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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care Shoulder Arthroscopy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-Reported Outcome Measures (PROMs) for Joint Function | Validated questionnaires evaluate function, symptoms, and QoL based on the specific cohort.
Score 0 to 10: VAS and NRS (for pain). Score 0 to 100: Quick-DASH (upper extremity disability). | Preoperative baseline, 2 weeks, 1 month, 6 months, 1 year, and 2 years postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the date of surgery up to 2 years postoperatively. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Xiong, Doctor | Contact | 0571-663553 | xiongyanbear@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yan Xiong, Doctor | Department of Orthopedic Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China | Study Chair |
| Weijun Li, Master | Department of Orthopedic Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | China |
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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Discarded intraoperative tissues (e.g., synovial fluid, synovial tissue, degenerative meniscus or tendon fragments) and residual routine perioperative blood samples (serum/plasma). These specimens will be retained strictly for histological evaluation, biochemical analysis, and protein/biomarker profiling (e.g., inflammatory cytokines). No DNA extraction or genetic testing will be performed.
|
| Standard of Care Knee Arthroscopy | Procedure | 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. |
|
| 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." | Preoperative baseline, 2 weeks, 1 month, 6 months, 1 year, and 2 years postoperatively. |
| Principal Investigator |
| ID | Term |
|---|---|
| D001265 | Athletic Injuries |
| D000070636 | Rotator Cuff Injuries |
| D000070600 | Tibial Meniscus Injuries |
| D012783 | Shoulder Dislocation |
| D004204 | Joint Dislocations |
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D012421 | Rupture |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
| D007869 | Leg Injuries |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D007718 | Knee Injuries |
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