Impact of Physiotherapy on Short-term Outcome After Meniscectomy

Meniscectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01571102
• Other study ID #: 2012/161
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: June 2015

Study information

• Verified date: December 2014
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Post-operative meniscectomy and surgery at Ghent University Hospital

Exclusion Criteria:

Related Conditions & MeSH terms

• Meniscectomy

Intervention

Behavioral:
• Therapy
week 1 - 4: 3 times/week, week 5 - 8: 2 times/week, duration 40min.
• Exercise therapy
week 1 - 4: 3 times/week, week 5 - 8: 2 times/week, duration 30 min.

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Speed of resumption of work/ sports and daily activities.	This outcome will be derived from the Tegner questionnaire.	After 4 weeks post-operative
Primary	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
Primary	Speed of resumption of work/ sports and daily activities.	This outcome will be derived from a physiotherapeutic questionnaire.	After 4 weeks post-operative
Primary	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
Primary	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
Primary	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
Primary	Speed of resumption of work/ sports and daily activities.	This outcome will be derived from the Tegner questionnaire.	After 3 months post-operative
Primary	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
Primary	Speed of resumption of work/ sports and daily activities.	This outcome will be derived from a physiotherapeutic questionnaire.	After 3 months post-operative
Primary	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
Primary	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
Primary	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
Primary	Speed of resumption of work/ sports and daily activities.	This outcome will be derived from the Tegner questionnaire.	After 6 months post-operative
Primary	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
Primary	Speed of resumption of work/ sports and daily activities.	This outcome will be derived from a physiotherapeutic questionnaire.	After 6 months post-operative
Primary	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
Primary	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
Primary	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
Primary	Speed of resumption of work/ sports and daily activities.	This outcome will be derived from the Tegner questionnaire.	After 1 year post-operative
Primary	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
Primary	Speed of resumption of work/ sports and daily activities.	This outcome will be derived from a physiotherapeutic questionnaire.	After 1 year post-operative
Primary	Speed of resumption of work/ sports and daily activities.	This outcome will be derived from the VAS (Visual analogue scales) questionnaire.	Pre-operative
Primary	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
Primary	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
Primary	Speed of resumption of work/ sports and daily activities.	This outcome will be derived from the Tegner questionnaire.	Pre-operative
Primary	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
Primary	Speed of resumption of work/ sports and daily activities.	This outcome will be derived from a physiotherapeutic questionnaire.	Pre-operative
Secondary	The presence of a total number of complaints.	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.

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