Meniscectomy SequelaeNCT06920394
Functionality of Lower Limbs in Patients Who Have Undergone Knee Meniscectomy
An observational study of Meniscectomy Sequelae, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
Introduction. Meniscal lesions are common and are associated with the development of osteoarthritis of the knee. Work activities that cause mechanical stress can lead to acute or chronic injuries. The surgical treatment for this injury is meniscectomy. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Meniscectomy Sequelae
- What is being tested?
- Survey using a questionnaire.
- How many people
- 89 participants
- Where
- 1 siteSpain
- Study dates
- 5 Apr 2025to 20 May 2025
- How long will I take part?
- 1 Day
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with previous meniscectomy surgery
Who may be able to join
- Persons aged 20 to 65
- Of both sexes
- With previous meniscectomy surgery in one of the two knees in the last 5 years
- Who sign the informed consent document.
Who cannot join
- Patients who require technical aids for walking
- Dependent patients for carrying out activities of daily living
- Patients over 65 years of age
- Patients with cognitive impairments that prevent understanding of tests and evaluations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Universidad Católica San Antonio de Murcia
Murcia, Principality of Asturias, 33006
Rubén Cuesta-Barriuso, PhD, 0034 985 103 386, ruben.cuestab@gmail.com
About this study
Official title: Functionality of Lower Limbs in Patients Who Have Undergone Knee Meniscectomy. A Multicenter Ambispective Cohort Study
Introduction. Meniscal lesions are common and are associated with the development of osteoarthritis of the knee. Work activities that cause mechanical stress can lead to acute or chronic injuries. The surgical treatment for this injury is meniscectomy. Physiotherapy is a widely accepted first-line treatment for patients with meniscus tears.
Objective. To assess the clinical and functional status of patients who have undergone meniscus surgery with and without post-surgical physiotherapy.
Material and method. Multicenter ambispective cohort study. 89 patients who have undergone meniscectomy will be recruited. The primary variable of the study will be functionality (Time Up \& Go), with the prescription of a post-surgical physiotherapy treatment being the dependent variable. The secondary variables, estimated as modifying or confounding, will be range of motion (goniometry), pain intensity (visual analog scale) and kinesiophobia (Tampa scale).
- Conditions
- Meniscectomy Sequelae
- Being tested
- Survey using a questionnaire.
- Keywords
- Knee meniscectomy, Functionality, Range of movement, Pain intensity, Kinesiophobia
- Medical subject headings
- Pain, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey using a questionnaire.Other
In the present study, no intervention will be carried out, and only the patients recruited will complete the questionnaires set out below.
| Study group | Role | What they receive |
|---|---|---|
| Observational group | Patients will be recruited from the Fisiomaturana and Fisialty centers. The primary variable of the study will be functionality, with the prescription of a post-surgical physiotherapy treatment being the dependent variable. The secondary variables, estimated as modifying or confounding, will be range of motion, pain intensity and kinesiophobia. Receives: Other: Survey using a questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of knee functionality
To assess knee functionality we will use the Time Up \& Go instrument. This test consists of getting up from a chair, walking three meters around an obstacle and returning to the starting position. This tool is closely related to the risk of falls. The unit of measurement is time, where the lower the mark, the better the functionality.
Measured: Screening visit
Secondary outcomes (3)
Assessment of range of knee motion
The range of knee motion will be assessed using a goniometer. The fixed arm will be placed between the center of the greater trochanter and the lateral epicondyle of the femur, while the movable arm will be placed on the axis of the tibia between the lateral femoral epicondyle and the center of the lateral malleolus. During the evaluation, each patient will be asked to perform maximum active knee flexion and extension. The unit of measurement is the maximum range of motion measured in degrees, where the higher the graduation, the greater the range of motion.
Measured: Screening visit
Assessment of pain perception
Pain perception will be measured using a visual analog scale. This measuring instrument quantifies pain according to the patient's subjective perception on a scale of 0 to 10, where 0 indicates the absence of pain and 10 the maximum pain perceived by the patient.
