Spinal Deformity Clinical Trial
— AxAOfficial title:
A Randomized Controlled Trial of AttraX® Putty vs. Autograft in Instrumented Posterolateral Spinal Fusion
NCT number | NCT01982045 |
Other study ID # | NL44095.041.13 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2013 |
Est. completion date | August 2018 |
Verified date | February 2019 |
Source | UMC Utrecht |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | August 2018 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Onze Lieve Vrouwe Gasthuis | Amsterdam | |
Netherlands | Rijnstate Hospital | Arnhem | |
Netherlands | Amphia Hospital | Breda | |
Netherlands | University Medical Center Utrecht | Utrecht |
Lead Sponsor | Collaborator |
---|---|
UMC Utrecht | NuVasive |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | One year (12-15 months) after surgery | |
Primary | 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. | Untill 2 years (24-27 months) after surgery | |
Secondary | 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. | During the first year (12-15 months) after surgery | |
Secondary | 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. | One year (12-15 months) after surgery | |
Secondary | 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. | During two years (24-27 months) after surgery | |
Secondary | 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. | One year (12-15 months) after surgery | |
Secondary | 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. | Two years (24-27 months) after surgery |
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