Clinical Outcomes of Arthroscopic Surgeries for Shoulder and Knee Sports Injuries

NCT07501013 | Recruiting

• 1 other identifier: 2025-1394
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rotator Cuff Injuries; Tibial Meniscus Injuries; Athletic Injuries (C26.857.500.124); Shoulder Dislocation or Subluxation; Anterior Cruciate Ligament Injuries; Posterior Cruciate Ligament Tear

Keywords

Arthroscopy; Sports Medicine; Patient Reported Outcome Measures; Prospective Cohort; Clinical Outcomes

Outcome Measures

Primary Outcomes (1)

• 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).

  Preoperative baseline, 2 weeks, 1 month, 6 months, 1 year, and 2 years postoperatively.

Secondary Outcomes (2)

• 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.

Study Arms (2)

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

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

Interventions

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.

Shoulder Cohort

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.

Knee Cohort

Eligibility Criteria

• Age: 8 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Athletic Injuries; Rotator Cuff Injuries; Tibial Meniscus Injuries; Shoulder Dislocation; Joint Dislocations; Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Knee Injuries

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Xiong, Doctor

CONTACT

0571-663553; xiongyanbear@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): April 7, 2046
• Study Completion (Estimated): April 7, 2046
• Last Updated: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)