MeniscectomyNCT01571102
Impact of Physiotherapy on Short-term Outcome After Meniscectomy
A study testing Therapy and Exercise therapy in people with Meniscectomy, run by University Hospital, Ghent at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meniscectomy
- What is being tested?
- Therapy and Exercise therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-operative meniscectomy and surgery at Ghent University Hospital
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Meniscectomy
- Being tested
- Therapy, Exercise therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TherapyBehavioural
week 1 - 4: 3 times/week, week 5 - 8: 2 times/week, duration 40min.
Exercise therapyBehavioural
week 1 - 4: 3 times/week, week 5 - 8: 2 times/week, duration 30 min.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Therapy |
| Rest | No intervention | Not described |
| 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. Receives: Behavioral: Exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speed of resumption of work/ sports and daily activities.
This outcome will be derived from the VAS (Visual analogue scales) questionnaire.
Measured: 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.
Measured: 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.
Measured: After 4 weeks post-operative
Speed of resumption of work/ sports and daily activities.
This outcome will be derived from the Tegner questionnaire.
Measured: 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.
Measured: After 4 weeks post-operative
Speed of resumption of work/ sports and daily activities.
This outcome will be derived from a physiotherapeutic questionnaire.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After 3 months post-operative
Speed of resumption of work/ sports and daily activities.
This outcome will be derived from the Tegner questionnaire.
Measured: 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.
Measured: After 3 months post-operative
Speed of resumption of work/ sports and daily activities.
This outcome will be derived from a physiotherapeutic questionnaire.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After 6 months post-operative
Speed of resumption of work/ sports and daily activities.
This outcome will be derived from the Tegner questionnaire.
Measured: 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.
Measured: After 6 months post-operative
Speed of resumption of work/ sports and daily activities.
This outcome will be derived from a physiotherapeutic questionnaire.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After 1 year post-operative
Speed of resumption of work/ sports and daily activities.
This outcome will be derived from the Tegner questionnaire.
Measured: 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.
Measured: After 1 year post-operative
Speed of resumption of work/ sports and daily activities.
This outcome will be derived from a physiotherapeutic questionnaire.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-operative
Speed of resumption of work/ sports and daily activities.
This outcome will be derived from the Tegner questionnaire.
Measured: 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.
Measured: Pre-operative
Speed of resumption of work/ sports and daily activities.
This outcome will be derived from a physiotherapeutic questionnaire.
Measured: Pre-operative
Secondary outcomes (1)
The presence of a total number of complaints.
This outcome will be derived from questionnaires: VAS, KOOS, SF-36, TEGNER, FORSS, physiotherapeutic questionnaire
Measured: pre-operative and 4 weeks, 3 months, 6 months and 1 year post-operative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startFeb 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeniscectomyStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571102
- Sponsor's protocol ID
- 2012/161
- Status last verified
- Dec 2014
- First submitted
- 28 Mar 2012
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Impact of Physiotherapy on Short-term Outcome After Meniscectomy.
- ClinicalTrials.gov ID
- NCT01571102
- Acronym / sponsor ID
- 2012/161
- Conditions
- Meniscectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 4 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| physiotherapy | Active comparator | Behavioral: TherapyPromote mobility, strength and stability and exercises to reduce pain and swelling depending on the phase of tissue repair and evolution of the patient. |
| Rest | No intervention | – |
| Home exercises | Active comparator | Behavioral: Exercise therapyPromote mobility, strength and stability and exercises to reduce pain and swelling depending on the phase of tissue repair and evolution of the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Post-operative meniscectomy and surgery at Ghent University Hospital
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapyweek 1 - 4: 3 times/week, week 5 - 8: 2 times/week, duration 40min. | Behavioural | physiotherapy |
| Exercise therapyweek 1 - 4: 3 times/week, week 5 - 8: 2 times/week, duration 30 min. | Behavioural | Home exercises |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Speed of resumption of work/ sports and daily activities.
Time frame: Pre-operative
This outcome will be derived from the Tegner questionnaire.
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.
Speed of resumption of work/ sports and daily activities.
Time frame: Pre-operative
This outcome will be derived from a physiotherapeutic questionnaire.
1 secondary outcome
The presence of a total number of complaints.
Time frame: pre-operative and 4 weeks, 3 months, 6 months and 1 year post-operative.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapy and Exercise therapy in people with Meniscectomy, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speed of resumption of work/ sports and daily activities. (time frame: After 4 weeks post-operative). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.