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RCT of AttraX® Putty vs. Autograft in Instrumented Posterolateral Spinal Fusion (AxA)

Primary Purpose

Spinal Deformity, Spinal Instability, Instrumented Spinal Fusion

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
AttraX® Putty
Autologous bone graft
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Deformity focused on measuring Bone graft, Ceramic, Spinal fusion, RCT, Thoracolumbar region

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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;
  • 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.

Sites / Locations

  • Onze Lieve Vrouwe Gasthuis
  • Rijnstate Hospital
  • Amphia Hospital
  • University Medical Center Utrecht

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AttraX condition

Autograft condition

Arm Description

8-10cc of AttraX® Putty per spinal level at the randomized allocation side of the spine (left or right).

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
October 28, 2013
Last Updated
February 4, 2019
Sponsor
UMC Utrecht
Collaborators
NuVasive
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1. Study Identification

Unique Protocol Identification Number
NCT01982045
Brief Title
RCT of AttraX® Putty vs. Autograft in Instrumented Posterolateral Spinal Fusion
Acronym
AxA
Official Title
A Randomized Controlled Trial of AttraX® Putty vs. Autograft in Instrumented Posterolateral Spinal Fusion
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht
Collaborators
NuVasive

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Deformity, Spinal Instability, Instrumented Spinal Fusion
Keywords
Bone graft, Ceramic, Spinal fusion, RCT, Thoracolumbar region

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AttraX condition
Arm Type
Experimental
Arm Description
8-10cc of AttraX® Putty per spinal level at the randomized allocation side of the spine (left or right).
Arm Title
Autograft condition
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
AttraX® Putty
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Autologous bone graft
Intervention Description
Corticocancellous bone harvested from the iliac crest, with our without local bone obtained from decompression and/or preparation for fusion (facetectomy and denudement).
Primary Outcome Measure Information:
Title
Posterior spinal fusion rate after one year
Description
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.
Time Frame
One year (12-15 months) after surgery
Title
Rate of (serious) adverse events with a potential relation with AttraX® Putty
Description
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.
Time Frame
Untill 2 years (24-27 months) after surgery
Secondary Outcome Measure Information:
Title
Resorption characteristics of AttraX® Putty compared to autograft during the first year
Description
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.
Time Frame
During the first year (12-15 months) after surgery
Title
Volume of bridging bone mass after one year
Description
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.
Time Frame
One year (12-15 months) after surgery
Title
Visual analogue pain scale of iliac crest pain
Description
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.
Time Frame
During two years (24-27 months) after surgery
Title
Correlation of posterior fusion rate to the presence of interbody fusion after one year
Description
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.
Time Frame
One year (12-15 months) after surgery
Title
Posterior spinal fusion rate after two years
Description
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.
Time Frame
Two years (24-27 months) after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Exclusion Criteria: 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; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moyo Kruyt, MD, PhD
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
ZIP/Postal Code
1091 AC
Country
Netherlands
Facility Name
Rijnstate Hospital
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
Facility Name
Amphia Hospital
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
University Medical Center Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
35297288
Citation
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.
Results Reference
derived

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RCT of AttraX® Putty vs. Autograft in Instrumented Posterolateral Spinal Fusion

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