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

NCT01982045 | Completed

• 1 other identifier: NL44095.041.13
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

Spinal Deformity; Spinal Instability; Instrumented Spinal Fusion

Keywords

Bone graft; Ceramic; Spinal fusion; RCT; Thoracolumbar region

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Resorption characteristics of AttraX® Putty compared to autograft during the first year

  During the first year (12-15 months) after surgery

• Volume of bridging bone mass after one year

  One year (12-15 months) after surgery

• Visual analogue pain scale of iliac crest pain

  During two years (24-27 months) after surgery

• Correlation of posterior fusion rate to the presence of interbody fusion after one year

  One year (12-15 months) after surgery

• Posterior spinal fusion rate after two years

  Two years (24-27 months) after surgery

Study Arms (2)

AttraX condition

EXPERIMENTAL

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

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.

Other: Autologous bone graft

Interventions

AttraX® Putty DEVICE

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.

AttraX condition

Autologous bone graft OTHER

Corticocancellous bone harvested from the iliac crest, with our without local bone obtained from decompression and/or preparation for fusion (facetectomy and denudement).

Autograft condition

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• UMC Utrecht: lead
• NuVasive: collaborator

Study Sites (4)

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 AC, Netherlands

Location

Rijnstate Hospital

Arnhem, 6815 AD, Netherlands

Location

Amphia Hospital

Breda, 4818 CK, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 35297288 DERIVED

Study Officials

• Moyo Kruyt, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic surgeon

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: November 13, 2013
• Study Start: October 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: August 1, 2018
• Last Updated: February 5, 2019

Record last verified: 2019-02

Locations

NL (4)