NL-OMON38288尚未招募不适用
A Prospective, Randomized, Double-Blind, Multicenter Clinical Trial to Evaluate the Safety and Efficacy of the Z-Lig Medical Device Compared to Allograft for the Reconstruction of Ruptured Anterior Cruciate Ligaments - Z-Lig study
Aperion Biologics Inc.0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Potential Subject is able to provide informed consent and must sign the EC-approved Informed Consent Form,
- •2. Male or female between the ages of 18-60 years,
- •3. Skeletally mature as evidenced by closure of the epiphyseal plate on x-ray,
- •4. Simple ACL insufficiency with no concurrent multi-axial or multi-ligament instabilities or knee dislocations,
- •5. Diagnosed with an acute or chronic primary ruptured anterior cruciate ligament of the knee documented by:
- •a) physical exam with positive Lachman*s test or,
- •b) *5 mm side-to-side difference by KT 1000 (or 2000), 10-20 lb force or,
- •c) MRI of the affected knee
- •6. Acute injuries must not exhibit effusion or inflammation,,
- •7. Pre-Injury Tegner Activity Score <8,
- •8. If female, for the first 12 months post operative, actively practicing a contraception method, or practicing abstinence, or surgically sterilized, or postmenopausal,
- •Applicable to Denmark only:
- •9(a): Fertile women those are not pregnant as demonstrated by a negative pregnancy test at the baseline and prior to surgery and use safe method of contraception. Acceptable contraception methods include: intrauterine devices and hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices, injections with prolonged release).;9(b): Sterilized or infertile Subjects are exempt from the requirement to use contraception. Subjects must have undergone surgical sterilization (hysterectomy or bilateral ovariectomy) or be postmenopausal defined as 12 months or more with no menses prior to enrollment).
- •9. The contralateral knee is asymptomatic, stable and fully functional,
- •10. Must be physically and mentally willing and able to comply with post-operative rehabilitation and routinely scheduled clinical, radiographic and rehabilitation follow up visits through 24 months,
- •11. Osteoarthritis of Grade II-III acceptable based on the ICRS scale (no Grade IV prior to baseline) if the treatment does not impact the ACL rehabilitation protocol
- •12. Subjects requiring a meniscal repair without modification to the rehabilitation protocol.
排除标准
- •1. Pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding,
- •2. Has osteoarthritis of Grade IV,
- •3. Require a menisectomy (>50%) or meniscal repairs where the treatment has an impact the ACL rehabilitation protocol,
- •4. Has inflammatory arthritis determined by history, examination or serology,
- •5. Has an active or latent infection of the affected knee joint or any other systemic infection currently under treatment or treated with antibiotics within the previous 3 months,
- •6. Has a history of alcoholism, medication, or intravenous drug abuse, psychosis, has a personality disorder(s), poor motivation, emotional or intellectual issues that would likely make the potential Subject unreliable for the Trial, or any combination of variables in the Principal Investigator*s judgment that would exclude a potential Subject,
- •7. Clinically documented acute or chronic disease, other than the indication to be treated in this Trial that might affect life expectancy, or make it difficult to interpret the potential Subject*s outcome according to the Protocol (i.e., renal, hepatic, cardiac, endocrine, hematologic, autoimmune, metabolic bone, crystal deposition, severe degenerative joint, neoplastic diseases),
- •8. Potential Subjects with a medical condition that interferes with their ability to participate in a standardized rehabilitation program,
- •9. Participated in any other investigational drug or device trial 60 days prior to screening visit or who will receive such a drug or device during the course of this Trial,
- •10. Any previous autograft or allograft revision ACL surgery to either knee,
- •11. Complete absence of the meniscus cartilage in the affected knee, documented by MRI,
- •12. Significant posterior cruciate ligament (PCL) or posterolateral corner ligament injury to the affected knee, documented by examination or MRI,
- •13. Potential Subjects with a known pork food sensitivity/allergy,
- •14. Has contraindications for MRI,
- •15. Has a neuromuscular, neurosensory, or musculoskeletal deficiency that limits the ability to perform objective functional assessment of either knee, such that a Subject experienced polytrauma and/or either lower extremity is immobilized to assess knee stability,
- •16. Potential Subject who is obese or above a Body Mass Index (BMI) of >40 (BMI =kg/m2). See Appendix D.
- •17. Treatment for any condition during the same procedure, such as an acute cartilage injury, that will modify the ACL rehabilitation protocol.
- •18. Subjects who plan to return to competitive sports activities within 9 months post surgery
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