NCT07667348尚未招募4 期
Return to Activity After Surgery for Lumbar Disc Herniation: An Exploratory, Post-Market, Prospective, Randomized, Controlled Trial of an Annular Closure Device
Intrinsic Therapeutics1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年6月30日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
研究概览
简要总结
RCT investigating postoperative activity restriction after lumbar discectomy in patients treated with annular closure.
详细描述
The purpose of this prospective, randomized, multicenter study is to determine the reherniation and reoperation rates of patients treated with the annular closure device after standard post-operative restrictions versus patient-determined restrictions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletally mature (male or female).
- •Patients with posterior or posterolateral disc herniations at one level between L4 and S1 with radiographic confirmation of neural compression using MRI. [Note: Intraoperatively, only patients with an annular defect (post discectomy) between 4mm and 6mm tall and 6mm and 10mm wide shall qualify.]
- •Minimum posterior disc height of 5mm at the index level.
- •Radiculopathy (with or without back pain) with a positive Straight Leg Raise (0 - 60 degrees)22 (L45, L5S1)
- •VAS leg pain (one or both legs) of at least 40/100 at baseline
- •Psychosocially, mentally and physically able to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.
- •Implanted with annular closure device.
排除标准
- •Spondylolisthesis Grade II or higher (25% slip or greater).
- •Subject requires spinal surgery other than a discectomy (with or without laminotomy) to treat leg/back pain (scar tissue and osteophyte removal is allowed).
- •Subject has been diagnosed with active hepatitis, AIDS, or HIV.
- •Subject has been diagnosed with rheumatoid arthritis or other autoimmune disease.
- •Subject has a known allergy to titanium, polyethylene or polyester materials.
- •Any subject that cannot have a baseline MRI taken.
- •Subject is pregnant or interested in becoming pregnant in the next year.
- •Subject has active tuberculosis or has had tuberculosis in the past three (3) years.
- •Subject has a history of active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no signs or symptoms of the malignancy for at least two (2) years.
- •Subject is immunologically suppressed, received steroids >1 month over the past year.
- •Currently taking anticoagulants, other than aspirin, unless the patient can be taken off the anticoagulant for surgery.
- •Subject has a current chemical/alcohol dependency or significant psychosocial disturbance.
- •Subject has a life expectancy of less than three (3) years.
- •Subject is currently involved in active spinal litigation (Workers' compensation patients may be included.
- •Subject is currently involved in another investigational study.
- •Subject is incarcerated.
- •Subject has back or non-radicular leg pain of unknown etiology.
- •Prior surgery at the index lumbar vertebral level.
- •Subject requiring a spine DEXA (i.e., patients with SCORE of ≥ 6) with a T Score less than -2.0 at the index level. For patients with a herniation at L5/S1, the average T score of L1-L4 shall be used.
- •Subject has clinically compromised vertebral bodies in the lumbosacral region due to any traumatic, neoplastic, metabolic, or infectious pathology.
- •Subject has sustained pathologic fractures of the vertebra or multiple fractures of the vertebra or hip.
- •Subject has scoliosis of greater than ten (10) degrees (both angular and rotational).
- •Any metabolic bone disease.
- •Subject has an active infection either systemic or local.
- •Subject has cauda equina syndrome or neurogenic bowel/bladder dysfunction.
- •Subject has severe arterial insufficiency of the legs or other peripheral vascular disease. (Screening on physical examination for patients with diminution or absence of dorsalis pedis or posterior tibialis pulses. If diminished or absent by palpation, then an arterial ultrasound is required with vascular plethysmography. If the absolute arterial pressure is below 50mm of Hg at the calf or ankle level, then the patient is to be excluded.)
- •Subject has significant peripheral neuropathy, patient defined as a patient with Type I or Type II diabetes or similar systemic metabolic condition causing decreased sensation in a stocking-like or non-radicular and non-dermatomal distribution in the lower extremities.
- •Subject has insulin-dependent diabetes mellitus.
- •Subject is morbidly obese (defined as a body mass index >40 or weighs more than 100 lbs. over ideal body weight).
研究者
研究点 (1)
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