NCT02250248

Brief Summary

The objective of this study is to evaluate the clinical success of AttraX Putty as a bone graft substitute for autograft in XLIF procedures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 26, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2021

Completed
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

6.5 years

First QC Date

September 23, 2014

Last Update Submit

December 16, 2025

Conditions

Degenerative Conditions of the Lumbar Spine

Keywords

Degenerative disc diseaseLumbar spine

Outcome Measures

Primary Outcomes (1)

  • The number and percentage of subjects with radiographically apparent fusion 24 months.

    The number and percentage of subjects with radiographically apparent fusion 24 months.

    24-months

Secondary Outcomes (3)

  • The rate of complications attributable to the use of AttraX and ICBG autograft.

    Post-op to 24-months

  • The change in self-reported clinical outcomes scores from baseline through 24 month follow-up, including VAS (back, leg, and iliac crest pain), ODI, EQ5D, and SF-36.

    Pre-op through 24-months

  • The morbidity associated graft harvest as measured by operative time, blood loss, length of hospital stay, postoperative pain, and infection rate.

    Surgery through 24-months

Study Arms (2)

AttraX Putty

ACTIVE COMPARATOR

Patient will be treated with AttraX Putty intraoperatively.

Biological: AttraX Putty

Iliac Crest Bone Graft (ICBG)

ACTIVE COMPARATOR

Patients will be treated with ICBG harvested during surgery.

Other: Iliac Crest Bone Graft (ICBG)

Interventions

AttraX PuttyBIOLOGICAL
AttraX Putty
Iliac Crest Bone Graft (ICBG)OTHER
Also known as: autograft
Iliac Crest Bone Graft (ICBG)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persistent back and/or leg pain unresponsive to conservative treatment for at least 6 months, unless surgical treatment is clinically indicated sooner
  • Indicated for a single-level XLIF between L1 and L5 with bilateral percutaneous pedicle screws
  • Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies
  • years of age at the date of written informed consent
  • Able to undergo surgery based on physical exam, medical history, and surgeon judgment
  • Expected to survive at least 2 years beyond surgery
  • Willing and able to return for post-treatment exams according to the follow-up called for in the protocol
  • Signed and dated informed consent form

You may not qualify if:

  • Mental or physical condition that would limit the ability to comply with study requirements
  • Spine abnormality requiring treatment at more than one level
  • Previous failed fusion at any spinal level
  • Prior fusion procedure at operative level (i.e., no revision of operative level)
  • Systemic or local infection; active or latent
  • Diseases that significantly inhibit bone healing (e.g., prior diagnosis of osteoporosis, metabolic bone disease)
  • Treatment with pharmaceuticals interfering with calcium metabolism
  • Undergoing chemotherapy or radiation treatment
  • Chronic use of steroids (defined as more than 6 weeks of steroid use within 12 months of surgery, other than episodic use or inhaled corticosteroids)
  • Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
  • Significant general illness (e.g., HIV, active metastatic cancer of any type, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease)
  • Immunocompromised or is being treated with immunosuppressive agents
  • Pregnant, or plans to become pregnant during the study
  • Subject is a prisoner
  • Participating in another clinical study that would confound study data
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mater Dei Hospital

Barro Prêto, Minas Gerais, 30140-093, Brazil

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Interventions

Transplantation, Autologous

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Study Officials

  • Cristiano M Menezes, M.D.

    Lifecenter to Mater Dei Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2014

First Posted

September 26, 2014

Study Start

December 1, 2014

Primary Completion

May 21, 2021

Study Completion

May 21, 2021

Last Updated

December 22, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)