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NCT Number: NCT06920394

Functionality of Lower Limbs in Patients Who Have Undergone Knee Meniscectomy

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).

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Key information

Conditions

Meniscectomy Sequelae Anxiety Disorders Kinesiophobia Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Phobic Disorders Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universidad Católica San Antonio de Murcia

Murcia, Principality of Asturias, 33006, Spain

Location contact

Rubén Cuesta-Barriuso, PhD

CONTACT

[email protected]

0034 985 103 386

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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)

  2. Assessment of the patient's weight at the time of the study

    Time frame: Screening visit

    The anthropometric variables of weight (measured in kg)

  3. 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

  4. Assessment of the patient's height at the time of the study

    Time frame: Screening visit

    The anthropometric variable height (measured in cm)

  5. 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

  6. 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.

  7. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Rubén Cuesta-Barriuso, PhD

CONTACT

[email protected]

0034 985103386

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study title

Functionality of Lower Limbs in Patients Who Have Undergone Knee Meniscectomy. A Multicenter Ambispective Cohort Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 9, 2025
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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