Impact of Physiotherapy on Short-term Outcome After Meniscectomy

December 26, 2022 updated by: University Hospital, Ghent

Study of Impact of Physiotherapy on Short-term Outcome After Meniscectomy.

In this study we investigate whether physiotherapy offers added value in rehabilitation after meniscectomy compared with no therapy or a home program. The population consists of 180 post-operative meniscus injury patients, operated at UZ Gent, the first 60 patients received no therapy, the next 60 patients were offered a treatment by their home physiotherapist according to our established protocol and the last 60 patients we have prepared a home program .

The physiotherapeutic treatment has been prepared based on scientific literature and own experience from the program at Ghent University and internships. It includes exercises to promote mobility, strength and stability and exercises to reduce pain and swelling depending on the phase of tissue repair and evolution of the patient. This schedule will be given to the patient along with the questionnaires at registration of the operation and will serve as a guideline for the physiotherapist for the rehabilitation of the patient after surgery. Monitoring of the evolution will take place by calling the physiotherapist on regular basis.

The home program is prepared on the basis of commonly used home exercises after arthroscopy and also includes exercises to promote mobility, strength and stability and exercises to reduce pain and swelling. The difference with the physiotherapeutic treatment is that there is no control and supervision of a physiotherapist and that the treatment is more limited. This program is given with the patient along with the questionnaires at registration of the operation.

Pre-operatively and 4 weeks, 3 months, 6 months and 12 months post-operatively, an evaluation of the current condition of the patient will happen on the basis of standardized questionnaires. Based on the results of these questionnaires, collected at different times, we can determine which treatment provides the best rehabilitation after meniscectomy. The first (preoperative) questionnaire, given at registration of the operation, is completed and given to the nurse of the day hospital on the day of surgery, the other (postoperative) questionnaires are sent electronically to the patient's email address and need to be returned, after filling up.

This study spends specific attention to the speed of resumption of work / sports and daily activities and the presence or absence of complaints.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Ghent University Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Post-operative meniscectomy and surgery at Ghent University Hospital

Exclusion Criteria:

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Rest
Active Comparator: physiotherapy
Promote mobility, strength and stability and exercises to reduce pain and swelling depending on the phase of tissue repair and evolution of the patient.
Behavioral: Therapy
week 1 - 4: 3 times/week, week 5 - 8: 2 times/week, duration 40min.
Active Comparator: Home exercises
Promote mobility, strength and stability and exercises to reduce pain and swelling depending on the phase of tissue repair and evolution of the patient.
Behavioral: Exercise therapy
week 1 - 4: 3 times/week, week 5 - 8: 2 times/week, duration 30 min.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Speed of resumption of work/ sports and daily activities.
Time Frame: After 4 weeks post-operative
This outcome will be derived from the VAS (Visual analogue scales) questionnaire.
After 4 weeks post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 4 weeks post-operative
This outcome will be derived from the KOOS (Knee injury and Osteoarthritis Outcome Score)questionnaire.
After 4 weeks post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 4 weeks post-operative
This outcome will be derived from the SF-36 (Short Form Health Survey 36) questionnaire.
After 4 weeks post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 4 weeks post-operative
This outcome will be derived from the Tegner questionnaire.
After 4 weeks post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 4 weeks post-operative
This outcome will be derived from the FORSS (Factor Occupational Rating System Scale)questionnaire.
After 4 weeks post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 4 weeks post-operative
This outcome will be derived from a physiotherapeutic questionnaire.
After 4 weeks post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 3 months post-operative
This outcome will be derived from the VAS (Visual analogue scales) questionnaire.
After 3 months post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 3 months post-operative
This outcome will be derived from the KOOS (Knee injury and Osteoarthritis Outcome Score)questionnaire.
After 3 months post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 3 months post-operative
This outcome will be derived from the SF-36 (Short Form Health Survey 36) questionnaire.
After 3 months post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 3 months post-operative
This outcome will be derived from the Tegner questionnaire.
After 3 months post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 3 months post-operative
This outcome will be derived from the FORSS (Factor Occupational Rating System Scale)questionnaire.
After 3 months post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 3 months post-operative
This outcome will be derived from a physiotherapeutic questionnaire.
After 3 months post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 6 months post-operative
This outcome will be derived from the VAS (Visual analogue scales) questionnaire.
After 6 months post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 6 months post-operative
This outcome will be derived from the KOOS (Knee injury and Osteoarthritis Outcome Score)questionnaire.
After 6 months post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 6 months post-operative
This outcome will be derived from the SF-36 (Short Form Health Survey 36) questionnaire.
After 6 months post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 6 months post-operative
This outcome will be derived from the Tegner questionnaire.
After 6 months post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 6 months post-operative
This outcome will be derived from the FORSS (Factor Occupational Rating System Scale)questionnaire.
After 6 months post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 6 months post-operative
This outcome will be derived from a physiotherapeutic questionnaire.
After 6 months post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 1 year post-operative
This outcome will be derived from the VAS (Visual analogue scales) questionnaire.
After 1 year post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 1 year post-operative
This outcome will be derived from the KOOS (Knee injury and Osteoarthritis Outcome Score)questionnaire.
After 1 year post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 1 year post-operative
This outcome will be derived from the SF-36 (Short Form Health Survey 36) questionnaire.
After 1 year post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 1 year post-operative
This outcome will be derived from the Tegner questionnaire.
After 1 year post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 1 year post-operative
This outcome will be derived from the FORSS (Factor Occupational Rating System Scale)questionnaire.
After 1 year post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: After 1 year post-operative
This outcome will be derived from a physiotherapeutic questionnaire.
After 1 year post-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: Pre-operative
This outcome will be derived from the VAS (Visual analogue scales) questionnaire.
Pre-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: Pre-operative
This outcome will be derived from the KOOS (Knee injury and Osteoarthritis Outcome Score)questionnaire.
Pre-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: Pre-operative
This outcome will be derived from the SF-36 (Short Form Health Survey 36) questionnaire.
Pre-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: Pre-operative
This outcome will be derived from the Tegner questionnaire.
Pre-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: Pre-operative
This outcome will be derived from the FORSS (Factor Occupational Rating System Scale)questionnaire.
Pre-operative
Speed of resumption of work/ sports and daily activities.
Time Frame: Pre-operative
This outcome will be derived from a physiotherapeutic questionnaire.
Pre-operative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The presence of a total number of complaints.
Time Frame: pre-operative and 4 weeks, 3 months, 6 months and 1 year post-operative.
This outcome will be derived from questionnaires: VAS, KOOS, SF-36, TEGNER, FORSS, physiotherapeutic questionnaire
pre-operative and 4 weeks, 3 months, 6 months and 1 year post-operative.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2012/161

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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