NCT01982045

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

A Randomized Controlled Trial of AttraX® Putty vs. Autograft in Instrumented Posterolateral Spinal Fusion

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Deformity
• Spinal Instability
• Instrumented Spinal Fusion

Interventions

Type	Name	Description
DEVICE	AttraX® Putty	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.
OTHER	Autologous bone graft	Corticocancellous bone harvested from the iliac crest, with our without local bone obtained from decompression and/or preparation for fusion (facetectomy and denudement).

Timeline

• Start date: 2013-10-01
• Primary completion: 2017-07-01
• Completion: 2018-08-01
• First posted: 2013-11-13
• Last updated: 2019-02-05

Locations

4 sites across 1 country: Netherlands