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Impact of Physiotherapy on Short-term Outcome After Meniscectomy

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01571102
First received: March 28, 2012
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Meniscectomy
Behavioral: Therapy
Behavioral: Exercise therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Impact of Physiotherapy on Short-term Outcome After Meniscectomy.

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Speed of resumption of work/ sports and daily activities. [ Time Frame: After 4 weeks post-operative ] [ Designated as safety issue: No ]
    This outcome will be derived from the VAS (Visual analogue scales) questionnaire.

  • Speed of resumption of work/ sports and daily activities. [ Time Frame: After 4 weeks post-operative ] [ Designated as safety issue: No ]
    This outcome will be derived from the KOOS (Knee injury and Osteoarthritis Outcome Score)questionnaire.

  • Speed of resumption of work/ sports and daily activities. [ Time Frame: After 4 weeks post-operative ] [ Designated as safety issue: No ]
    This outcome will be derived from the SF-36 (Short Form Health Survey 36) questionnaire.

  • Speed of resumption of work/ sports and daily activities. [ Time Frame: After 4 weeks post-operative ] [ Designated as safety issue: No ]
    This outcome will be derived from the Tegner questionnaire.

  • Speed of resumption of work/ sports and daily activities. [ Time Frame: After 4 weeks post-operative ] [ Designated as safety issue: No ]
    This outcome will be derived from the FORSS (Factor Occupational Rating System Scale)questionnaire.

  • Speed of resumption of work/ sports and daily activities. [ Time Frame: After 4 weeks post-operative ] [ Designated as safety issue: No ]
    This outcome will be derived from a physiotherapeutic questionnaire.

  • Speed of resumption of work/ sports and daily activities. [ Time Frame: After 3 months post-operative ] [ Designated as safety issue: No ]
    This outcome will be derived from the VAS (Visual analogue scales) questionnaire.

  • Speed of resumption of work/ sports and daily activities. [ Time Frame: After 3 months post-operative ] [ Designated as safety issue: No ]
    This outcome will be derived from the KOOS (Knee injury and Osteoarthritis Outcome Score)questionnaire.

  • Speed of resumption of work/ sports and daily activities. [ Time Frame: After 3 months post-operative ] [ Designated as safety issue: No ]
    This outcome will be derived from the SF-36 (Short Form Health Survey 36) questionnaire.

  • Speed of resumption of work/ sports and daily activities. [ Time Frame: After 3 months post-operative ] [ Designated as safety issue: No ]
    This outcome will be derived from the Tegner questionnaire.

  • Speed of resumption of work/ sports and daily activities. [ Time Frame: After 3 months post-operative ] [ Designated as safety issue: No ]
    This outcome will be derived from the FORSS (Factor Occupational Rating System Scale)questionnaire.

  • Speed of resumption of work/ sports and daily activities. [ Time Frame: After 3 months post-operative ] [ Designated as safety issue: No ]
    This outcome will be derived from a physiotherapeutic questionnaire.

  • Speed of resumption of work/ sports and daily activities. [ Time Frame: After 6 months post-operative ] [ Designated as safety issue: No ]
    This outcome will be derived from the VAS (Visual analogue scales) questionnaire.

  • Speed of resumption of work/ sports and daily activities. [ Time Frame: After 6 months post-operative ] [ Designated as safety issue: No ]
    This outcome will be derived from the KOOS (Knee injury and Osteoarthritis Outcome Score)questionnaire.

  • Speed of resumption of work/ sports and daily activities. [ Time Frame: After 6 months post-operative ] [ Designated as safety issue: No ]
    This outcome will be derived from the SF-36 (Short Form Health Survey 36) questionnaire.

  • Speed of resumption of work/ sports and daily activities. [ Time Frame: After 6 months post-operative ] [ Designated as safety issue: No ]
    This outcome will be derived from the Tegner questionnaire.

  • Speed of resumption of work/ sports and daily activities. [ Time Frame: After 6 months post-operative ] [ Designated as safety issue: No ]
    This outcome will be derived from the FORSS (Factor Occupational Rating System Scale)questionnaire.

