Discoid Meniscus of KneeNCT07549867
Application of Smart Wearable Device-Based Remote Rehabilitation in Postoperative Recovery After Arthroscopic Surgery for Discoid Meniscus
A study testing Telerehabilitation intervention based on wearable devices and Clinic rehabilitation in people with Discoid Meniscus of Knee, run by West China Hospital.
Trial summary
This study is designed as a single-center, prospective, randomized controlled trial. The aim of this clinical trial is to evaluate the effectiveness, safety, and feasibility of a wearable device-based telerehabilitation approach for postoperative recovery in patients undergoing arthroscopic surgery for discoid… Read more about this study
- Who is it for?
- Ages 10 to 60 years
- Conditions the study is for
- Discoid Meniscus of Knee
- What is being tested?
- Telerehabilitation intervention based on wearable devices and Clinic rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 31 Mar 2028
- Phase
- Interventional
- 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 10 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1.Aged between 10 and 60 years.
- 2.Diagnosed with a discoid meniscus injury, confirmed by both magnetic resonance imaging (MRI) and arthroscopy.
- 3.Underwent arthroscopic partial meniscectomy (saucerization) with concomitant suture repair.
- 4.Willing to participate in the clinical trial and comply with the follow-up protocol.
Who cannot join
- 1.Presence of concomitant injuries in the same knee, such as ligament tears, fractures, or cartilage lesions.
- 2.Kellgren \& Lawrence osteoarthritis grade greater than II.
- 3.History of trauma or surgery in other weight-bearing joints of the lower limb (e.g., ankle ligament tears, osteonecrosis of the femoral head) that could indirectly affect knee joint loading and movement.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Application of Smart Wearable Device-Based Remote Rehabilitation in Postoperative Recovery After Arthroscopic Surgery for Discoid Meniscus: A Prospective, Randomized Controlled Trial Protocol
This study is designed as a single-center, prospective, randomized controlled trial. The aim of this clinical trial is to evaluate the effectiveness, safety, and feasibility of a wearable device-based telerehabilitation approach for postoperative recovery in patients undergoing arthroscopic surgery for discoid meniscus injury. The core research questions to be addressed are: to compare the effects of two postoperative rehabilitation methods (clinic rehabilitation versus telerehabilitation) on knee function scores in patients after arthroscopic discoid meniscus surgery; and to compare patient satisfaction, rehabilitation adherence, and clinical benefit between the two postoperative rehabilitation interventions. Participants will be randomly assigned to either the clinic rehabilitation group or the telerehabilitation group. The telerehabilitation group will undergo digital rehabilitation using wearable devices and a telerehabilitation system postoperatively, while the clinic rehabilitation group will receive one-on-one exercise rehabilitation sessions in an outpatient setting. Both groups will be followed up for six months postoperatively, with assessments scheduled at multiple time points: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively. The primary outcome measures focus on clinical functional improvement, including range of motion (ROM), weight-bearing progression, muscle strength, swelling, limb circumference, functional scores (Visual Analog Scale [VAS] for pain, Tegner activity scale, International Knee Documentation Committee [IKDC] subjective form, Lysholm knee score, Ikeuchi meniscus postoperative functional score), three-dimensional gait analysis parameters, and return-to-sports evaluation. Secondary outcomes include patient satisfaction, rehabilitation adherence, imaging findings, and complication assessment.
- Conditions
- Discoid Meniscus of Knee
- Being tested
- Telerehabilitation intervention based on wearable devices, Clinic rehabilitation
- Keywords
- telerehabilitation, wearable device, discoid meniscus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation intervention based on wearable devicesOther
This model integrated 5G network connectivity, mobile terminal applications, and wearable devices, enabling patients to perform rehabilitation exercises under real-time video and audio guidance. Patients underwent systematic telerehabilitation training assisted by wearable devices, following the same rehabilitation protocol as the on-site rehabilitation group. The patients installed the software on their smartphones and received a 24-week daily exercise program through the software platform. The rehabilitation training content for each phase was developed by a therapist on the software backend and then delivered to the patient via the application.
