A Prospective, Non-randomized, Multi-Center Investigation of All-suture-based Repair of Horizontal Meniscal Tears (STITCH Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 16
- 主要终点
- Freedom From Re-operation of the Index Meniscus Repair Site (Incidence of Subjects Requiring Re-operation)
研究概览
简要总结
Horizontal meniscus tears meeting specified criteria will be repaired by any commonly used suture technique. Subjects will be followed for 2 years to evaluate the effectiveness of the repair, by assessing the re-operation rate, and by assessing improvements in knee pain and knee function.
详细描述
Potential subjects will undergo Screening for eligibility based on Inclusion/Exclusion criteria. Screening will include an x-ray of the injured knee and evaluation of an MRI of the injured knee within 6 months prior to the scheduled procedure. During the procedure, the meniscal tear will be evaluated by arthroscopy to determine if the tear meets study requirements. If the meniscal tear is determined to meet inclusion/exclusion criteria, the subject will be considered enrolled. If any inclusion/exclusion criteria is not met, the subject will be considered a screen failure and will not be enrolled. For enrolled subjects, specific information regarding the repair and repair technique will be collected during the procedure, including still and video images.
Subjects will be contacted 7-15 days post-procedure for safety follow-up. Subjects will return for follow-up visits at approximately post-procedure Days 90, 185, 365 and 730. Identical questionnaires will be completed at each visit to assess knee pain and knee function. Safety information will be collected at each post-procedure visit. Additionally, an in-office arthroscopy of the treated knee will be performed at participating sites at Day 185, an MRI of the treated knee will be performed at Day 365 and an X-ray of the treated knee will be performed at Day 730. The patient will exit the study at the Day 730 visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of either gender may be eligible for inclusion in the study only if they meet all of the following criteria:
- •Able and willing to give informed consent by voluntarily providing written informed consent in accordance with governing Institutional Review Board
- •18 to 60 years of age, inclusive at the time of screening;
- •History indicative of meniscal pathology (e.g., pain, mechanical symptoms described as locking, clicking or giving way);
- •Physical exam consistent with meniscus tear (e.g., locked joint, joint line tenderness and/or pain on meniscal compression);
- •If prior ligament reconstruction, the study knee is clinically stable;
- •Preoperative MRI evidence within 6 months consistent with a horizontal/radial/oblique meniscus tear in the symptomatic compartment
- •Arthroscopy Inclusion Criteria:
- •Consented subjects may be included in the study only if, upon arthroscopic inspection, their meniscal study lesion meets all of the following criteria established by the International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine (ISAKOS) (see Appendix 1):
- •Zone location: circumferential location of tear includes locations within 10mm of the peripheral rim of the meniscus;
- •Radial location: any location from anterior to posterior;
- •Tear pattern: primarily horizontal or oblique in orientation (not to exceed 45 degrees from horizontal);
- •Compartment: either lateral or medial, but not both;
- •Opposite compartment meniscal tear (if present) limited to the central portion (i.e., Zone 3/"white zone");
- •Tear amenable to repair with all suture-based techniques.
排除标准
- •Subjects will be excluded from the study for any of the following reasons:
- •Arthritis in the study knee (Kellgren-Lawrence Grade 3 or higher [See Appendix 4]);
- •Body Mass Index (BMI) ≥35 kg/m2;
- •Previous meniscal repair or meniscectomy of the study meniscus;
- •Unstable knee;
- •Malalignment (> 5 degrees) of the study knee, based on X-ray within 6 months requiring osteotomy and/or requiring correction;
- •History of constitutional/systemic inflammatory/arthritic problem or pain condition, history of knee infection, vascular condition of legs, benign neoplasms of knee, hepatitis, HIV, drug/alcohol abuse, tobacco use, cancer;
- •Expected to undergo any other primary treatment of the knee;
- •Any concomitant painful or disabling disease, condition or post-procedure status of either lower extremity that would interfere with evaluation or rehabilitation of the study knee.
- •Pregnant or planning to become pregnant in the next 2 years.
- •Arthroscopy Exclusion Criteria:
- •Subjects will be excluded from the study if their study meniscus lesion meets any of the following criteria at arthroscopy:
- •Tear pattern: primarily vertical longitudinal in orientation;
- •Partial meniscectomy of any portion of the study meniscus extends beyond the central portion (i.e., Zone 3/"white zone");
- •Intact or partially intact meniscus tear that, in the opinion of the Investigator, does not require repair;
- •Poor meniscal tissue quality such that it will not hold a suture;
- •Any portion of the meniscus repair that, in the opinion of the Investigator, is best treated using an implant other than suture;
- •Bicompartmental Zone 1/"red zone" and/or Zone 2/"red-white zone" meniscal tears;
- •Performance of a significant concomitant procedure intended as a therapeutic intervention on the study knee;
- •Arthritis in the surgical knee (International Cartilage Research Society [ICRS] Grade 3b or higher or Modified Outerbridge Grade III or higher)
结局指标
主要结局
Freedom From Re-operation of the Index Meniscus Repair Site (Incidence of Subjects Requiring Re-operation)
时间窗: 6 months, 1 year, and 2 years
Occurrence of any re-operation of study knee to treat previously repaired meniscal tear during the 2 years following the study procedure.
次要结局
- Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Quality of Life (QOL) Score at 3 Months, 6 Months, 1 Year, and 2 Years(Baseline, 3 months, 6 months, 1 year, 2 years)
- Change in Knee Pain and Function by Completion of International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC Knee Evaluation) at 3 Months, 6 Months, 1 Year, and 2 Years(Baseline, 3 months, 6 months, 1 year, and 2 years)
- Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Pain Score at 3 Months, 6 Months, 1 Year, and 2 Years(Baseline, 3 months, 6 months, 1 year, 2 years)
- Change in Knee Pain and Function by Lysholm Knee Questionnaire at 3 Months, 6 Months, 1 Year, and 2 Years(Baseline, 3 months, 6 months, 1 year, and 2 years)
- Change in Knee Pain and Function by Tegner Activity Scale at 3 Months, 6 Months, 1 Year, and 2 Years(Baseline, 3 months, 6 months, 1 year, and 2 years)
- Change in Daily Living (ADL) Score at 3 Months, 6 Months, 1 Year, and 2 Years(Baseline, 3 months, 6 months, 1 year, 2 years)
- Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Sport and Recreation Function (Sport) Score at 3 Months, 6 Months, 1 Year, and 2 Years(Baseline, 3 months, 6 months, 1 year, 2 years)
- Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Symptom Score at 3 Months, 6 Months, 1 Year, and 2 Years(Baseline, 3 months, 6 months, 1 year, 2 years)