- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07362849
Construction and Application of the Whole Course Management Scheme for Knee Arthroscopic Ligament Surgery Patients Based on "Internet +"
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: lifang li shao
- Phone Number: 0086+13757195875
- Email: 850799313@zju.edu.cn
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Orthopedic knee arthroscopic ligament surgery patients; Age range: 18-60 years old; Informed consent from participants in this study; Internet is available at home, and patients and their families can skillfully use mobile WeChat and other functions.
Exclusion Criteria:
Those who give up halfway or have difficulty cooperating to complete the exercise; I am currently participating in other clinical trials that may have an impact on this study; Having a clear history of mental illness and epilepsy in the past; Postoperative complications such as fractures and rheumatoid arthritis (such as thrombosis or osteomyelitis) are present; Lower extremity deep vein thrombosis;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: The control group patients were treated and managed using conventional diagnosis and treatment metho
On the basis of the conventional diagnosis and treatment mode, the experimental group added an application program for closed-loop management of the entire course of the disease.
Within 24 hours of admission, orthopedic specialist nurses conducted personal evaluations of patients, mainly observing their level of importance for postoperative functional exercise, compliance with patients and their families, intention towards the application program, setting personalized goals, providing health guidance, and improving patients' awareness of rehabilitation needs.
Teach patients to proficiently use the program's educational video viewing function, function exercise video classification query, upload function exercise videos, view medical feedback, and pay attention to questionnaire filling for in-hospital and post hospital health management.
During home stay, orthopedic specialist nurses and rehabilitation therapists conduct weekly assessments of exercise compliance and functional status i
|
Teach patients to proficiently use the program's educational video viewing function, function exercise video classification query, upload function exercise videos, view medical feedback, and pay attention to questionnaire filling for in-hospital and post hospital health management.
|
|
No Intervention: Control Group
The control group patients were treated and managed using conventional diagnosis and treatment methods, followed up by telephone calls and follow-up questionnaire surveys for intervention.
Routine discharge guidance includes medication guidance, exercise guidance, dietary guidance, and psychological guidance.
It guides patients on the precautions, intervention measures, and follow-up time for self-management at home after discharge.
Patients are followed up once a month by phone or in person, and questionnaire data is collected during follow-up visits.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Report on the measurement of knee flexion range of motion (ROM) values for patients treated with knee arthroscopy
Time Frame: 12 weeks
|
Use a medical protractor to measure, instruct the patient to lie flat and actively/passively flex to the maximum angle of the knee joint, align the medical protractor with the lateral femoral condyle of the knee joint, align the fixed arm with the longitudinal axis of the femur, and move the measuring arm with the longitudinal axis of the tibia.
Record the measurement angle, active range of motion AROM, and passive range of motion PROM
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate daily functional status using Lysholm score after knee arthroscopy treatment
Time Frame: 12 weeks
|
The Lysholm score is used for evaluation, which consists of 8 questions with scores ranging from 0 to 100.
The higher the score, the better the patient's functional status and their tendency towards daily life activities.
|
12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate the high and low levels of relevant participants based on the rehabilitation function exercise compliance scale
Time Frame: 12weeks
|
The compliance of rehabilitation functional exercise was assessed using the Orthopedic Patient Functional Exercise Compliance Scale developed by Tan Yuanyuan et al.
The total score of this scale is 75 points, with ≤ 20 points indicating low compliance, 21-54 points indicating partial compliance, and ≥ 55 points indicating high compliance.
The Cronbach's alpha coefficient of the scale is 0.930, and the content validity index is 0.936, which can be used to evaluate the compliance of orthopedic patients with rehabilitation functional exercise.
|
12weeks
|
|
Evaluate the quality of life level of relevant participants based on the quality of life questionnaire scale
Time Frame: 12weeks
|
This study adopts its Chinese version, which includes 5 functional domains, 1 overall quality of life domain, and 9 symptom domains.
A higher score in the first two areas indicates a better quality of life, while a higher score in the last area indicates a poorer quality of life.
