Spinal DeformityAxANCT01982045
RCT of AttraX® Putty vs. Autograft in Instrumented Posterolateral Spinal Fusion
A study testing AttraX® Putty and Autologous bone graft in people with Spinal Deformity and Spinal Instability, run by UMC Utrecht at 4 sites in Netherlands.
Trial summary
The purpose of this study is to demonstrate the non-inferiority of AttraX® Putty as a bone graft substitute for autograft in instrumented posterolateral fusion of the thoracolumbar spine, in terms of efficacy and safety. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Deformity, Spinal Instability, Instrumented Spinal Fusion
- What is being tested?
- AttraX® Putty and Autologous bone graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesNetherlands
- Study dates
- Oct 2013to Aug 2018
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be treated with instrumented posterolateral thoracolumbar spinal fusion, with or without additional posteriorly inserted interbody devices (PLIF, TLIF), because of (1) deformity, (2) structural instability and/or (3) expected instability as a result of decompression for spinal stenosis;
- Non-responsive to at least 6 months of non-operative treatment prior to study enrollment;
- Fusion indicated for one or more levels in the T10 to S1/ilium region;
- Willing and able to understand and sign the study specific Patient Informed Consent;
- Skeletally mature between 18 and 80 years of age;
Who cannot join
- Any previous surgical attempt(s) for spinal fusion (revision surgery);
- Previous treatments that compromise fusion surgery like irradiation;
- Previous autologous bone grafting procedures that compromise the quality and amount of iliac crest bone grafting;
- Indication for spinal fusion because of a traumatic reason, like a spinal fracture or traumatic instability;
- Active spinal and/or systemic infection;
- Spinal metastasis in the area intended for fusion;
Show all 13Show fewer
- Systemic disease or condition, which would affect the subjects ability to participate in the study requirements or the ability to evaluate the efficacy of the graft (e.g. active malignancy, neuropathy);
- At risk to be non-compliant (e.g. (recently treated for) substance abuse, detainee, likely to immigrate);
- Participation in clinical trials evaluating investigational devices, pharmaceuticals or biologics within 3 months of enrollment in the study;
- Female patients who intend to be pregnant within 1.5 year of enrollment in the study;
- Body mass index (BMI) larger than 35 (morbidly obese);
- Being expected to require additional surgery to the same spinal region within the next 6 months;
- Current or recent (<1yr) corticosteroid use equivalent to prednisone ≥5mg/day, prescribed for more than 6 weeks.
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Onze Lieve Vrouwe Gasthuis
Amsterdam, 1091 AC
Rijnstate Hospital
Arnhem, 6815 AD
Amphia Hospital
Breda, 4818 CK
University Medical Center Utrecht
Utrecht, 3584 CX
About this study
Official title: A Randomized Controlled Trial of AttraX® Putty vs. Autograft in Instrumented Posterolateral Spinal Fusion
The purpose of this study is to demonstrate the non-inferiority of AttraX® Putty as a bone graft substitute for autograft in instrumented posterolateral fusion of the thoracolumbar spine, in terms of efficacy and safety.
Read the detailed description
Spinal fusion, a surgical procedure frequently used for many spinal conditions requiring stabilization of the vertebral column, is currently performed by using large amounts of autologous bone graft or autograft. A substitute for this patient own bone would eliminate the graft harvesting morbidity that is currently one of the main disadvantages. Recently, a promising synthetic graft substitute has been developed that has shown favorable results in pre-clinical studies. This product is AttraX® Putty (CE-557130), a bioresorbable tricalcium phosphate (TCP), mixed with a fast resorbing polymer carrier to improve surgical handling. The aim of the current study is to clinically investigate AttraX® Putty as an alternative to autologous bone graft in adult patients qualified for instrumented posterolateral fusion of the thoracolumbar spine (T10-S1).
The study design is a patient and observer blinded, controlled, randomized, multi-center clinical trial with intra-patient comparisons. This means that each patient is it owns control. According to a randomization scheme, one side of the spine will be grafted with AttraX® Putty the other side receives bone harvest from the iliac crest, which is currently the gold standard.
The primary outcomes of this study are the posterior spinal fusion rate after one year (based on CT-scans), and potential serious adverse events related with AttraX® Putty. Secondary outcomes are the resorption characteristics during the first year, volume of bridging bone mass after one year, evaluation of iliac crest pain, correlation of the posterior fusion rate to the presence of interbody fusion after one year and the posterior spinal fusion rate after two years.
- Being tested
- AttraX® Putty, Autologous bone graft
- Keywords
- Bone graft, Ceramic, Spinal fusion, RCT, Thoracolumbar region
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AttraX® PuttyDevice
Synthetic bone graft comprised of calcium phosphate granules and hydroxyapatite with an advanced biodissolvable polymer carrier that allows for better handling of the granules in putty form.
