur/
Koblenz
University Medical Center Mainz/
Mainz
About this study
Official title: Expandable Pedicle Screws Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate (PMMA): Complications and Clinical Outcomes in Patients With Osteoporosis or Poor Bone Quality
The purpose of this clinical investigation was to collect clinical evidence of the safety and efficacy of the OsseoScrew System. The OsseoScrew System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The study was designed to compare the safety and efficacy of OsseoScrew compared to any other commercially available fenestrated pedicle screw system augmented with PMMA for posterior spinal fixation after surgical correction of spinal deformity or pathology.
Read the detailed description
This was a randomized, open-label, controlled, multi-center study in which patients were randomized in a 1:1 ratio to receive either the OsseoScrew or any commercially available fenestrated screw augmented with polymethylmethacrylate (PMMA) (Control group) for posterior spinal fixation after surgical correction of spinal deformity or pathology. The study was planned to include up to 150 skeletally mature patients with spinal instability and osteopenia at up to 10 sites. Patients were to return postoperatively at 6 weeks (± 2 weeks) and at 6, 12, and 24 months (± 2 months) for assessments.
- Conditions
- Osteoporosis, Poor Bone Quality
- Being tested
- OsseoScrew Spinal Fixation System
- Keywords
- Osteopenia, Stenosis, Instability, Tumor
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic, Constriction, Pathologic, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsseoScrew Spinal Fixation SystemDevice
Surgical intervention
| Study group | Role | What they receive |
|---|---|---|
| OsseoScrew | Test Product: OsseoScrew Spinal Fixation System Receives: Device: OsseoScrew Spinal Fixation System | |
| Fenestrated Screw | Control Product: Any commercially available fenestrated screw system augmented with PMMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoint: Rate of device-related or PMMA-related complications
The proportion of patients who were free from device-related or PMMA-related complications leading to revision, supplemental fixation, non-elective removal, or reoperation throughout the study. Complications included, but were not limited to device or PMMA fracture, device or PMMA-related loosening, device or PMMA-related device disassembly, device migration or PMMA extravasation.
Measured: 24 months
Efficacy Endpoint: Successful radiographic fusion
Presence of continuous bridging bone across the implant
Measured: 24 months
Secondary outcomes (3)
Oswestry Disability Index
This is a measure of the patient's self reported permanent functional disability. Each section is scored on a 1-5 scale with 5 representing the greatest disability.
Measured: 24 months
Visual Analogue Scale for back pain
This is a measure of the characteristic or attitude that is believed to range across a continuum of values to measure pain intensity. The range of score is from 0 - 100. The patient marks on the line the point that they feel represents their perception of their current state. A higher score indicates greater pain intensity.
Measured: 24 months
Adverse events
Adverse event rates
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startMay 2012
- Primary completion12 Feb 2017
- Study completion8 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alphatec Spine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bita Ghadimi, Study director, Alphatec Spine, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613144
- Sponsor's protocol ID
- REC-000784
- Acronym
- EVOLVE
- Status last verified
- Feb 2022
- First submitted
- 31 May 2012
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expandable Pedicle Screws Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate (PMMA): Complications and Clinical Outcomes in Patients With Osteoporosis or Poor Bone Quality
- ClinicalTrials.gov ID
- NCT01613144
- Acronym / sponsor ID
- EVOLVE / REC-000784
- Conditions
- Osteoporosis, Poor Bone Quality
- Keywords
- Osteopenia, Stenosis, Instability, Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Alphatec Spine, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- 12 Feb 2017 (actual)
- Study completion
- 8 Nov 2017 (actual)
- First posted
- 7 Jun 2012 (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 clinical investigation was to collect clinical evidence of the safety and efficacy of the OsseoScrew System. The OsseoScrew System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The study was designed to compare the safety and efficacy of OsseoScrew compared to any other commercially available fenestrated pedicle screw system augmented with PMMA for posterior spinal fixation after surgical correction of spinal deformity or pathology.
Detailed description
This was a randomized, open-label, controlled, multi-center study in which patients were randomized in a 1:1 ratio to receive either the OsseoScrew or any commercially available fenestrated screw augmented with polymethylmethacrylate (PMMA) (Control group) for posterior spinal fixation after surgical correction of spinal deformity or pathology. The study was planned to include up to 150 skeletally mature patients with spinal instability and osteopenia at up to 10 sites. Patients were to return postoperatively at 6 weeks (± 2 weeks) and at 6, 12, and 24 months (± 2 months) for assessments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OsseoScrew | – | Device: OsseoScrew Spinal Fixation SystemTest Product: OsseoScrew Spinal Fixation System |
| Fenestrated Screw | – | –Control Product: Any commercially available fenestrated screw system augmented with PMMA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 150 skeletally mature study subjects with spinal instability and osteopenia will be enrolled in the study. Subjects will be randomized 1:1 to the OsseoScrew or the control group.
Key inclusion criteria (5 listed)
- ≥ 18 years of age
- Spinal instability or deformity requiring fusion with instrumentation
- Osteopenia defined as (T-Score of less than -1.0)
- No response to nonoperative treatment modalities preceding enrollment.
- Subject is willing and able to provide informed consent and agrees to release medical information for purposes of this study and to return for scheduled follow-up evaluations
Key exclusion criteria (6 listed)
- Active systemic or local infection
- A life expectancy less than the study duration
- Autoimmune disorders
- Currently an alcohol, solvent, or drug abuser
- Psychiatric or cognitive impairment that, in the opinion of the investigator, would interfere with the subject's ability to comply with the study requirements
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 |
|---|---|---|
| OsseoScrew Spinal Fixation SystemSurgical intervention | Device | OsseoScrew |
Primary outcome
Safety Endpoint: Rate of device-related or PMMA-related complications
Time frame: 24 months
The proportion of patients who were free from device-related or PMMA-related complications leading to revision, supplemental fixation, non-elective removal, or reoperation throughout the study. Complications included, but were not limited to device or PMMA fracture, device or PMMA-related loosening, device or PMMA-related device disassembly, device migration or PMMA extravasation.
Efficacy Endpoint: Successful radiographic fusion
Time frame: 24 months
Presence of continuous bridging bone across the implant
3 secondary outcomes
Oswestry Disability Index
Time frame: 24 months
Visual Analogue Scale for back pain
Time frame: 24 months
Adverse events
Time frame: 24 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 25 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Bita Ghadimi study director
Alphatec Spine, Inc.
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Poor Bone Quality, run by Alphatec Spine, Inc. at 10 sites in 5 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 5 inclusion and 6 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 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Belgium, Germany, Spain, Italy, United Kingdom. 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?
Safety Endpoint: Rate of device-related or PMMA-related complications (time frame: 24 months). The study lists 2 primary outcomes in all. 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 25 Feb 2022.