- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06920394
Functionality of Lower Limbs in Patients Who Have Undergone Knee Meniscectomy
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Rubén Cuesta-Barriuso, PhD
- Phone Number: 0034 985103386
- Email: ruben.cuestab@gmail.com
Study Locations
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Asturias
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Murcia, Asturias, Spain, 33006
- Universidad Católica San Antonio de Murcia
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Contact:
- Rubén Cuesta-Barriuso, PhD
- Phone Number: 0034 985 103 386
- Email: ruben.cuestab@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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In the present study, no intervention will be carried out, and only the patients recruited will complete the questionnaires set out below.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of knee functionality
Time Frame: Screening visit
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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.
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Screening visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of range of knee motion
Time Frame: Screening visit
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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.
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Screening visit
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Assessment of pain perception
Time Frame: Screening visit
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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.
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Screening visit
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Assessment of Kinesiophobia
Time Frame: Screening visit
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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.
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Screening visit
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment of the time elapsed since the surgical intervention
Time Frame: Screening visit
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The main clinical variables will be measured: date of the surgical procedure and date of evaluation (in DD/MM/YYYY format; to calculate the elapsed time, in days)
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Screening visit
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Assessment of the patient's weight at the time of the study
Time Frame: Screening visit
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The anthropometric variables of weight (measured in kg)
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Screening visit
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Measurement of the patient's age at the time of the study
Time Frame: Screening visit
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The sociodemographic variables age (in whole months) will be measured
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Screening visit
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Assessment of the patient's height at the time of the study
Time Frame: Screening visit
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The anthropometric variable height (measured in cm)
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Screening visit
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Assessment of the patient's gender at the time of the study
Time Frame: Screening visit
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The sociodemographic variable gender (male/female) will be measured
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Screening visit
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Assessment of the patient's type of work at the time of the study
Time Frame: Screening visit
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The sociodemographic variable type of work (sedentary/active) will be measured.
This evaluation will be based on whether the work is office work or at least 4 hours/day sitting.
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Screening visit
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Measurement of the patient's level of physical activity before and after surgery
Time Frame: Screening visit
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The variable physical exercise before and after meniscectomy will be measured (dichotomous answers: yes/no).
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Screening visit
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Collaborators and Investigators
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
- FunctMenisc
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.
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