Clinic rehabilitationOther
Patients in the on-site rehabilitation group attended outpatient follow-up visits at 2, 6, 12, and 24 weeks postoperatively. During these visits, they received one-on-one, face-to-face systematic exercise rehabilitation training and guidance from a uniformly trained rehabilitation therapist, with at least one session per time point, each lasting 40 minutes. After mastering the essential techniques of the prescribed exercises, patients continued rehabilitation at home independently according to the established protocol.
| Study group | Role | What they receive |
|---|---|---|
| Clinic rehabilitation group | Active comparator | Postoperatively, patients received systematic on-site rehabilitation guidance from a therapist and were permitted to continue rehabilitation at home independently only after mastering the essential techniques of the prescribed exercises. Receives: Other: Clinic rehabilitation |
| Telerehabilitation group | Experimental | Postoperatively, patients underwent systematic telerehabilitation training assisted by smart wearable devices. Receives: Other: Telerehabilitation intervention based on wearable devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lysholm knee scoring scale
The full name of the scale is the Lysholm Knee Scoring Scale. The minimum possible score is 0, and the maximum is 100, with higher scores indicating better outcomes.
Measured: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.
Visual Analog Scale
The full name of the scale is Visual Analog Scale. The minimum possible score is 0, and the maximum is 10, with higher scores indicating worse outcomes.
Measured: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.
IKDC Subjective Knee Evaluation Form
The full name of the scale is IKDC Subjective Knee Evaluation Form. The minimum possible score is 0, and the maximum is 100, with higher scores indicating better outcomes.
Measured: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.
Tegner score
The full name of the scale is Tegner score The minimum possible score is 0, and the maximum is 10, with higher scores indicating better outcomes.
Measured: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.
Three-dimensional gait analysis
Three-dimensional gait analysis will use an infrared three-dimensional motion capture system to assess patient gait parameters, including step length (in meters), gait speed (in meters per second), gait cycle (in seconds), and other metrics.
Measured: preoperatively, and at 24 weeks postoperatively.
Knee range of motion
Knee range of motion refers to the measured angles of knee flexion and extension, expressed in degrees. The measurement method is as follows: using the lateral femoral epicondyle as the axis, the angle between the longitudinal axis of the femur and the long axis of the fibula is measured. The normal range is 0° to 150°.
Measured: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.
Limb Circumference
Limb circumference refers to the measurement of the cross-sectional dimension of the thigh, expressed in centimeters. The cross-sectional dimensions of the limb will be measured at 5 cm, 10 cm, and 15 cm proximal to the superior border of the patella.
Measured: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.
Muscle Strength
Muscle strength refers to the measurement of muscle strength using an isokinetic dynamometer, yielding the peak torque of the quadriceps and hamstring muscles, expressed in Nm/kg
Measured: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.
Return to Sport Assessment
Return-to-sport assessment refers to the decision-making process that systematically evaluates the readiness for safe return to sport using a multi-dimensional indicator system. This assessment includes the VAS score, muscle strength test results, single-leg hop test results (testing method: bilateral single-leg hops are performed separately, the hop distance is recorded in centimeters, and the interlimb difference is calculated as a percentage), and the Y-balance test (testing method: anterior, posteromedial, and posterolateral reaches are performed bilaterally, the foot displacement is recorded in centimeters, and both interlimb difference and symmetry index are calculated as percentages).
Measured: at 24 weeks postoperatively
Secondary outcomes (4)
MRI
MRI will utilize T1-weighted and T2-weighted images in the axial, coronal, and sagittal planes to describe the degree of injury and healing of the discoid meniscus, the extent of articular cartilage damage, etc.
Measured: preoperatively and at 24 weeks postoperatively.
Patient Satisfaction Questionnaire
Patient satisfaction questionnaire: Using a questionnaire format, patients report whether they are satisfied with their current overall recovery status. The proportion of patients selecting 'very satisfied' is then calculated and expressed as a percentage (%).
