NCT06920394

Brief 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. 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

April 5, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 9, 2025

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2025

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2025

Completed
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

23 days

First QC Date

April 1, 2025

Last Update Submit

April 7, 2025

Conditions

Keywords

Knee meniscectomyFunctionalityRange of movementPain intensityKinesiophobia

Outcome Measures

Primary Outcomes (1)

  • 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.

    Screening visit

Secondary Outcomes (3)

  • Assessment of range of knee motion

    Screening visit

  • Assessment of pain perception

    Screening visit

  • Assessment of Kinesiophobia

    Screening visit

Other Outcomes (7)

  • Assessment of the time elapsed since the surgical intervention

    Screening visit

  • Assessment of the patient's weight at the time of the study

    Screening visit

  • Measurement of the patient's age at the time of the study

    Screening visit

  • +4 more other outcomes

Study Arms (1)

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.

Other: Survey using a questionnaire.

Interventions

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

Observational group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People with previous meniscectomy surgery

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Católica San Antonio de Murcia

Murcia, Principality of Asturias, 33006, Spain

Location

MeSH Terms

Conditions

PainKinesiophobia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPhobic DisordersAnxiety DisordersMental Disorders

Central Study Contacts

Rubén Cuesta-Barriuso, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 1, 2025

First Posted

April 9, 2025

Study Start

April 5, 2025

Primary Completion

April 28, 2025

Study Completion

May 20, 2025

Last Updated

April 9, 2025

Record last verified: 2025-04

Locations