Autologous bone graftOther
Corticocancellous bone harvested from the iliac crest, with our without local bone obtained from decompression and/or preparation for fusion (facetectomy and denudement).
| Study group | Role | What they receive |
|---|---|---|
| AttraX condition | Experimental | 8-10cc of AttraX® Putty per spinal level at the randomized allocation side of the spine (left or right). Receives: Device: AttraX® Putty |
| Autograft condition | Active comparator | 8-10cc autologous bone graft per spinal level at the control side of the spine. This can be a combination of local bone and iliac crest bone, but at least 50% of the volume has to be iliac crest bone graft. Receives: Other: Autologous bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posterior spinal fusion rate after one year
For the efficacy analysis of AttraX® Putty as a bone graft substitute for autograft in instrumented posterolateral fusion of the thoracolumbar spine, a comparison will be made between the fusion performance of the AttraX condition and the autograft condition after one year, assessed at CT-scans. Non-inferiority of AttraX® Putty will be tested with a McNemar's test.
Measured: One year (12-15 months) after surgery
Rate of (serious) adverse events with a potential relation with AttraX® Putty
The safety of AttraX® Putty will be evaluated by documenting the number and nature of all (serious) adverse events that occur within the study population. The complication rate will be compared to the rate in control populations from the UMC Utrecht and a recently performed comparable multicenter-RCT coordinated by the UMC Utrecht. In addition, all (serious) adverse events will be evaluated for any potential relation with AttraX® Putty.
Measured: Untill 2 years (24-27 months) after surgery
Secondary outcomes (5)
Resorption characteristics of AttraX® Putty compared to autograft during the first year
In a subset of the study population, additional DEXA-scans at 1-5 days after surgery (reference scan) and at 6 weeks, 3 months, 6 months and 1 year follow-up will be made to evaluate the resorption characteristics of AttraX® Putty compared to autograft in the instrumented fusion locations.
Measured: During the first year (12-15 months) after surgery
Volume of bridging bone mass after one year
As quantification of the bone mass volume allows more detailed investigation of the amount of bone that has been formed, the volume of bridging bone mass derived from AttraX® Putty will be compared with the bone mass derived from autograft, using the one year CT scans made for the primary objective.
Measured: One year (12-15 months) after surgery
Visual analogue pain scale of iliac crest pain
Assessments of iliac crest pain at 6 weeks, 3 months, 6 months, 1 year and 2 years follow-up, by patients blinded to the side of graft harvesting from the iliac crest, will be analysed to investigate the relevance of donor site pain.
Measured: During two years (24-27 months) after surgery
Correlation of posterior fusion rate to the presence of interbody fusion after one year
The correlation of the posterior fusion rate to the presence of interbody fusion will be assessed at the one year CT scans made for the primary objective.
Measured: One year (12-15 months) after surgery
Posterior spinal fusion rate after two years
To determine the long-term fusion potential and behavior from AttraX® Putty and autograft, a comparison will be made between the fusion performance of both conditions after two years, assessed at CT-scans. Only those patients that scored a doubtful fusion or non-union in any of the relevant levels at the one-year CT scan will be scanned.
Measured: Two years (24-27 months) after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2017
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal DeformityStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- NuVasive
- Responsible party
- Principal investigator, M.C. Kruyt, MD, PhD, UMC Utrecht
- Investigators
- Moyo Kruyt, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982045
- Sponsor's protocol ID
- NL44095.041.13
- Acronym
- AxA
- Status last verified
- Feb 2019
- First submitted
- 28 Oct 2013
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Lehr AM, Jacobs WC, Stellato RK, Castelein RM, Cumhur Oner F, Kruyt MC. Methodological aspects of a randomized within-patient concurrent controlled design for clinical trials in spine surgery. Clin Trials. 2022 Jun;19(3):259-266. doi: 10.1177/17407745221084705. Epub 2022 Mar 17.
PubMed 35297288
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of AttraX® Putty vs. Autograft in Instrumented Posterolateral Spinal Fusion
- ClinicalTrials.gov ID
- NCT01982045
- Acronym / sponsor ID
- AxA / NL44095.041.13
- Keywords
- Bone graft, Ceramic, Spinal fusion, RCT, Thoracolumbar region
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- NuVasive
- Study start
- Oct 2013 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 13 Nov 2013 (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 study is to demonstrate the non-inferiority of AttraX® Putty as a bone graft substitute for autograft in instrumented posterolateral fusion of the thoracolumbar spine, in terms of efficacy and safety.
Detailed description
Spinal fusion, a surgical procedure frequently used for many spinal conditions requiring stabilization of the vertebral column, is currently performed by using large amounts of autologous bone graft or autograft. A substitute for this patient own bone would eliminate the graft harvesting morbidity that is currently one of the main disadvantages. Recently, a promising synthetic graft substitute has been developed that has shown favorable results in pre-clinical studies. This product is AttraX® Putty (CE-557130), a bioresorbable tricalcium phosphate (TCP), mixed with a fast resorbing polymer carrier to improve surgical handling. The aim of the current study is to clinically investigate AttraX® Putty as an alternative to autologous bone graft in adult patients qualified for instrumented posterolateral fusion of the thoracolumbar spine (T10-S1).
