An observational study in Athletic Injuries (C26.857.500.124), Rotator Cuff Injuries and Tibial Meniscus Injuries, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Open to participants aged 8 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational
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.
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.
258 studies on the registry are indexed under Athletic Injuries; 45 are open to participants now.
This study's planned enrollment of 500 is above the median of 100 across 91 observational studies indexed under Athletic Injuries.
Browse Athletic Injuries studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of consecutive real-world patients presenting to the sports medicine clinic or inpatient ward at the study center. These are patients who have been diagnosed with shoulder or knee joint pathologies and are scheduled to receive standard-of-care elective surgical treatments.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Standard of Care Shoulder Arthroscopy
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.
Procedure: Standard of Care Knee 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.
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.
Patient-Reported Outcome Measures (PROMs) for Joint Function
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).
Time frame: Preoperative baseline, 2 weeks, 1 month, 6 months, 1 year, and 2 years postoperatively.
Incidence of Postoperative Complications
Tracking the occurrence rate of any adverse events related to the surgery, including but not limited to surgical site infection, deep vein thrombosis (DVT), severe joint stiffness requiring manipulation, and graft failure or re-rupture requiring revision surgery.
Time frame: From the date of surgery up to 2 years postoperatively.
Pain Intensity Assessed by Visual Analog Scale (VAS)
Assessment of joint pain at rest and during activity using a 10-point Visual Analog Scale, where 0 represents "no pain" and 10 represents "worst imaginable pain."
Time frame: Preoperative baseline, 2 weeks, 1 month, 6 months, 1 year, and 2 years postoperatively.
Plan to share: No — Individual participant data (IPD) will not be shared publicly in order to strictly protect patient privacy and confidentiality. This decision is in accordance with the regulations of our hospital's Institutional Review Board (IRB) and local data security laws. Only highly aggregated, de-identified statistical data will be presented and published in peer-reviewed academic journals.
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Second Affiliated Hospital, School of Medicine, Zhejiang University →