Spine FusionNCT05001893
Clinical Safety and Efficacy of S53P4 Bioactive Glass Putty in Spinal Fusion Surgery
An observational study of Spine Fusion and Spinal Deformity, run by Bonalive Biomaterials Ltd at 1 site in Finland.
Trial summary
A retrospective, single-tertiary centre observational study. The study population consists mainly of patients with instrumented posterolateral spine fusion operated at the Department of Neurosurgery or at the Department of Orthopaedics and Traumatology in the Turku University Hospital. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spine Fusion, Spinal Deformity
- What is being tested?
- S53P4 bioactive glass putty
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteFinland
- Study dates
- 3 May 2021to 31 Dec 2022
- How long will I take part?
- 2 Years
- 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
- Child, Adult, Older adult
Study population: The study population consists mainly of patients with instrumented posterolateral spine fusion operated at the Department of Neurosurgery or at the Department of Orthopaedics and Traumatology in the Turku University Hospital. Also, patients with non-instrumented posterolateral spine fusion, interbody spine fusion, and a combination of posterolateral and interbody spine fusion are included.
Who may be able to join
- Performed spine fusion operation
- BonAlive® putty used in the operation
Who cannot join
- Age under 18
- Use of other synthetic bone graft substitute or expander materials than BonAlive® putty in the operation
- Less time than two years since the index operation and no CT-proof of intended bony fusion
Trial locations and contacts
1 site in 1 country.
Finland1 site
Turku University Hospital Department of Neurosurgery
Turku, 207520
About this study
Official title: Clinical Safety and Efficacy of S53P4 Bioactive Glass Putty in Spinal Fusion Surgery: Post Market Clinical Follow-up Study
A retrospective, single-tertiary centre observational study.
The study population consists mainly of patients with instrumented posterolateral spine fusion operated at the Department of Neurosurgery or at the Department of Orthopaedics and Traumatology in the Turku University Hospital. Also, patients with non-instrumented posterolateral spine fusion, interbody spine fusion, and a combination of posterolateral and interbody spine fusion are included.
The approximate number of the above-mentioned operations with BonAlive® putty is 400 - 500 between September 2013 and April 2021. In the operations, the BonAlive® putty was used either alone, together with autologous bone (AB) chips, with milled allogenous bone chips, with demineralized bone matrix (DBM), with other synthetic bone grafts, or with a combination of the above-mentioned.
Read the detailed description
In the first stage of the investigation, the clinical safety and efficacy of BonAlive® putty are assessed in a retrospective case-series, and the observations are compared to the existing literature. Thereafter, a retrospective case-controlled study will be created to compare the use of a mixture of BonAlive® putty and AB to AB alone for clinical safety and efficacy. The cases will be matched up with the controls by gender, age, smoking behavior, the number of operated levels and the site of operated levels as far as possible. The chosen surgical technique will be the most commonly used.
- Conditions
- Spine Fusion, Spinal Deformity
- Being tested
- S53P4 bioactive glass putty
- Keywords
- S53P4, Bonalive, Bioactive glass putty, Spine fusion, Lumbar spine fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S53P4 bioactive glass puttyDevice
Also called Bonalive® putty, Bonalive® putty MIS
Bonalive putty/putty MIS paste is a synthetic, bioactive, osteoconductive, osteostimulative bone void filler for filling, reconstruction, and regeneration of bone defects.
| Study group | Role | What they receive |
|---|---|---|
| The use of a mixture of BonAlive® putty and autologous bone | A retrospective case-controlled study will be created to compare the use of a mixture of BonAlive® putty and autologous bone to autologous bone alone for clinical safety and efficacy. Receives: Device: S53P4 bioactive glass putty |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the clinical efficacy of BonAlive® (S53P4 bioactive glass) putty in spine fusion operations when used alone and together with autologous bone.
Radiologic endpoints are based on a neuroradiologist evaluatyion possible complications (breakage and/or loosening of the instrumentation) and bony fusion on a modified Bridwell grading criteria I-IV for PLF.
Measured: 24 months
Clinical outcomes are for pain VAS:
Visual analogue scale 1-10.
Measured: 24 months
EQ-5D cost effectiviness questionnaires.
Values are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation.
Measured: 24 months
ODI: (Oswestry Low Back Pain Disability Questionnaire).
ODI is validated to use in patients with low back pain.The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.
Measured: 24 months
15 D questionnaire The 15D is a generic, comprehensive (15-dimensional), self-administered instrument for measuring HRQoL among adults.
Health index on a 0-1 scale has been used successfully in several pharmacoeconomic evaluations. The maximum score is 1 (no problems on any dimension) and the minimum score is 0 (being dead).
Measured: 24 months
Secondary outcomes (2)
To demonstrate that the clinical efficacy of BonAlive® putty used together with autologous bone in spine fusion operations is not inferior to the clinical efficacy of autologous bone used alone.
Radiologic endpoints are based on a neuroradiologist evaluation possible complications; 1. breakage and/or loosening of the instrumentation 2. bony fusion on a modified Bridwell grading criteria for PLF.
Measured: 24 months
To demonstrate that the clinical use of BonAlive® putty does not cause excess infections or other complications subsequent to spine fusion operations compared to the reported amounts in the literature without the use of BonAlive® putty.
Odom´s scale
1 Excellent: No symptoms related to cervicaldisease.Able to perform daily activities without limitations. 2 Good: Moderate symptoms related tocervical disease.Able to perform daily activities without significant limitations. 3 Satisfactory: Slight improvement in symptomsrelated to cervical disease.Significant limitations in daily activities. 4 Poor: No improvement in, or aggravation of,symptoms related to cervical disease.Not able to perform daily activities.
