NL-OMON53168已完成不适用
A Prospective and Consecutive Clinical Evaluation of Soft Tissue Regeneration*s L-C Ligament® in Primary ACL Reconstruction - L-C Ligament
Biorez, Inc.0 个研究点目标入组 15 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
- •18 to 45 years of age.
- •Males and females.
- •If female, for the 24 months post-operative, actively practicing a
- •contraception method, or surgically sterilised or
- •postmenopausal.
- •Acute unilateral ACL tear, or partial or complete tear of the ACL
- •that occurred within 91 days (13 weeks) of injury, and requires
- •reconstruction of the ACL.
- •Passive flexion - 120° and passive extension on the target knee
- •is the same as the contralateral knee.
- •Patients with all types of lateral and/or medial meniscal tears
- •which are repairable.
- •Medial Collateral Ligament (MCL) grade 2 or less.
- •Potential Subject is able to provide informed consent and must
- •sign the EC-approved Informed Consent Form
- •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
排除标准
- •Prior ACL reconstruction or other surgical procedure on the
- •affected (target) knee.
- •Chronic ACL injury; interventional surgery scheduled 92 days or
- •more after ACL injury.
- •Professional athletes currently engaged in active sport
- •Prior fracture of the affected (target) leg
- •Previous or current ACL injury on contra-lateral leg.
- •Multi-ligament reconstruction.
- •Malalignment with varus thrust
- •Patient > 193 cm tall (6* 4*).
- •The patient does not follow pre-operative rehabilitation.
- •Confirmed connective tissue disorder.
- •Signs of moderate to severe degenerative joint disease
- •(Osteoarthritis)
- •Concomitant injuries to the knee or lower extremities requiring
- •treatment, per surgeon's discretion.
- •Severe pain, swelling, or redness within 24 hours prior to
- •Complete or partial Post Cruciate Ligament (PCL) tear.
- •Any of the following: 1/3rd meniscal resection; complex doublebucket
- •tear; partially repaired meniscal tears.
- •Patient requires treatment of articular cartilage on target leg
- •The patient is mentally compromised.
- •The patient has a neuromuscular disorder that would engender
- •unacceptable risk of knee instability, prosthesis fixation failure,
- •or complications in postoperative care.
- •The patient has a diagnosed systemic disease that would affect
- •his/her safety or the study outcome.
- •The patient has an active or latent infection in or about the
- •affected knee joint or an infection site distant from the knee that
- •may spread to the knee hematogenously.
- •Pregnant based on a positive beta hCG serum or an in vitro
- •diagnostic test result or breast-feeding.
- •The patient is obese with a BMI ³ 35.
- •The patient has a known allergy to PLLA.
- •The patient has a medical condition or comorbidity that would
- •interfere with study participation.
研究者
相似试验
尚未招募
不适用
ROLE OF HOMOEOPATHIC MEDICINE IN DIABETES MELLITUS 2CTRI/2022/01/039691SUNIL THUMAR
招募中
不适用
Prospective observational study evaluating clinical significance of serial quantification of PCT in respiratory diseasesRespiratory diseasesJPRN-UMIN000012727Respiratory Medicine Division, Fukujuji Hospital500
招募中
不适用
A prospective and observational clinical investigation evaluating the clinical outcomes of unstable distal radius fractures treated by the dynamic external fixator Galaxy WristS60-S69Injuries to the wrist and handDRKS00006758Orthofix Srl, , Bussolengo (Verona), Italy120
已完成
不适用
Prospective clinical study to evaluate the clinical performance of immediately placed PL implants: A monocenter studyK08.1Loss of teeth due to accident, extraction or local periodontal diseaseDRKS00016500Johann Wolfgang Goethe Universität FrankfurtZentrum der Zahn-, Mund- und KieferheilkundeCarolinum Zahnärztliches Universitäts-Institut gGmbHPoliklinik für Zahnärztliche Chirurgie und Implantologie25
招募中
不适用
Prospective clinical study to evaluate the clinical performance of immediately placed Astra DS Prime Taper implants:A monocenter studyK08.1Loss of teeth due to accident, extraction or local periodontal diseaseDRKS00025234Goethe Universität Frankfurt, Zentrum der Zahn-, Mund- und Kieferheilkunde (Carolinum), Zahnärztliches Universitäts-Institut gGmbH, Poliklinik für Zahnärztliche Chirurgie und Implantologie25