Partial MeniscectomyNI-RCTNCT07358325
Video-Based Education Versus In-Person Education in Patients Undergoing Arthroscopic Partial Meniscectomy
A study testing Video-based education in people with Partial Meniscectomy and Knee Arthroscopic Surgery, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
The primary aim of the study is to investigate whether video-based education and exercise-program is non-inferior to in-person instructions in improving pain-related self-efficacy in patients undergoing arthroscopic partial meniscectomy in a day-hospital setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial Meniscectomy, Knee Arthroscopic Surgery
- What is being tested?
- Video-based education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteItaly
- Study dates
- 19 Jan 2026to Jun 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for arthroscopic partial meniscectomy (medial or lateral meniscus) performed in a day-hospital setting.
- Traumatic or degenerative meniscal tears.
- Treatment at the Hip and Knee Orthopedic Unit of the Humanitas Clinical Institute.
- Age ≥ 18 years.
- Access to adequate video support.
- Sufficient proficiency in the Italian language.
Who cannot join
- Previous surgery on either knee within the past 5 years.
- Significant postoperative hematoma requiring aspiration.
- Neurological conditions potentially affecting functional or motor recovery.
- Musculoskeletal conditions potentially affecting functional or motor recovery.
- Rheumatologic conditions potentially affecting functional or motor recovery.
- Internal medicine conditions potentially affecting functional or motor recovery.
- Oncological conditions potentially affecting functional or motor recovery.
- Cognitive or psychiatric disorders (Mini-Mental State Examination ≤ 21).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089
Roberto Gatti, +390282245610, roberto.gatti@hunimed.eu
About this study
Official title: Effectiveness of a Video-Based Educational Intervention Compared With In-Person Education on Psychosocial and Functional Outcomes in Patients Undergoing Arthroscopic Partial Meniscectomy: A Noninferiority Randomized Controlled Trial
The primary aim of the study is to investigate whether video-based education and exercise-program is non-inferior to in-person instructions in improving pain-related self-efficacy in patients undergoing arthroscopic partial meniscectomy in a day-hospital setting. Secondary aims are to explore the potential superiority of the video-based program compared to in-person instructions in reducing disability and kinesiophobia in the same patient population.
- Conditions
- Partial Meniscectomy, Knee Arthroscopic Surgery
- Being tested
- Video-based education, Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-based educationBehavioural
The video-based education was sent to patients within 5-day before surgery and consists of instructions to follow after surgery on wight-baring on the operated limb, advice to reduce swelling and movements tallowed to be performed. Exercises to perform in the 2 weeks after surgery are shown.
Usual CareBehavioural
Immediately after the surgery in day-hospital setting, a physiotherapist provided in-person instructions to patients assigned to control group. Instructions consists of the same educational content of the video-based group and the same exercises to perform in 2-weeks after surgery are shown and provided on a written spreadsheet.
| Study group | Role | What they receive |
|---|---|---|
| Video-based group | Experimental | Subjects assigned to this group will be asked to watch educational video within 5 days before surgery and to performe exercises shown in the video during the 2 weeks after surgery. Receives: Behavioral: Video-based education |
| Control group | Active comparator | Subjects assigned to this group will be instructed in-person by a physiotherapist on educational advice and exercises to perform during the 2 weeks after surgery. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Self-Efficacy Questionnaire (PSEQ)
The PSEQ assesses patients' confidence in performing daily activities despite pain, with score ranging from 0 to 60 and higher scores indicating greater pain-related self-efficacy.
Measured: From enrolment to the 6 weeks after surgery
Secondary outcomes (5)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The WOMAC evaluates knee pain, stiffness, and physical function, with score ranging from 0 to 96 and higher scores reflecting greater pain and functional impairment.
Measured: From enrolment to the 3 weeks after surgery
Tampa Scale of Kinesiophobia (TSK)
The TSK measures fear of movement and re-injury related to pain, with score ranging from 17 to 68 and higher scores indicating greater levels of kinesiophobia.
Measured: From enrolment to the 3 weeks after surgery
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The WOMAC evaluates knee pain, stiffness, and physical function, with score ranging from 0 to 96 and higher scores reflecting greater pain and functional impairment.
Measured: From enrolment to the 6 weeks after surgery
Tampa Scale of Kinesiophobia (TSK)
The TSK measures fear of movement and re-injury related to pain, with score ranging from 17 to 68 and higher scores indicating greater levels of kinesiophobia.