The study design is a patient and observer blinded, controlled, randomized, multi-center clinical trial with intra-patient comparisons. This means that each patient is it owns control. According to a randomization scheme, one side of the spine will be grafted with AttraX® Putty the other side receives bone harvest from the iliac crest, which is currently the gold standard.
The primary outcomes of this study are the posterior spinal fusion rate after one year (based on CT-scans), and potential serious adverse events related with AttraX® Putty. Secondary outcomes are the resorption characteristics during the first year, volume of bridging bone mass after one year, evaluation of iliac crest pain, correlation of the posterior fusion rate to the presence of interbody fusion after one year and the posterior spinal fusion rate after two years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AttraX condition | Experimental | Device: AttraX® Putty8-10cc of AttraX® Putty per spinal level at the randomized allocation side of the spine (left or right). |
| Autograft condition | Active comparator | Other: Autologous bone graft8-10cc autologous bone graft per spinal level at the control side of the spine. This can be a combination of local bone and iliac crest bone, but at least 50% of the volume has to be iliac crest bone graft. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- To be treated with instrumented posterolateral thoracolumbar spinal fusion, with or without additional posteriorly inserted interbody devices (PLIF, TLIF), because of (1) deformity, (2) structural instability and/or (3) expected instability as a result of decompression for spinal stenosis;
- Non-responsive to at least 6 months of non-operative treatment prior to study enrollment;
- Fusion indicated for one or more levels in the T10 to S1/ilium region;
- Willing and able to understand and sign the study specific Patient Informed Consent;
- Skeletally mature between 18 and 80 years of age;
Key exclusion criteria (13 listed)
- Any previous surgical attempt(s) for spinal fusion (revision surgery);
- Previous treatments that compromise fusion surgery like irradiation;
- Previous autologous bone grafting procedures that compromise the quality and amount of iliac crest bone grafting;
- Indication for spinal fusion because of a traumatic reason, like a spinal fracture or traumatic instability;
- Active spinal and/or systemic infection;
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 |
|---|---|---|
| AttraX® PuttySynthetic bone graft comprised of calcium phosphate granules and hydroxyapatite with an advanced biodissolvable polymer carrier that allows for better handling of the granules in putty form. | Device | AttraX condition |
| Autologous bone graftCorticocancellous bone harvested from the iliac crest, with our without local bone obtained from decompression and/or preparation for fusion (facetectomy and denudement). | Other | Autograft condition |
Primary outcome
Posterior spinal fusion rate after one year
Time frame: One year (12-15 months) after surgery
For the efficacy analysis of AttraX® Putty as a bone graft substitute for autograft in instrumented posterolateral fusion of the thoracolumbar spine, a comparison will be made between the fusion performance of the AttraX condition and the autograft condition after one year, assessed at CT-scans. Non-inferiority of AttraX® Putty will be tested with a McNemar's test.
Rate of (serious) adverse events with a potential relation with AttraX® Putty
Time frame: Untill 2 years (24-27 months) after surgery
The safety of AttraX® Putty will be evaluated by documenting the number and nature of all (serious) adverse events that occur within the study population. The complication rate will be compared to the rate in control populations from the UMC Utrecht and a recently performed comparable multicenter-RCT coordinated by the UMC Utrecht. In addition, all (serious) adverse events will be evaluated for any potential relation with AttraX® Putty.
5 secondary outcomes
Resorption characteristics of AttraX® Putty compared to autograft during the first year
Time frame: During the first year (12-15 months) after surgery
Volume of bridging bone mass after one year
Time frame: One year (12-15 months) after surgery
Visual analogue pain scale of iliac crest pain
Time frame: During two years (24-27 months) after surgery
Correlation of posterior fusion rate to the presence of interbody fusion after one year
Time frame: One year (12-15 months) after surgery
Posterior spinal fusion rate after two years
Time frame: Two years (24-27 months) after surgery
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 5 Feb 2019.
- Derived from this study: PubMed 35297288Lehr AM, Jacobs WC, Stellato RK, Castelein RM, Cumhur Oner F, Kruyt MC. Methodological aspects of a randomized within-patient concurrent controlled design for clinical trials in spine surgery. Clin Trials. 2022 Jun;19(3):259-266. doi: 10.1177/17407745221084705. Epub 2022 Mar 17.
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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.
Moyo Kruyt, MD, PhD principal investigator
UMC Utrecht
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AttraX® Putty and Autologous bone graft in people with Spinal Deformity and Spinal Instability, run by UMC Utrecht at 4 sites in Netherlands.
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 13 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 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. 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?
Posterior spinal fusion rate after one year (time frame: One year (12-15 months) after surgery). 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?
On the ClinicalTrials.gov record for NCT01982045, which also lists 1 linked publication.
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 5 Feb 2019.