Rehabilitation Post-meniscectomyPhase 2MENFISNCT01775345
Assessment of Different Rehabilitation Treatments After a Partial Removal of the Meniscus
A Phase 2 study testing Isotonic exercises, Isokinetic exercises and Isotonic and isokinetic exercises in people with Rehabilitation Post-meniscectomy, run by University Rovira i Virgili at 1 site in Spain.
Trial summary
To determine that rehabilitation treatment for a partial meniscectomy is more efficient in the functional recovery of the knee. Set in the fewest possible sessions, what treatment has benefits that last beyond the physical and what is the best cost-effectiveness. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rehabilitation Post-meniscectomy
- What is being tested?
- Isotonic exercises, Isokinetic exercises and Isotonic and isokinetic exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2013to Dec 2015
- Phase
- Phase 2
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women of between 18 and 60 years
- Surgical Intervention: partial meniscectomy of the internal meniscus
- Informed consent
Who cannot join
- Re-meniscectomy
- Associate injury of crossed ligaments
- Degenerative osteoarthritis of knee degree the II, III or IV
- Morbid obesity
- Infectious diseases in the skin, cutaneous injuries and / or zones of hypoesthesia
- Participants with malignant tumors
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- Participants with cognitive or sensory alterations
- Volunteers who have taken part in a study in the last 3 months
- Lack of collaboration of the patient
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Sant Joan
Reus, 43201
Carme Casajuana, PT, +34 977310300 ext. 50630, ccasajuana@grupsagessa.com
Roser González, PT
About this study
Official title: Assessment of Different Treatments of Muscle Strengthening in Post-meniscectomy Knee.
To determine that rehabilitation treatment for a partial meniscectomy is more efficient in the functional recovery of the knee. Set in the fewest possible sessions, what treatment has benefits that last beyond the physical and what is the best cost-effectiveness.
It is expected that the combination of isotonic and isokinetic exercises in post-meniscectomy physiotherapy allows faster and less costly patient rehabilitate than the current isotonic protocol.
Read the detailed description
Longitudinal randomized single-blind study, 81 patients (27 per group; 3 groups), 18 to 60 years, underwent surgery meniscus and performing rehabilitation at the University Hospital Sant Joan de Reus. The first rehabilitation sessions will be common (manual therapy, electrotherapy, proprioceptive reeducation, isometric exercises, bike exercise and cryotherapy). From Session 10, will be randomized into 3 groups: group 1 protocol added isotonic exercises, group 2 isokinetic exercises and group 3 isotonic and isokinetic exercises.
The principal variable will be the maximum force peak of the muscle. An evaluation of other parameters such as knee function (Lysholm Test) and the degree of pain (VAS) will be performed.
- Conditions
- Rehabilitation Post-meniscectomy
- Being tested
- Isotonic exercises, Isokinetic exercises, Isotonic and isokinetic exercises, ST
- Keywords
- Partial meniscectomy, Physiotherapy, Isokinetics, Cost-effectiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isotonic exercisesProcedure or surgery
20 sessions of muscular force work by means of isotonic exercises, that to the beginning will consist of 2 series of 10 repetitions to 60, 65 and 70 % of a MR.
Later, a gradual progression will be realized and the load will be increasing up to being able to realize, before the session 30: 2 series of 15 repetitions to 60, 65 and 70 %, of 1MR, 2 series of 10 repetitions to 75 and 80 % of 1MR and one series of 6 repetitions to 85 and 90 % of 1MR.
Isokinetic exercisesProcedure or surgery
20 sessions of muscular force work by means of isokinetic exercises, that to the beginning will consist of 2 series of 10 repetitions to 150, 180 and 210 º / seg in the first session and it will be increasing in a progressive and gradual way up to being able to realize, before the last session: 3 series of 15 repetitions to 180 º, 210 º and 240 º / seg, 2 series of 10 repetitions to 120 º and 150 º / seg and 2 series of 6 repetitions of 60 º and 90 º / seg.