Measured: From enrolment to the 6 weeks after surgery
Pain Self-Efficacy Questionnaire (PSEQ)
The PSEQ assesses patients' confidence in performing daily activities despite pain, with score ranging from 0 to 60 and higher scores indicating greater pain-related self-efficacy.
Measured: From enrolment to the 3 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start19 Jan 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial MeniscectomyStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358325
- Sponsor's protocol ID
- CLF23/05
- Acronym
- NI-RCT
- Status last verified
- Feb 2026
- First submitted
- 13 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets analyzed in this study are available on request from the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Video-Based Educational Intervention Compared With In-Person Education on Psychosocial and Functional Outcomes in Patients Undergoing Arthroscopic Partial Meniscectomy: A Noninferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07358325
- Acronym / sponsor ID
- NI-RCT / CLF23/05
- Conditions
- Partial Meniscectomy, Knee Arthroscopic Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 19 Jan 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 22 Jan 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.
The primary aim of the study is to investigate whether video-based education and exercise-program is non-inferior to in-person instructions in improving pain-related self-efficacy in patients undergoing arthroscopic partial meniscectomy in a day-hospital setting. Secondary aims are to explore the potential superiority of the video-based program compared to in-person instructions in reducing disability and kinesiophobia in the same patient population.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video-based group | Experimental | Behavioral: Video-based educationSubjects assigned to this group will be asked to watch educational video within 5 days before surgery and to performe exercises shown in the video during the 2 weeks after surgery. |
| Control group | Active comparator | Behavioral: Usual CareSubjects assigned to this group will be instructed in-person by a physiotherapist on educational advice and exercises to perform during the 2 weeks after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients scheduled for arthroscopic partial meniscectomy (medial or lateral meniscus) performed in a day-hospital setting.
- Traumatic or degenerative meniscal tears.
- Treatment at the Hip and Knee Orthopedic Unit of the Humanitas Clinical Institute.
- Age ≥ 18 years.
- Access to adequate video support.
Key exclusion criteria (8 listed)
- Previous surgery on either knee within the past 5 years.
- Significant postoperative hematoma requiring aspiration.
- Neurological conditions potentially affecting functional or motor recovery.
- Musculoskeletal conditions potentially affecting functional or motor recovery.
- Rheumatologic conditions potentially affecting functional or motor recovery.
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 |
|---|---|---|
| Video-based educationThe video-based education was sent to patients within 5-day before surgery and consists of instructions to follow after surgery on wight-baring on the operated limb, advice to reduce swelling and movements tallowed to be performed. Exercises to perform in the 2 weeks after surgery are shown. | Behavioural | Video-based group |
| Usual CareImmediately after the surgery in day-hospital setting, a physiotherapist provided in-person instructions to patients assigned to control group. Instructions consists of the same educational content of the video-based group and the same exercises to perform in 2-weeks after surgery are shown and provided on a written spreadsheet. | Behavioural | Control group |
Primary outcome
Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: From enrolment to the 6 weeks after surgery
The PSEQ assesses patients' confidence in performing daily activities despite pain, with score ranging from 0 to 60 and higher scores indicating greater pain-related self-efficacy.
5 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: From enrolment to the 3 weeks after surgery
Tampa Scale of Kinesiophobia (TSK)
Time frame: From enrolment to the 3 weeks after surgery
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: From enrolment to the 6 weeks after surgery
Tampa Scale of Kinesiophobia (TSK)
Time frame: From enrolment to the 6 weeks after surgery
Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: From enrolment to the 3 weeks after surgery
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 5 Feb 2026.
- Individual participant dataSharing planned: Yes. The datasets analyzed in this study are available on request from the corresponding author.
Related trials for Partial Meniscectomy
RecruitingObservational study
Assessment of the Degree of Regeneration After Partial Meniscectomy Based on Thin-layer MRI Image Segmentation and Reconstruction
Meniscus Regeneration, Partial Meniscectomy
Active, not recruitingPhase 4
Corticosteroid Meniscectomy Randomized Trial
Osteoarthritis, Knee, Meniscus Tear
RecruitingObservational study
Surgical Outcome After Displaced Bucket-handle Meniscal Lesions - Repair Versus Partial Meniscectomy
Meniscus Rupture, Meniscus Injury
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-based education in people with Partial Meniscectomy and Knee Arthroscopic Surgery, run by Istituto Clinico Humanitas at 1 site in Italy.
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 6 inclusion and 8 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 5 Feb 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 Italy. 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 Roberto Gatti (+390282245610, roberto.gatti@hunimed.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Self-Efficacy Questionnaire (PSEQ) (time frame: From enrolment to the 6 weeks after surgery). 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 5 Feb 2026.