Measured: Screening visit
Assessment of Kinesiophobia
Kinesiophobia (fear of movement) will be measured using the Tampa Scale (TSK-11). This scale consists of 11 questions scored from 1 "strongly disagree" to 4 "strongly agree". The range of scores is from 11 to 44 points, where a higher score indicates greater fear of movement on the part of the respondent.
Measured: Screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start5 Apr 2025 (estimated)
- Primary completion28 Apr 2025 (estimated)
- Study completion20 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscectomy SequelaeStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 89 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubén Cuesta-Barriuso, PhD, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920394
- Sponsor's protocol ID
- FunctMenisc
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functionality of Lower Limbs in Patients Who Have Undergone Knee Meniscectomy. A Multicenter Ambispective Cohort Study
- ClinicalTrials.gov ID
- NCT06920394
- Acronym / sponsor ID
- FunctMenisc
- Conditions
- Meniscectomy Sequelae
- Keywords
- Knee meniscectomy, Functionality, Range of movement, Pain intensity, Kinesiophobia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 89 participants (estimated)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 5 Apr 2025 (estimated)
- Primary completion
- 28 Apr 2025 (estimated)
- Study completion
- 20 May 2025 (estimated)
- First posted
- 9 Apr 2025 (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.
Introduction. Meniscal lesions are common and are associated with the development of osteoarthritis of the knee. Work activities that cause mechanical stress can lead to acute or chronic injuries. The surgical treatment for this injury is meniscectomy. Physiotherapy is a widely accepted first-line treatment for patients with meniscus tears.
Objective. To assess the clinical and functional status of patients who have undergone meniscus surgery with and without post-surgical physiotherapy.
Material and method. Multicenter ambispective cohort study. 89 patients who have undergone meniscectomy will be recruited. The primary variable of the study will be functionality (Time Up \& Go), with the prescription of a post-surgical physiotherapy treatment being the dependent variable. The secondary variables, estimated as modifying or confounding, will be range of motion (goniometry), pain intensity (visual analog scale) and kinesiophobia (Tampa scale).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group | – | Other: Survey using a questionnaire.Patients will be recruited from the Fisiomaturana and Fisialty centers. The primary variable of the study will be functionality, with the prescription of a post-surgical physiotherapy treatment being the dependent variable. The secondary variables, estimated as modifying or confounding, will be range of motion, pain intensity and kinesiophobia. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with previous meniscectomy surgery
Key inclusion criteria (4 listed)
- Persons aged 20 to 65
- Of both sexes
- With previous meniscectomy surgery in one of the two knees in the last 5 years
- Who sign the informed consent document.
Key exclusion criteria (4 listed)
- Patients who require technical aids for walking
- Dependent patients for carrying out activities of daily living
- Patients over 65 years of age
- Patients with cognitive impairments that prevent understanding of tests and evaluations
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 |
|---|---|---|
| Survey using a questionnaire.In the present study, no intervention will be carried out, and only the patients recruited will complete the questionnaires set out below. | Other | Observational group |
Primary outcome
Assessment of knee functionality
Time frame: Screening visit
To assess knee functionality we will use the Time Up \& Go instrument. This test consists of getting up from a chair, walking three meters around an obstacle and returning to the starting position. This tool is closely related to the risk of falls. The unit of measurement is time, where the lower the mark, the better the functionality.
3 secondary outcomes
Assessment of range of knee motion
Time frame: Screening visit
Assessment of pain perception
Time frame: Screening visit
Assessment of Kinesiophobia
Time frame: Screening visit
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 9 Apr 2025.
- Individual participant dataSharing planned: Undecided
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?
An observational study of Meniscectomy Sequelae, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
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 4 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 9 Apr 2025. 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 Spain. 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 Rubén Cuesta-Barriuso, PhD (0034 985103386, ruben.cuestab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of knee functionality (time frame: Screening visit). 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 9 Apr 2025.