Isotonic and isokinetic exercisesProcedure or surgery
20 sessions of muscular force work by means of isotonic and isokinetic exercises. To the beginning it will consist of 1 series of 10 repetitions to 150, 180 and 210 º / seg and 1 series of 10 repetitions to 60, 65 and 70 % of 1 MR. A gradual progression will be realized up to reaching, before the last session, a load of: 2 series of 15 repetitions to 180, 210 and 240 º / seg, 1 series from 10 to 120 and 150 º / seg and 1 series of 6 repetitions to 60 and 90 º / seg, and 1 series of 15 repetitions to 60, 65 and 70 %, of 1MR, 1 series of 10 repetitions to 75 and 80 % of 1MR and 1 series of 3 repetitions to 85 and 90 % of 1MR.
STProcedure or surgery
Also called Standard therapy
Standard therapy: The 10 first rehabilitation sessions will be common (manual therapy, electrotherapy, proprioceptive reeducation, isometric exercises, bike exercise and cryotherapy)
| Study group | Role | What they receive |
|---|---|---|
| Isotonic exercises + ST | Experimental | This group will realize 20 sessions of muscular force work by means of isotonic exercises, that to the beginning will consist of 2 series of 10 repetitions to 60, 65 and 70 % of a maximum repetition (MR)(MR is the maximum resistance that a muscle can conquer).
Later, a gradual progression will be realized and the load will be increasing up to being able to realize, before the session 30: 2 series of 15 repetitions to 60, 65 and 70 %, of 1MR, 2 series of 10 repetitions to 75 and 80 % of 1MR and one series of 6 repetitions to 85 and 90 % of 1MR. Receives: Procedure: Isotonic exercises; Procedure: ST |
| Isokinetic exercises + ST | Experimental | This group will realize 20 sessions of muscular force work by means of isokinetic exercises, that to the beginning will consist of 2 series of 10 repetitions to 150, 180 and 210 º / seg in the first session and it will be increasing in a progressive and gradual way up to being able to realize, before the last session: 3 series of 15 repetitions to 180 º, 210 º and 240 º / seg, 2 series of 10 repetitions to 120 º and 150 º / seg and 2 series of 6 repetitions of 60 º and 90 º / seg. Receives: Procedure: Isokinetic exercises; Procedure: ST |
| Isotonic and isokinetic exercises + ST | Experimental | This group will realize 20 sessions of muscular force work by means of isotonic and isokinetic exercises. To the beginning it will consist of 1 series of 10 repetitions to 150, 180 and 210 º / seg and 1 series of 10 repetitions to 60, 65 and 70 % of 1MR. A gradual progression will be realized up to reaching, before the last session, a load of: 2 series of 15 repetitions to 180, 210 and 240 º / seg, 1 series from 10 to 120 and 150 º / seg and 1 series of 6 repetitions to 60 and 90 º / seg, and 1 series of 15 repetitions to 60, 65 and 70 %, of 1MR, 1 series of 10 repetitions to 75 and 80 % of 1MR and 1 series of 3 repetitions to 85 and 90 % of 1MR. Receives: Procedure: Isotonic and isokinetic exercises; Procedure: ST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum force peak in flexion of 60 º / seg and 180 º / seg, and extension of 60 º / seg and 180 º / seg. The assessment will be comparative. It will be realized in both the affected knee and the healthy knee.
We will observe the maximum force peak in flexion of 60 º / seg and 180 º / seg, and extension of 60 º / seg and 180 º / seg. Both the valuation and the work of muscular involution with isokinetic exercises will fulfil with an isokinetic dynamometer Biodex 3.
Measured: 7 weeks
Secondary outcomes (1)
Knee functionality with the Lysholm Test.
