Prospective Trial of Arthroscopic Meniscectomy for Degenerative Meniscus Tears

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关节镜下半月板切除术治疗退行性半月板撕裂与非半月板切除术的手术对照是否有益。关节镜下半月板切除术是退伍军人管理局系统和全国最常见的骨科手术之一。在我们的实践中，80%的半月板撕裂患者接受膝关节镜检查，年龄在45-70岁之间，其中53%的患者有退行性半月板撕裂，没有大的不稳定的皮瓣。这些数据与其他情况下的关节镜半月板切除术数据具有可比性。然而，在退行性半月板撕裂的患者中，关节镜下半月板切除术的短期益处和长期后果仍然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，关节镜下清理术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。本课题组还发现，临床成功的关节镜下内侧后半月板切除术患者在行走过程中膝关节的旋转运动发生了明显的变化。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，关于关节镜下半月板切除术治疗退行性半月板撕裂的临床益处和科学依据，仍有一些关键的未回答的问题。为了解决这些问题，该项目将对45岁至70岁的稳定性退行性半月板撕裂患者进行关节镜下半月板切除术的前瞻性、随机、盲法和对照研究。在这项研究中，对照组将对一组患者进行关节镜下关节灌洗，但不清创稳定的退行性半月板撕裂。这些目标将致力于关节镜下半月板切除术的临床(自我报告)和科学结果(功能)在手术后持续两年的时间框架内。目的1：在稳定性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临床效果。假设1a：在术后12个月，半月板切除组和非半月板切除/灌洗组之间的WOMAC评分将有显著差异。假设1b：术后12个月，非半月板切除/灌洗组的WOMAC评分不低于半月板切除组的WOMAC评分目的2：测试关节镜下半月板切除术对退行性半月板撕裂的作用效果。假设2：与随机接受关节镜检查和半月板切除术的受试者相比，随机接受关节镜检查和半月板切除术的受试者在术后12个月的胫股旋转度、膝关节内收力矩和膝关节屈曲力矩方面有更大的变化。我们还将追求其他探索性目标，旨在从临床、生物学和放射学角度理解和描述早期骨关节炎的进展。这种前瞻性、协调、多学科的方法将为关节镜下半月板切除术提供重要的临床和科学评估，这将改善退行性半月板撕裂的治疗计划。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。

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.