Clinical Outcomes of Arthroscopic Surgeries for Shoulder and Knee Sports Injuries

Официальное название

Clinical Outcomes and Associated Factors Following Arthroscopic Surgeries for Shoulder and Knee Sports Injuries: A Prospective Cohort Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Standard of Care Shoulder Arthroscopy
  Routine, minimally invasive arthroscopic surgical procedures tailored to the patient's specific shoulder pathology, followed by standard postoperative rehabilitation. This is strictly observational; no experimental procedures are introduced.
• Процедура Standard of Care Knee Arthroscopy
  Routine, minimally invasive arthroscopic surgical procedures tailored to the patient's specific knee pathology, followed by standard postoperative rehabilitation. This is strictly observational; no experimental procedures are introduced.

Первичные конечные точки

• Patient-Reported Outcome Measures (PROMs) for Joint Function [Срок оценки: Preoperative baseline, 2 weeks, 1 month, 6 months, 1 year, and 2 years postoperatively.]

Вторичные конечные точки (2)

• Incidence of Postoperative Complications [Срок оценки: From the date of surgery up to 2 years postoperatively.]
• Pain Intensity Assessed by Visual Analog Scale (VAS) [Срок оценки: Preoperative baseline, 2 weeks, 1 month, 6 months, 1 year, and 2 years postoperatively.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• The Second Affiliated Hospital of Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT07501013 · 2025-1394

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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