Questionnaire with 8 questions that the patient must answer with regard to the functionality of the affected knee. Maximum functionality 100 points.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rehabilitation Post-meniscectomyStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitari Sant Joan de Reus
- Responsible party
- Principal investigator, M. Rosa Nogués, University Rovira i Virgili
- Investigators
- Carme Casajuana, PT, Study director, Hospital Universitari Sant Joan de Reus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01775345
- Sponsor's protocol ID
- MENFIS
- Acronym
- MENFIS
- Status last verified
- Mar 2014
- First submitted
- 22 Jan 2013
- Last updated
- 17 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Different Treatments of Muscle Strengthening in Post-meniscectomy Knee.
- ClinicalTrials.gov ID
- NCT01775345
- Acronym / sponsor ID
- MENFIS / MENFIS
- Conditions
- Rehabilitation Post-meniscectomy
- Keywords
- Partial meniscectomy, Physiotherapy, Isokinetics, Cost-effectiveness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Collaborators
- Hospital Universitari Sant Joan de Reus
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 24 Jan 2013 (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.
To determine that rehabilitation treatment for a partial meniscectomy is more efficient in the functional recovery of the knee. Set in the fewest possible sessions, what treatment has benefits that last beyond the physical and what is the best cost-effectiveness.
It is expected that the combination of isotonic and isokinetic exercises in post-meniscectomy physiotherapy allows faster and less costly patient rehabilitate than the current isotonic protocol.
Detailed description
Longitudinal randomized single-blind study, 81 patients (27 per group; 3 groups), 18 to 60 years, underwent surgery meniscus and performing rehabilitation at the University Hospital Sant Joan de Reus. The first rehabilitation sessions will be common (manual therapy, electrotherapy, proprioceptive reeducation, isometric exercises, bike exercise and cryotherapy). From Session 10, will be randomized into 3 groups: group 1 protocol added isotonic exercises, group 2 isokinetic exercises and group 3 isotonic and isokinetic exercises.
The principal variable will be the maximum force peak of the muscle. An evaluation of other parameters such as knee function (Lysholm Test) and the degree of pain (VAS) will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Isotonic exercises + ST | Experimental | Procedure: Isotonic exercises, Procedure: STThis group will realize 20 sessions of muscular force work by means of isotonic exercises, that to the beginning will consist of 2 series of 10 repetitions to 60, 65 and 70 % of a maximum repetition (MR)(MR is the maximum resistance that a muscle can conquer). Later, a gradual progression will be realized and the load will be increasing up to being able to realize, before the session 30: 2 series of 15 repetitions to 60, 65 and 70 %, of 1MR, 2 series of 10 repetitions to 75 and 80 % of 1MR and one series of 6 repetitions to 85 and 90 % of 1MR. |
| Isokinetic exercises + ST | Experimental | Procedure: Isokinetic exercises, Procedure: STThis group will realize 20 sessions of muscular force work by means of isokinetic exercises, that to the beginning will consist of 2 series of 10 repetitions to 150, 180 and 210 º / seg in the first session and it will be increasing in a progressive and gradual way up to being able to realize, before the last session: 3 series of 15 repetitions to 180 º, 210 º and 240 º / seg, 2 series of 10 repetitions to 120 º and 150 º / seg and 2 series of 6 repetitions of 60 º and 90 º / seg. |
| Isotonic and isokinetic exercises + ST | Experimental | Procedure: Isotonic and isokinetic exercises, Procedure: STThis group will realize 20 sessions of muscular force work by means of isotonic and isokinetic exercises. To the beginning it will consist of 1 series of 10 repetitions to 150, 180 and 210 º / seg and 1 series of 10 repetitions to 60, 65 and 70 % of 1MR. A gradual progression will be realized up to reaching, before the last session, a load of: 2 series of 15 repetitions to 180, 210 and 240 º / seg, 1 series from 10 to 120 and 150 º / seg and 1 series of 6 repetitions to 60 and 90 º / seg, and 1 series of 15 repetitions to 60, 65 and 70 %, of 1MR, 1 series of 10 repetitions to 75 and 80 % of 1MR and 1 series of 3 repetitions to 85 and 90 % of 1MR. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Men and women of between 18 and 60 years
