Clinical Outcomes of Arthroscopic Surgeries for Shoulder and Knee Sports Injuries (SK-COHORT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Injuries; Anterior Cruciate Ligament Injuries; Shoulder Dislocation or Subluxation; Posterior Cruciate Ligament Tear; Tibial Meniscus Injuries; Athletic Injuries (C26.857.500.124)
• Intervention / Treatment: Procedure: Standard of Care Shoulder Arthroscopy; Procedure: Standard of Care Knee Arthroscopy

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Yan Xiong, Doctor; Phone Number: 0571-663553; Email: xiongyanbear@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
      • Contact: Yan Xiong, Doctor; Phone Number: 0571-663553; Email: xiongyanbear@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: 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.
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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Reported Outcome Measures (PROMs) for Joint Function	Validated questionnaires evaluate function, symptoms, and QoL based on the specific cohort.; 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).; 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).	Preoperative baseline, 2 weeks, 1 month, 6 months, 1 year, and 2 years postoperatively.

Secondary Outcome Measures

Outcome Measure	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.
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.

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Chair: Yan Xiong, Doctor, Department of Orthopedic Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China; Principal Investigator: Weijun Li, Master, Department of Orthopedic Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2026
• Primary Completion (Estimated): April 7, 2046
• Study Completion (Estimated): April 7, 2046

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Arthroscopy; Sports Medicine; Patient Reported Outcome Measures; Clinical Outcomes; Prospective Cohort
• Additional Relevant MeSH Terms: Shoulder Injuries; Musculoskeletal Diseases; Wounds and Injuries; Joint Diseases; Leg Injuries; Rupture; Tendon Injuries; Knee Injuries; Rotator Cuff Injuries; Anterior Cruciate Ligament Injuries; Tibial Meniscus Injuries; Joint Dislocations; Shoulder Dislocation; Athletic Injuries
• Other Study ID Numbers: 2025-1394

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No