  • Speed of resumption of work/ sports and daily activities. [ Time Frame: After 6 months post-operative ] [ Designated as safety issue: No ]
    This outcome will be derived from a physiotherapeutic questionnaire.

  • Speed of resumption of work/ sports and daily activities. [ Time Frame: After 1 year post-operative ] [ Designated as safety issue: No ]
    This outcome will be derived from the VAS (Visual analogue scales) questionnaire.

  • Speed of resumption of work/ sports and daily activities. [ Time Frame: After 1 year post-operative ] [ Designated as safety issue: No ]
    This outcome will be derived from the KOOS (Knee injury and Osteoarthritis Outcome Score)questionnaire.

  • Speed of resumption of work/ sports and daily activities. [ Time Frame: After 1 year post-operative ] [ Designated as safety issue: No ]
    This outcome will be derived from the SF-36 (Short Form Health Survey 36) questionnaire.

  • Speed of resumption of work/ sports and daily activities. [ Time Frame: After 1 year post-operative ] [ Designated as safety issue: No ]
    This outcome will be derived from the Tegner questionnaire.

  • Speed of resumption of work/ sports and daily activities. [ Time Frame: After 1 year post-operative ] [ Designated as safety issue: No ]
    This outcome will be derived from the FORSS (Factor Occupational Rating System Scale)questionnaire.

  • Speed of resumption of work/ sports and daily activities. [ Time Frame: After 1 year post-operative ] [ Designated as safety issue: No ]
    This outcome will be derived from a physiotherapeutic questionnaire.

  • Speed of resumption of work/ sports and daily activities. [ Time Frame: Pre-operative ] [ Designated as safety issue: No ]
    This outcome will be derived from the VAS (Visual analogue scales) questionnaire.

  • Speed of resumption of work/ sports and daily activities. [ Time Frame: Pre-operative ] [ Designated as safety issue: No ]
    This outcome will be derived from the KOOS (Knee injury and Osteoarthritis Outcome Score)questionnaire.

  • Speed of resumption of work/ sports and daily activities. [ Time Frame: Pre-operative ] [ Designated as safety issue: No ]
    This outcome will be derived from the SF-36 (Short Form Health Survey 36) questionnaire.

  • Speed of resumption of work/ sports and daily activities. [ Time Frame: Pre-operative ] [ Designated as safety issue: No ]
    This outcome will be derived from the Tegner questionnaire.

  • Speed of resumption of work/ sports and daily activities. [ Time Frame: Pre-operative ] [ Designated as safety issue: No ]
    This outcome will be derived from the FORSS (Factor Occupational Rating System Scale)questionnaire.

  • Speed of resumption of work/ sports and daily activities. [ Time Frame: Pre-operative ] [ Designated as safety issue: No ]
    This outcome will be derived from a physiotherapeutic questionnaire.


Secondary Outcome Measures:
  • The presence of a total number of complaints. [ Time Frame: pre-operative and 4 weeks, 3 months, 6 months and 1 year post-operative. ] [ Designated as safety issue: No ]
    This outcome will be derived from questionnaires: VAS, KOOS, SF-36, TEGNER, FORSS, physiotherapeutic questionnaire


Estimated Enrollment: 180
Study Start Date: February 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
No Intervention: Rest
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Post-operative meniscectomy and surgery at Ghent University Hospital

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01571102

Contacts
Contact: Peter Verdonck, MD, PhD pverdonck@yahoo.com
Contact: Aad Dhollander, MD aad.dhollander@ugent.be

Locations
Belgium
Ghent University Hospital Not yet recruiting
Ghent, Belgium, 9000
Contact: Peter Verdonck, MD, PhD       pverdonck@yahoo.com   
Contact: Aad Dhollander, MD         
Principal Investigator: Peter Verdonck, MD, PhD         
Sub-Investigator: Aad Dhollander, MD         
Sponsors and Collaborators
University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01571102     History of Changes
Other Study ID Numbers: 2012/161
Study First Received: March 28, 2012
Last Updated: February 1, 2013
Health Authority: Belgium: Ethics Committee

ClinicalTrials.gov processed this record on November 25, 2014