- Surgical Intervention: partial meniscectomy of the internal meniscus
- Informed consent
Key exclusion criteria (9 listed)
- Re-meniscectomy
- Associate injury of crossed ligaments
- Degenerative osteoarthritis of knee degree the II, III or IV
- Morbid obesity
- Infectious diseases in the skin, cutaneous injuries and / or zones of hypoesthesia
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 |
|---|---|---|
| Isotonic exercises20 sessions of muscular force work by means of isotonic exercises, that to the beginning will consist of 2 series of 10 repetitions to 60, 65 and 70 % of a MR. Later, a gradual progression will be realized and the load will be increasing up to being able to realize, before the session 30: 2 series of 15 repetitions to 60, 65 and 70 %, of 1MR, 2 series of 10 repetitions to 75 and 80 % of 1MR and one series of 6 repetitions to 85 and 90 % of 1MR. | Procedure or surgery | Isotonic exercises + ST |
| Isokinetic exercises20 sessions of muscular force work by means of isokinetic exercises, that to the beginning will consist of 2 series of 10 repetitions to 150, 180 and 210 º / seg in the first session and it will be increasing in a progressive and gradual way up to being able to realize, before the last session: 3 series of 15 repetitions to 180 º, 210 º and 240 º / seg, 2 series of 10 repetitions to 120 º and 150 º / seg and 2 series of 6 repetitions of 60 º and 90 º / seg. | Procedure or surgery | Isokinetic exercises + ST |
| Isotonic and isokinetic exercises20 sessions of muscular force work by means of isotonic and isokinetic exercises. To the beginning it will consist of 1 series of 10 repetitions to 150, 180 and 210 º / seg and 1 series of 10 repetitions to 60, 65 and 70 % of 1 MR. A gradual progression will be realized up to reaching, before the last session, a load of: 2 series of 15 repetitions to 180, 210 and 240 º / seg, 1 series from 10 to 120 and 150 º / seg and 1 series of 6 repetitions to 60 and 90 º / seg, and 1 series of 15 repetitions to 60, 65 and 70 %, of 1MR, 1 series of 10 repetitions to 75 and 80 % of 1MR and 1 series of 3 repetitions to 85 and 90 % of 1MR. | Procedure or surgery | Isotonic and isokinetic exercises + ST |
| STAlso: Standard therapyStandard therapy: The 10 first rehabilitation sessions will be common (manual therapy, electrotherapy, proprioceptive reeducation, isometric exercises, bike exercise and cryotherapy) | Procedure or surgery | Isokinetic exercises + ST, Isotonic and isokinetic exercises + ST, Isotonic exercises + ST |
Primary outcome
Maximum force peak in flexion of 60 º / seg and 180 º / seg, and extension of 60 º / seg and 180 º / seg. The assessment will be comparative. It will be realized in both the affected knee and the healthy knee.
Time frame: 7 weeks
We will observe the maximum force peak in flexion of 60 º / seg and 180 º / seg, and extension of 60 º / seg and 180 º / seg. Both the valuation and the work of muscular involution with isokinetic exercises will fulfil with an isokinetic dynamometer Biodex 3.
1 secondary outcome
Knee functionality with the Lysholm Test.
Time frame: 7 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2014.
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.
Carme Casajuana, PT study director
Hospital Universitari Sant Joan de Reus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Isotonic exercises, Isokinetic exercises and Isotonic and isokinetic exercises in people with Rehabilitation Post-meniscectomy, run by University Rovira i Virgili at 1 site in Spain.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 17 Mar 2014. 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 Spain. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carme Casajuana, PT (+34 977310300 ext. 50630, ccasajuana@grupsagessa.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum force peak in flexion of 60 º / seg and 180 º / seg, and extension of 60 º / seg and 180 º / seg. The assessment will be comparative. It will be realized in both the affected knee and the healthy knee. (time frame: 7 weeks). 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 17 Mar 2014.