Prospective Trial of Arthroscopic Meniscectomy for Degenerative Meniscus Tears

关节镜半月板切除术治疗退行性半月板撕裂的前瞻性试验

• 批准号: 8590135
• 负责人: Nicholas Giori
• 金额: --
• 依托单位: VETERANS ADMIN PALO ALTO HEALTH CARE SYS
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-10-01 至 2017-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8590135
• 关键词: Address; Age; Area; Arthritis; Arthroscopic Surgical Procedures; Arthroscopy; Biological; Blinded; Cartilage; Cartilage Matrix; Clinical; Clinical Trials; Complement; Control Groups; Controlled Study; Cost Savings; Data; Debridement; Degenerative polyarthritis; Development; Diffusion Magnetic Resonance Imaging; Future; Gene Expression Alteration; Goals; Healthcare Systems; Inferior; Irrigation; Joints; Knee; Magnetic Resonance Imaging; Maps; Measures; Medial; Meniscus structure of joint; Motion; Muscle; Operative Surgical Procedures; Orthopedic Surgical Procedures; Pain; Patient Care; Patient Self-Report; Patients; Placebos; Positioning Attribute; Procedures; Published Comment; Randomized; Relative (related person); Risk; Rotation; Sodium; Surgical Flaps; System; Testing; Thick; Time; Uncertainty; Walking; age group; articular cartilage; base; complement system; cost; functional outcomes; functional restoration; gait examination; improved; insight; prospective; public health relevance; response; soft tissue; treatment planning

DESCRIPTION (provided by applicant): The overall goal of this project is to determine whether arthroscopic meniscectomy in degenerative meniscal tears is beneficial from a clinical and scientific viewpoint relative to a non-meniscectomy surgical control. Arthroscopic meniscectomy is among the most commonly performed orthopedic surgical procedures in the VA system and nationally. 80% of patients in our practice having knee arthroscopy for meniscus tears have been in the 45-70 years age group and 53% of these patients had degenerative meniscal tears without a large unstable flap. These data are comparable of arthroscopic meniscectomy data drawn in other settings. However, there remains substantial uncertainty regarding the short term benefits and the long term consequences of arthroscopic meniscectomy in patients with degenerative meniscus tears. Degenerative meniscus tears are associated with osteoarthritis, and it is known that within two years of surgery, arthroscopic debridement for osteoarthritis is no better than placebo in relieving pain and restoring function. Longer term, meniscectomy has been shown to be associated with elevated risk of osteoarthritis development, raising the concern that meniscectomy can actually be harmful. It has also been shown by our group that patients with clinically successful arthroscopic posterior medial meniscectomy have significant change in the rotational motion of the knee during walking. Rotational changes at the knee follow soft tissue damage and have been implicated in the causes for cartilage degeneration. Thus there are critical unanswered questions regarding the clinical benefit as well as the scientific basis for arthroscopic meniscectomy for degenerative meniscal tear. To address these questions this project will conduct a prospective, randomized, blinded, and controlled study of arthroscopic meniscectomy in patients between the ages of 45 and 70 with stable degenerative meniscus tears. In this study, the control group will be a group of patients having arthroscopic lavage of the joint, but no debridement of a stable degenerative meniscus tear. The Aims will address clinical (self-reported) and scientific outcomes (functional) of arthroscopic meniscectomy in the time frame lasting up to two years after surgery. Aim 1: Test the clinical benefit of arthroscopic meniscectomy in the setting of a stable degenerative meniscus tear. Hypothesis 1a: There will be significant differences in WOMAC scores between the Meniscectomy and the Non-Meniscectomy/Lavage Groups at 12 months after surgery. Hypothesis 1b: The WOMAC scores of the Non-Meniscectomy/Lavage group will not be inferior to the WOMAC scores of the Meniscectomy group at 12 months after surgery Aim 2: Test the functional effect of arthroscopic meniscectomy in the setting of a degenerative meniscus tear. Hypothesis 2: Subjects randomized to arthroscopy and meniscectomy will have greater changes in tibio- femoral rotation, knee adduction moment, and knee flexion moment at 12 months following surgery when compared to subjects randomized to arthroscopy and lavage. We will also pursue other exploratory aims that are oriented towards understanding and characterizing the progression of incipient osteoarthritis from a clinical, biological, and radiographic standpoint. This prospective coordinated, multi-disciplinary approach will provide an important clinical and scientific assessment of arthroscopic meniscectomy that will improve treatment planning for degenerative meniscal tears. It will also provide new insight into incipient arthritis, yielding important information that will impact future patient care.

描述（由申请人提供）： 本项目的总体目标是从临床和科学角度确定退行性膝关节撕裂的关节镜下踝关节切除术是否有益于非踝关节切除术手术对照。关节镜下椎间盘切除术是VA系统和全国最常进行的骨科手术之一。在我们的实践中，80%的半月板撕裂膝关节镜手术患者年龄在45-70岁之间，其中53%的患者患有退行性半月板撕裂，没有大的不稳定皮瓣。这些数据与其他情况下的关节镜下椎间盘切除术数据相当。然而，在退行性半月板撕裂患者中，关节镜下半月板切除术的短期受益和长期后果仍存在很大的不确定性。退行性半月板撕裂与骨关节炎有关，众所周知，在手术后两年内，关节镜下清创治疗骨关节炎在缓解疼痛和恢复功能方面并不比安慰剂好。从长远来看，半月板切除术已被证明与骨关节炎发生的风险增加有关，这引发了人们对半月板切除术实际上可能有害的担忧。我们的研究小组还表明，临床成功的关节镜下后内侧半月板切除术患者在行走时膝关节旋转运动有显著变化。膝关节的旋转变化伴随着软组织损伤，并与软骨退化的原因有关。 因此，关于关节镜下椎间盘切除术治疗退行性椎间盘撕裂的临床受益以及科学依据，存在关键的未回答问题。为了解决这些问题，本项目将在45至70岁的稳定退行性半月板撕裂患者中进行一项关节镜下半月板切除术的前瞻性、随机、设盲和对照研究。在本研究中，对照组将是一组接受关节镜灌洗但不对稳定退行性半月板撕裂进行清创的患者。目标将在术后长达两年的时间范围内讨论关节镜下椎间盘切除术的临床（自我报告）和科学结局（功能）。目的1：测试关节镜下半月板切除术在稳定退行性半月板撕裂中的临床受益。 假设1a：术后12个月时，半月板切除术组和非半月板切除术/灌洗组的WOMAC评分存在显著差异。 假设1b：术后12个月时，非半月板切除术/灌洗组的WOMAC评分将不劣于半月板切除术组的WOMAC评分目的2：在退行性半月板撕裂的情况下测试关节镜下半月板切除术的功能效果。 假设二：与随机接受关节镜检查和灌洗的受试者相比，随机接受关节镜检查和椎间盘切除术的受试者在术后12个月时胫股旋转、膝关节内收力矩和膝关节屈曲力矩的变化更大。我们还将追求其他探索性目标，从临床、生物学和放射学角度理解和表征早期骨关节炎的进展。这种前瞻性协调的多学科方法将为关节镜下椎间盘切除术提供重要的临床和科学评估，从而改善退行性椎间盘撕裂的治疗计划。它还将为早期关节炎提供新的见解，产生将影响未来患者护理的重要信息。