- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02250248
AttraX® Putty vs. Autograft in XLIF®
August 20, 2021 updated by: NuVasive
AttraX® Putty vs. Autograft in eXtreme Lateral Interbody Fusion (XLIF®): A Prospective Randomized Single-Center Evaluation of Radiographic and Clinical Outcomes
The objective of this study is to evaluate the clinical success of AttraX Putty as a bone graft substitute for autograft in XLIF procedures.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a single-center, prospective, randomized study.
Subjects will be recruited from patients already under the Investigator's care who are indicated for XLIF with iliac crest bone graft (ICBG) autograft or AttraX Putty.
To minimize bias, all consecutive patients at a given investigational site who meet eligibility requirements will be asked to consent to participate in the study whereby the biologic (ICBG autograft or AttraX Putty) will be randomly assigned.
All subjects will be followed for 24 months following surgery to quantify the clinical and radiographic improvements of each biologic compared to baseline and in comparison with each other.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minas Gerais
-
Barro Preto, Minas Gerais, Brazil, 30140-093
- Mater Dei Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 18-80 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
Exclusion Criteria:
- 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)
- Prior adjacent level fusion (note: prior decompression is not an exclusion)
- 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
- At risk to be non-compliant (e.g. (recently treated for) substance abuse, detainee, likely to immigrate)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: AttraX Putty
Patient will be treated with AttraX Putty intraoperatively.
|
|
Active Comparator: Iliac Crest Bone Graft (ICBG)
Patients will be treated with ICBG harvested during surgery.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number and percentage of subjects with radiographically apparent fusion 24 months.
Time Frame: 24-months
|
The number and percentage of subjects with radiographically apparent fusion 24 months.
|
24-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The rate of complications attributable to the use of AttraX and ICBG autograft.
Time Frame: Post-op to 24-months
|
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.
Time Frame: Pre-op through 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.
Time Frame: Surgery 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cristiano M Menezes, M.D., Lifecenter to Mater Dei Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2014
Primary Completion (Actual)
May 21, 2021
Study Completion (Actual)
May 21, 2021
Study Registration Dates
First Submitted
September 23, 2014
First Submitted That Met QC Criteria
September 23, 2014
First Posted (Estimate)
September 26, 2014
Study Record Updates
Last Update Posted (Actual)
August 24, 2021
Last Update Submitted That Met QC Criteria
August 20, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NUVA.AX1401
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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