Athletic Injuries (C26.857.500.124)SK-COHORTNCT07501013
Clinical Outcomes of Arthroscopic Surgeries for Shoulder and Knee Sports Injuries
An observational study of Athletic Injuries (C26.857.500.124) and Rotator Cuff Injuries, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 80 years
- Conditions the study is for
- Athletic Injuries (C26.857.500.124), Rotator Cuff Injuries, Tibial Meniscus Injuries
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2026to 7 Apr 2046
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Yan Xiong, Doctor, 0571-663553, xiongyanbear@zju.edu.cn
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Athletic Injuries (C26.857.500.124), Rotator Cuff Injuries, Tibial Meniscus Injuries, Shoulder Dislocation or Subluxation, Anterior Cruciate Ligament Injuries, Posterior Cruciate Ligament Tear
- Being tested
- Standard of Care Shoulder Arthroscopy, Standard of Care Knee Arthroscopy
- Keywords
- Arthroscopy, Sports Medicine, Patient Reported Outcome Measures, Prospective Cohort, Clinical Outcomes
- Medical subject headings
- Athletic Injuries, Rotator Cuff Injuries, Tibial Meniscus Injuries, Shoulder Dislocation, Joint Dislocations, Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care Shoulder ArthroscopyProcedure or surgery
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.
Standard of Care Knee ArthroscopyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Standard of Care Knee Arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Preoperative baseline, 2 weeks, 1 month, 6 months, 1 year, and 2 years postoperatively.
Secondary outcomes (2)
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.
Measured: 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."
Measured: Preoperative baseline, 2 weeks, 1 month, 6 months, 1 year, and 2 years postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start7 Apr 2026
- Primary completion7 Apr 2046 (estimated)
- Study completion7 Apr 2046 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Athletic Injuries (C26.857.500.124)Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Xiong, Doctor, Study chair, Department of Orthopedic Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, ChinaWeijun Li, Master, Principal investigator, Department of Orthopedic Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501013
- Sponsor's protocol ID
- 2025-1394
- Acronym
- SK-COHORT
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes and Associated Factors Following Arthroscopic Surgeries for Shoulder and Knee Sports Injuries: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07501013
- Acronym / sponsor ID
- SK-COHORT / 2025-1394
- Conditions
- Athletic Injuries (C26.857.500.124), Rotator Cuff Injuries, Tibial Meniscus Injuries, Shoulder Dislocation or Subluxation, Anterior Cruciate Ligament Injuries, Posterior Cruciate Ligament Tear
- Keywords
- Arthroscopy, Sports Medicine, Patient Reported Outcome Measures, Prospective Cohort, Clinical Outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- 7 Apr 2046 (estimated)
- Study completion
- 7 Apr 2046 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shoulder Cohort | – | Procedure: Standard of Care Shoulder ArthroscopyPatients 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 | – | Procedure: Standard of Care Knee ArthroscopyPatients diagnosed with sports-related knee injuries (e.g., ACL rupture, meniscus tear) who are scheduled to undergo elective, standard-of-care knee arthroscopic surgery. |
Who may qualify
- Ages
- 8 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care Shoulder ArthroscopyRoutine, 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. | Procedure or surgery | Shoulder Cohort |
| Standard of Care Knee ArthroscopyRoutine, 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. | Procedure or surgery | Knee Cohort |
Primary outcome
Patient-Reported Outcome Measures (PROMs) for Joint Function
Time frame: Preoperative baseline, 2 weeks, 1 month, 6 months, 1 year, and 2 years postoperatively.
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).
2 secondary outcomes
Incidence of Postoperative Complications
Time frame: From the date of surgery up to 2 years postoperatively.
Pain Intensity Assessed by Visual Analog Scale (VAS)
Time frame: Preoperative baseline, 2 weeks, 1 month, 6 months, 1 year, and 2 years postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yan Xiong, Doctor study chair
Department of Orthopedic Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Weijun Li, Master principal investigator
Department of Orthopedic Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Athletic Injuries (C26.857.500.124) and Rotator Cuff Injuries, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Xiong, Doctor (0571-663553, xiongyanbear@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Outcome Measures (PROMs) for Joint Function (time frame: Preoperative baseline, 2 weeks, 1 month, 6 months, 1 year, and 2 years postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.