Prospective Trial of Arthroscopic Meniscectomy for Degenerative Meniscus Tears
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Average Rotation During Stance
研究概览
简要总结
Arthroscopic meniscectomy is among the most commonly performed orthopedic surgical procedures in the VA system. There remains substantial uncertainty, however, regarding the short term benefits and the long term consequences of arthroscopic meniscectomy in patients with degenerative meniscus tears. Of major concern is the fact that 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. The purpose of this study is to determine whether meniscectomy in the setting of a degenerative meniscus tear is of any clinical value. Determining this would either justify the expenses associated with arthroscopic meniscectomy on a large number of patients, or would identify an area of significant potential cost savings.
详细描述
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 arthroscopy control. Arthroscopic meniscectomy is among the most commonly performed orthopedic surgical procedures in the VA system and nationally. In the investigators' practice at the VA Palo Alto Healthcare System over the last year, 80% of patients 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 to arthroscopic meniscectomy data drawn in other settings. While meniscectomy is a common procedure there remains substantial uncertainty regarding the short term benefits and the long term consequences of arthroscopic meniscectomy in patients with degenerative meniscus tears. Of major concern is the fact that 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 the 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 the stable degenerative meniscus tear. The aims will address clinical (self-reported) and scientific (functional) outcomes 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 a significant differences in WOMAC scores between the meniscectomy and the non-meniscectomy/lavage groups at 12 months following 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 45 and 70 years
- •Degenerative meniscus tear as seen on standard clinical MRI scan
- •Complaint of "mechanical symptoms" which would include popping, catching, or locking of the knee
- •Persistent symptoms for a minimum of three months despite conservative management
- •Patient is enrolled for arthroscopic meniscectomy
- •Subject agrees to the study follow-up schedule and signs informed consent.
排除标准
- •Radiographic osteoarthritis of the knee in any compartment greater than KL grade 2
- •Prior knee arthroscopy within two years of study enrollment
- •Unable to have an MRI scan
- •Does not agree to participate
结局指标
主要结局
Average Rotation During Stance
时间窗: Two years post baseline
Degree of external tibial rotation averaged over the stance phase of gait.
Gait Knee Adduction Moment
时间窗: Two year post baseline
Knee adduction moment describes the medial/lateral load distribution of the knee measured while walking in a gait laboratory. Before normalization to account for size, the knee adduction moment is expressed in Nm. However, to account for different sized people, the knee adduction moment is transformed and expressed in percentage of body weight times height (%BW\*ht). Higher knee adduction moments have been linked to more severe osteoarthritis (OA).
WOMET Score
时间窗: two years post baseline
Western Ontario Meniscal Evaluation Tool (WOMET) is a standardized and validated survey used to evaluate the pain and function of patients with a degenerative meniscal tear. The survey consists of 16 questions regarding physical symptoms, sports/recreation/work/lifestyle, and emotions. Each question is answered via a visual analog scale (VAS) of 0-100mm for a total score of 1600, where higher numbers are worse. The score is then transformed into a percentage, where 0 is the worst pain and functioning and 100% is no pain and fully functioning.
次要结局
- KOOS Pain Score(one year post baseline)
- TNFa(Baseline)