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 posted12 Aug 2021
- Study start3 May 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine FusionStudies 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
- Case-control
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Bonalive Biomaterials Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Turku University Hospital
- Responsible party
- Sponsor
- Investigators
- Ilkka Saarenpää, MD, PhD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001893
- Sponsor's protocol ID
- 103-CL01
- Status last verified
- Jul 2021
- First submitted
- 4 May 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Safety and Efficacy of S53P4 Bioactive Glass Putty in Spinal Fusion Surgery: Post Market Clinical Follow-up Study
- ClinicalTrials.gov ID
- NCT05001893
- Acronym / sponsor ID
- 103-CL01
- Conditions
- Spine Fusion, Spinal Deformity
- Keywords
- S53P4, Bonalive, Bioactive glass putty, Spine fusion, Lumbar spine fusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Bonalive Biomaterials LtdIndustry (pharma, biotech, devices)
- Collaborators
- Turku University Hospital
- Study start
- 3 May 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 12 Aug 2021 (actual)
- 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.
A retrospective, single-tertiary centre observational study.
The study population consists mainly of patients with instrumented posterolateral spine fusion operated at the Department of Neurosurgery or at the Department of Orthopaedics and Traumatology in the Turku University Hospital. Also, patients with non-instrumented posterolateral spine fusion, interbody spine fusion, and a combination of posterolateral and interbody spine fusion are included.
The approximate number of the above-mentioned operations with BonAlive® putty is 400 - 500 between September 2013 and April 2021. In the operations, the BonAlive® putty was used either alone, together with autologous bone (AB) chips, with milled allogenous bone chips, with demineralized bone matrix (DBM), with other synthetic bone grafts, or with a combination of the above-mentioned.
Detailed description
In the first stage of the investigation, the clinical safety and efficacy of BonAlive® putty are assessed in a retrospective case-series, and the observations are compared to the existing literature. Thereafter, a retrospective case-controlled study will be created to compare the use of a mixture of BonAlive® putty and AB to AB alone for clinical safety and efficacy. The cases will be matched up with the controls by gender, age, smoking behavior, the number of operated levels and the site of operated levels as far as possible. The chosen surgical technique will be the most commonly used.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The use of a mixture of BonAlive® putty and autologous bone | – | Device: S53P4 bioactive glass puttyA retrospective case-controlled study will be created to compare the use of a mixture of BonAlive® putty and autologous bone to autologous bone alone for clinical safety and efficacy. |
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists mainly of patients with instrumented posterolateral spine fusion operated at the Department of Neurosurgery or at the Department of Orthopaedics and Traumatology in the Turku University Hospital. Also, patients with non-instrumented posterolateral spine fusion, interbody spine fusion, and a combination of posterolateral and interbody spine fusion are included.
Key inclusion criteria (2 listed)
- Performed spine fusion operation
- BonAlive® putty used in the operation
Key exclusion criteria (3 listed)
- Age under 18
- Use of other synthetic bone graft substitute or expander materials than BonAlive® putty in the operation
- Less time than two years since the index operation and no CT-proof of intended bony fusion
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 |
|---|---|---|
| S53P4 bioactive glass puttyAlso: Bonalive® putty, Bonalive® putty MISBonalive putty/putty MIS paste is a synthetic, bioactive, osteoconductive, osteostimulative bone void filler for filling, reconstruction, and regeneration of bone defects. | Device | The use of a mixture of BonAlive® putty and autologous bone |
Primary outcome
To demonstrate the clinical efficacy of BonAlive® (S53P4 bioactive glass) putty in spine fusion operations when used alone and together with autologous bone.
Time frame: 24 months
Radiologic endpoints are based on a neuroradiologist evaluatyion possible complications (breakage and/or loosening of the instrumentation) and bony fusion on a modified Bridwell grading criteria I-IV for PLF.
Clinical outcomes are for pain VAS:
Time frame: 24 months
Visual analogue scale 1-10.
EQ-5D cost effectiviness questionnaires.
Time frame: 24 months
Values are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation.
ODI: (Oswestry Low Back Pain Disability Questionnaire).
Time frame: 24 months
ODI is validated to use in patients with low back pain.The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.
15 D questionnaire The 15D is a generic, comprehensive (15-dimensional), self-administered instrument for measuring HRQoL among adults.
Time frame: 24 months
Health index on a 0-1 scale has been used successfully in several pharmacoeconomic evaluations. The maximum score is 1 (no problems on any dimension) and the minimum score is 0 (being dead).
2 secondary outcomes
To demonstrate that the clinical efficacy of BonAlive® putty used together with autologous bone in spine fusion operations is not inferior to the clinical efficacy of autologous bone used alone.
Time frame: 24 months
To demonstrate that the clinical use of BonAlive® putty does not cause excess infections or other complications subsequent to spine fusion operations compared to the reported amounts in the literature without the use of BonAlive® putty.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- 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.
Ilkka Saarenpää, MD, PhD principal investigator
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spine Fusion and Spinal Deformity, run by Bonalive Biomaterials Ltd at 1 site in Finland.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. 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?
Results are not available in the source record.
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?
To demonstrate the clinical efficacy of BonAlive® (S53P4 bioactive glass) putty in spine fusion operations when used alone and together with autologous bone. (time frame: 24 months). The study lists 5 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 12 Aug 2021.