Functionality of Lower Limbs in Patients Who Have Undergone Knee Meniscectomy

April 7, 2025 updated by: Rubén Cuesta-Barriuso, PhD, Universidad Católica San Antonio de Murcia

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

Not yet recruiting

Study Type

Observational

Enrollment (Estimated)

89

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Asturias
      • Murcia, Asturias, Spain, 33006
        • Universidad Católica San Antonio de Murcia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

People with previous meniscectomy surgery

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
In the present study, no intervention will be carried out, and only the patients recruited will complete the questionnaires set out below.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Screening visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of range of knee motion
Time Frame: Screening visit
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.
Screening visit
Assessment of pain perception
Time Frame: Screening visit
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.
Screening visit
Assessment of Kinesiophobia
Time Frame: Screening visit
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.
Screening visit

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the time elapsed since the surgical intervention
Time Frame: Screening visit
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)
Screening visit
Assessment of the patient's weight at the time of the study
Time Frame: Screening visit
The anthropometric variables of weight (measured in kg)
Screening visit
Measurement of the patient's age at the time of the study
Time Frame: Screening visit
The sociodemographic variables age (in whole months) will be measured
Screening visit
Assessment of the patient's height at the time of the study
Time Frame: Screening visit
The anthropometric variable height (measured in cm)
Screening visit
Assessment of the patient's gender at the time of the study
Time Frame: Screening visit
The sociodemographic variable gender (male/female) will be measured
Screening visit
Assessment of the patient's type of work at the time of the study
Time Frame: Screening visit
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.
Screening visit
Measurement of the patient's level of physical activity before and after surgery
Time Frame: Screening visit
The variable physical exercise before and after meniscectomy will be measured (dichotomous answers: yes/no).
Screening visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 5, 2025

Primary Completion (Estimated)

April 28, 2025

Study Completion (Estimated)

May 20, 2025

Study Registration Dates

First Submitted

April 1, 2025

First Submitted That Met QC Criteria

April 7, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

April 1, 2025

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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