NCT01571102

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 28, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 4, 2012

Completed
10 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

December 29, 2022

Status Verified

December 1, 2014

Enrollment Period

2.3 years

First QC Date

March 28, 2012

Last Update Submit

December 26, 2022

Conditions

Outcome Measures

Primary Outcomes (30)

  • Speed of resumption of work/ sports and daily activities.

    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.

    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.

    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.

    This outcome will be derived from the Tegner questionnaire.

    After 4 weeks post-operative

  • Speed of resumption of work/ sports and daily activities.

    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.

    This outcome will be derived from a physiotherapeutic questionnaire.

    After 4 weeks post-operative

  • Speed of resumption of work/ sports and daily activities.

    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.

    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.

    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.

    This outcome will be derived from the Tegner questionnaire.

    After 3 months post-operative

  • Speed of resumption of work/ sports and daily activities.

    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.

    This outcome will be derived from a physiotherapeutic questionnaire.

    After 3 months post-operative

  • Speed of resumption of work/ sports and daily activities.

    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.

    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.

    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.

    This outcome will be derived from the Tegner questionnaire.

    After 6 months post-operative

  • Speed of resumption of work/ sports and daily activities.

    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.

    This outcome will be derived from a physiotherapeutic questionnaire.

    After 6 months post-operative

  • Speed of resumption of work/ sports and daily activities.

    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.

    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.

    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.

    This outcome will be derived from the Tegner questionnaire.

    After 1 year post-operative

  • Speed of resumption of work/ sports and daily activities.

    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.

    This outcome will be derived from a physiotherapeutic questionnaire.

    After 1 year post-operative

  • Speed of resumption of work/ sports and daily activities.

    This outcome will be derived from the VAS (Visual analogue scales) questionnaire.

    Pre-operative

  • Speed of resumption of work/ sports and daily activities.

    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.

    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.

    This outcome will be derived from the Tegner questionnaire.

    Pre-operative

  • Speed of resumption of work/ sports and daily activities.

    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.

    This outcome will be derived from a physiotherapeutic questionnaire.

    Pre-operative

Secondary Outcomes (1)

  • The presence of a total number of complaints.

    pre-operative and 4 weeks, 3 months, 6 months and 1 year post-operative.

Study Arms (3)

physiotherapy

ACTIVE COMPARATOR

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

Rest

NO INTERVENTION

Home exercises

ACTIVE COMPARATOR

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

Interventions

TherapyBEHAVIORAL

week 1 - 4: 3 times/week, week 5 - 8: 2 times/week, duration 40min.

physiotherapy

week 1 - 4: 3 times/week, week 5 - 8: 2 times/week, duration 30 min.

Home exercises

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Post-operative meniscectomy and surgery at Ghent University Hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Interventions

TherapeuticsExercise Therapy

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CarePhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2012

First Posted

April 4, 2012

Study Start

February 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

December 29, 2022

Record last verified: 2014-12

Locations