This scale is widely used and has good reliability and validity.
|
12weeks
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Bowman EN, Limpisvasti O, Cole BJ, ElAttrache NS. Anterior Cruciate Ligament Reconstruction Graft Preference Most Dependent on Patient Age: A Survey of United States Surgeons. Arthroscopy. 2021 May;37(5):1559-1566. doi: 10.1016/j.arthro.2021.01.042. Epub 2021 Feb 1.
- Briggs KK, Lysholm J, Tegner Y, Rodkey WG, Kocher MS, Steadman JR. The reliability, validity, and responsiveness of the Lysholm score and Tegner activity scale for anterior cruciate ligament injuries of the knee: 25 years later. Am J Sports Med. 2009 May;37(5):890-7. doi: 10.1177/0363546508330143. Epub 2009 Mar 4.
- Backer HC, Wu CH, Schulz MRG, Weber-Spickschen TS, Perka C, Hardt S. App-based rehabilitation program after total knee arthroplasty: a randomized controlled trial. Arch Orthop Trauma Surg. 2021 Sep;141(9):1575-1582. doi: 10.1007/s00402-021-03789-0. Epub 2021 Feb 6.
- Li Y, Gu Z, Ning R, Yin H. Study on the effect of internet plus continuous nursing on functional recovery and medication compliance of patients with knee joint replacement. J Orthop Surg Res. 2023 Jun 11;18(1):424. doi: 10.1186/s13018-023-03907-1.
- [13]MA Z L, HUANG Y G, GU X P, et al. Expert consensus on anethesia management of enhanced recovery after adult ambulatory surgery[J]. Medical Journal of Peking Union Medical College Hospital, 2019, 10(6): 562-569. Chinese
- Jones D, Duffy ME, Flanagan J. Randomized clinical trial testing efficacy of a nurse-coached intervention in arthroscopy patients. Nurs Res. 2011 Mar-Apr;60(2):92-9. doi: 10.1097/NNR.0b013e3182002e46.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- KY-2025-154
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Patients Undergoing Knee Arthroscopic Ligament Surgery
-
Sakarya UniversityRecruitingPatients Undergoing Arthroscopic Knee SurgeryTurkey (Türkiye)
-
Hainan Medical CollegeThe Second Affiliated Hospital of Hainan Medical UniversityCompletedKnee Arthroscopic Surgery | Patients Eligible for Elective Lower Extremity Femoral Nerve SurgeryChina
-
Healthpoint HospitalUnknownArthroscopic Knee Ligament ReconstructionUnited Arab Emirates
-
Shaare Zedek Medical CenterUnknownPatients Undergoing Open Heart Surgery | Patients Undergoing Lung SurgeryIsrael
-
University of LiegeUnknownSurgery of Arthroscopic Anterior Cruciate Ligament RepairBelgium
-
Taipei Medical University WanFang HospitalUnknownKnee Arthroscopic SurgeryTaiwan
-
University of Missouri-ColumbiaCompletedArthroscopic Knee SurgeryUnited States
-
Hospital for Special Surgery, New YorkCompletedArthroscopic Knee SurgeryUnited States
-
Philipps University Marburg Medical CenterTerminatedPatients Undergoing SurgeryGermany
-
Yonsei UniversityUnknownPatients Undergoing SurgeryKorea, Republic of
Clinical Trials on Added applications for closed-loop management of the entire disease course
-
University Hospital, Basel, SwitzerlandWithdrawnAvascular Necrosis of the Femoral Head
-
Steffen PaschenUniversity Hospital Schleswig-Holstein; Czech Technical University in Prague; Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC) and other collaboratorsRecruitingParkinson Disease | Impulse Control DisorderGermany, Netherlands, Switzerland
-
Azienda Sanitaria Locale Napoli 2 NordCompletedObesity, Morbid | Weight Regain | Obesity & OverweightItaly
-
University of KielUniversity of Pennsylvania; University Hospital Schleswig-Holstein; Czech Technical... and other collaboratorsRecruitingParkinson Disease | Impulse Control DisordersGermany, Netherlands, Switzerland