Clinical Outcomes and Associated Factors Following Arthroscopic Surgeries for Shoulder and Knee Sports Injuries: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Patient-Reported Outcome Measures (PROMs) for Joint Function
研究概览
简要总结
This observational study aims to evaluate the long-term recovery and clinical outcomes of patients undergoing minimally invasive (arthroscopic) surgeries for sports-related shoulder and knee injuries.
Sports injuries, such as ligament tears, meniscus damage, and rotator cuff tears, are common and can significantly impact a person's daily life and ability to return to sports. While surgery is an effective treatment, the recovery process and final outcomes can vary greatly from person to person.
Researchers will follow patients who are already scheduled for routine shoulder or knee surgery at the study center. By collecting detailed information about the patient's initial injury, the specific surgical techniques used by the doctor, and the patient's recovery progress over two years, the study hopes to identify which factors lead to the best healing and functional outcomes.
Participants will be asked to complete standard questionnaires about their joint function and pain levels before their surgery, and again at 6 months, 1 year, and 2 years after surgery. The study is strictly observational; it will not change the standard medical care, surgical plan, or rehabilitation routine the patients receive.
详细描述
Despite significant advancements in arthroscopic techniques for shoulder and knee sports injuries (e.g., anterior cruciate ligament reconstruction, meniscus repair, and rotator cuff repair), postoperative clinical outcomes and return-to-sport rates remain highly variable among individuals. This variability is likely influenced by a complex interplay of patient baseline characteristics, specific tear morphologies, individualized intraoperative surgical choices (e.g., mechanical augmentation strategies, remnant preservation), and post-operative rehabilitation.
This single-center, prospective observational cohort study is designed to systematically collect high-granularity clinical data from patients undergoing elective arthroscopic shoulder and knee surgeries. The study will construct a structured registry that integrates highly detailed intraoperative objective assessments with standardized Patient-Reported Outcome Measures (PROMs).
The primary objective is to evaluate the mid-to-long-term functional outcomes and utilize multivariable regression models to identify independent predictive factors for success or sub-optimal recovery. Additionally, the study involves the ethical collection of discarded intraoperative tissues (e.g., synovial fluid, degenerative tendon/cartilage fragments) and residual routine blood samples. This will establish a biobank to support future "clinical-basic" translational research exploring the microenvironment of tissue healing.
By establishing this comprehensive real-world database, the investigators aim to provide robust evidence to help resolve ongoing clinical controversies in sports medicine and ultimately optimize personalized surgical and rehabilitation protocols.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 8 years.
- •No gender restrictions.
- •Definitive diagnosis of shoulder or knee sports injuries or related joint conditions.
- •Scheduled to undergo elective, standard-of-care surgery at the study center (procedures include but are not limited to: arthroscopic meniscus repair/meniscectomy, cartilage repair, cruciate ligament reconstruction, high tibial osteotomy [HTO], unicompartmental knee arthroplasty [UKA], arthroscopic rotator cuff repair, shoulder stabilization, and shoulder arthroplasty).
- •Clear consciousness, with the ability to read, understand, and communicate.
- •Willing and able to comply with postoperative follow-up requirements.
- •Voluntarily signed the written informed consent form.
排除标准
- •Patients requiring emergency surgery due to acute, severe trauma (e.g., open fractures, polytrauma).
- •Coexisting severe neurological or psychiatric diseases, or cognitive impairment that prevents understanding of the informed consent or cooperation with follow-up.
- •Patients in an involuntary state (e.g., under coercion).
- •Refusal to sign the informed consent form or refusal to participate in the study.
- •Currently participating in other interventional clinical trials that may confound or affect the clinical outcomes of this study.
研究组 & 干预措施
Knee Cohort
Patients diagnosed with sports-related knee injuries (e.g., ACL rupture, meniscus tear) who are scheduled to undergo elective, standard-of-care knee arthroscopic surgery.
干预措施: Standard of Care Knee Arthroscopy (Procedure)
Shoulder Cohort
Patients diagnosed with sports-related shoulder injuries (e.g., rotator cuff tear, shoulder instability) who are scheduled to undergo elective, standard-of-care shoulder arthroscopic surgery.
干预措施: Standard of Care Shoulder Arthroscopy (Procedure)
结局指标
主要结局
Patient-Reported Outcome Measures (PROMs) for Joint Function
时间窗: Preoperative baseline, 2 weeks, 1 month, 6 months, 1 year, and 2 years postoperatively.
Validated questionnaires evaluate function, symptoms, and QoL based on the specific cohort. 1. Higher scores indicate better outcomes (better function / less symptoms): Score 0 to 100: IKDC, Pedi-IKDC, KOOS, ACL-RSI, WOMET, Kujala AKPS, BPII 2.0, ASES, Rowe score, and EQ-5D VAS. Score 0 to 48: OSIS (Oxford Shoulder Instability) and OSS (Oxford Shoulder). Score 0 to 10: Tegner Activity Scale (higher = higher activity level). Score 0 to 16: Marx Activity Scale (higher = higher activity level). 2. Lower scores indicate better outcomes (less pain / less disability): Score 0 to 10: VAS and NRS (for pain). Score 0 to 100: Quick-DASH (upper extremity disability).
次要结局
- Incidence of Postoperative Complications(From the date of surgery up to 2 years postoperatively.)
- Pain Intensity Assessed by Visual Analog Scale (VAS)(Preoperative baseline, 2 weeks, 1 month, 6 months, 1 year, and 2 years postoperatively.)