Measured: at 24 weeks postoperatively
Rehabilitation Adherence
Rehabilitation adherence will be calculated as the exercise completion rate recorded by the remote rehabilitation platform and the patient self-reported exercise completion rate, expressed as a percentage (%).
Measured: From preoperatively to 24 weeks postoperatively
X-ray
X-rays will be taken of the patient's knee joint in anteroposterior and lateral views, and the findings will describe whether the femur and tibia are fixed in proper alignment, the severity of knee osteoarthritis, etc.
Measured: preoperatively and at 24 weeks postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Discoid Meniscus of KneeStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deng Qian, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549867
- Sponsor's protocol ID
- 2026（399）
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Smart Wearable Device-Based Remote Rehabilitation in Postoperative Recovery After Arthroscopic Surgery for Discoid Meniscus: A Prospective, Randomized Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT07549867
- Acronym / sponsor ID
- 2026（399）
- Conditions
- Discoid Meniscus of Knee
- Keywords
- telerehabilitation, wearable device, discoid meniscus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 24 Apr 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 study is designed as a single-center, prospective, randomized controlled trial. The aim of this clinical trial is to evaluate the effectiveness, safety, and feasibility of a wearable device-based telerehabilitation approach for postoperative recovery in patients undergoing arthroscopic surgery for discoid meniscus injury. The core research questions to be addressed are: to compare the effects of two postoperative rehabilitation methods (clinic rehabilitation versus telerehabilitation) on knee function scores in patients after arthroscopic discoid meniscus surgery; and to compare patient satisfaction, rehabilitation adherence, and clinical benefit between the two postoperative rehabilitation interventions. Participants will be randomly assigned to either the clinic rehabilitation group or the telerehabilitation group. The telerehabilitation group will undergo digital rehabilitation using wearable devices and a telerehabilitation system postoperatively, while the clinic rehabilitation group will receive one-on-one exercise rehabilitation sessions in an outpatient setting. Both groups will be followed up for six months postoperatively, with assessments scheduled at multiple time points: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively. The primary outcome measures focus on clinical functional improvement, including range of motion (ROM), weight-bearing progression, muscle strength, swelling, limb circumference, functional scores (Visual Analog Scale [VAS] for pain, Tegner activity scale, International Knee Documentation Committee [IKDC] subjective form, Lysholm knee score, Ikeuchi meniscus postoperative functional score), three-dimensional gait analysis parameters, and return-to-sports evaluation. Secondary outcomes include patient satisfaction, rehabilitation adherence, imaging findings, and complication assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinic rehabilitation group | Active comparator | Other: Clinic rehabilitationPostoperatively, patients received systematic on-site rehabilitation guidance from a therapist and were permitted to continue rehabilitation at home independently only after mastering the essential techniques of the prescribed exercises. |
| Telerehabilitation group | Experimental | Other: Telerehabilitation intervention based on wearable devicesPostoperatively, patients underwent systematic telerehabilitation training assisted by smart wearable devices. |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 1.Aged between 10 and 60 years.
- 2.Diagnosed with a discoid meniscus injury, confirmed by both magnetic resonance imaging (MRI) and arthroscopy.
- 3.Underwent arthroscopic partial meniscectomy (saucerization) with concomitant suture repair.
- 4.Willing to participate in the clinical trial and comply with the follow-up protocol.
Key exclusion criteria (3 listed)
- 1.Presence of concomitant injuries in the same knee, such as ligament tears, fractures, or cartilage lesions.
- 2.Kellgren \& Lawrence osteoarthritis grade greater than II.
- 3.History of trauma or surgery in other weight-bearing joints of the lower limb (e.g., ankle ligament tears, osteonecrosis of the femoral head) that could indirectly affect knee joint loading and movement.
