AttraX® Putty vs. Autograft in eXtreme Lateral Interbody Fusion (XLIF®): A Prospective Randomized Single-Center Evaluation of Radiographic and Clinical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- The number and percentage of subjects with radiographically apparent fusion 24 months.
研究概览
简要总结
The objective of this study is to evaluate the clinical success of AttraX Putty as a bone graft substitute for autograft in XLIF procedures.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
AttraX Putty
Patient will be treated with AttraX Putty intraoperatively.
干预措施: AttraX Putty (Biological)
Iliac Crest Bone Graft (ICBG)
Patients will be treated with ICBG harvested during surgery.
干预措施: Iliac Crest Bone Graft (ICBG) (Other)
结局指标
主要结局
The number and percentage of subjects with radiographically apparent fusion 24 months.
时间窗: 24-months
The number and percentage of subjects with radiographically apparent fusion 24 months.
次要结局
- 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)