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 |
|---|---|---|
| Telerehabilitation intervention based on wearable devicesThis model integrated 5G network connectivity, mobile terminal applications, and wearable devices, enabling patients to perform rehabilitation exercises under real-time video and audio guidance. Patients underwent systematic telerehabilitation training assisted by wearable devices, following the same rehabilitation protocol as the on-site rehabilitation group. The patients installed the software on their smartphones and received a 24-week daily exercise program through the software platform. The rehabilitation training content for each phase was developed by a therapist on the software backend and then delivered to the patient via the application. | Other | Telerehabilitation group |
| Clinic rehabilitationPatients in the on-site rehabilitation group attended outpatient follow-up visits at 2, 6, 12, and 24 weeks postoperatively. During these visits, they received one-on-one, face-to-face systematic exercise rehabilitation training and guidance from a uniformly trained rehabilitation therapist, with at least one session per time point, each lasting 40 minutes. After mastering the essential techniques of the prescribed exercises, patients continued rehabilitation at home independently according to the established protocol. | Other | Clinic rehabilitation group |
Primary outcome
Lysholm knee scoring scale
Time frame: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.
The full name of the scale is the Lysholm Knee Scoring Scale. The minimum possible score is 0, and the maximum is 100, with higher scores indicating better outcomes.
Visual Analog Scale
Time frame: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.
The full name of the scale is Visual Analog Scale. The minimum possible score is 0, and the maximum is 10, with higher scores indicating worse outcomes.
IKDC Subjective Knee Evaluation Form
Time frame: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.
The full name of the scale is IKDC Subjective Knee Evaluation Form. The minimum possible score is 0, and the maximum is 100, with higher scores indicating better outcomes.
Tegner score
Time frame: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.
The full name of the scale is Tegner score The minimum possible score is 0, and the maximum is 10, with higher scores indicating better outcomes.
Three-dimensional gait analysis
Time frame: preoperatively, and at 24 weeks postoperatively.
Three-dimensional gait analysis will use an infrared three-dimensional motion capture system to assess patient gait parameters, including step length (in meters), gait speed (in meters per second), gait cycle (in seconds), and other metrics.
Knee range of motion
Time frame: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.
Knee range of motion refers to the measured angles of knee flexion and extension, expressed in degrees. The measurement method is as follows: using the lateral femoral epicondyle as the axis, the angle between the longitudinal axis of the femur and the long axis of the fibula is measured. The normal range is 0° to 150°.
Limb Circumference
Time frame: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.
Limb circumference refers to the measurement of the cross-sectional dimension of the thigh, expressed in centimeters. The cross-sectional dimensions of the limb will be measured at 5 cm, 10 cm, and 15 cm proximal to the superior border of the patella.
Muscle Strength
Time frame: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.
Muscle strength refers to the measurement of muscle strength using an isokinetic dynamometer, yielding the peak torque of the quadriceps and hamstring muscles, expressed in Nm/kg
Return to Sport Assessment
Time frame: at 24 weeks postoperatively
Return-to-sport assessment refers to the decision-making process that systematically evaluates the readiness for safe return to sport using a multi-dimensional indicator system. This assessment includes the VAS score, muscle strength test results, single-leg hop test results (testing method: bilateral single-leg hops are performed separately, the hop distance is recorded in centimeters, and the interlimb difference is calculated as a percentage), and the Y-balance test (testing method: anterior, posteromedial, and posterolateral reaches are performed bilaterally, the foot displacement is recorded in centimeters, and both interlimb difference and symmetry index are calculated as percentages).
4 secondary outcomes
MRI
Time frame: preoperatively and at 24 weeks postoperatively.
Patient Satisfaction Questionnaire
Time frame: at 24 weeks postoperatively
Rehabilitation Adherence
Time frame: From preoperatively to 24 weeks postoperatively
X-ray
Time frame: preoperatively and at 24 weeks 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 24 Apr 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation intervention based on wearable devices and Clinic rehabilitation in people with Discoid Meniscus of Knee, run by West China Hospital.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Qian Deng (+86 134-3807-6366, dengqianre@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lysholm knee scoring scale (time frame: preoperatively, and at 2 weeks, 6 weeks, 12 weeks, and 24 weeks postoperatively.). The study lists 9 primary outcomes in all. 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 24 Apr 2026.