Lesion of the Medial MeniscusNCT02474004
Gait Analysis Meniscal Repair
A study testing medial meniscal surgery in people with Lesion of the Medial Meniscus, run by Michael Liebensteiner at 2 sites in Austria.
Trial summary
In the past it was shown, that medial partial meniscectomy (MPM) leads to an increase of the knee adduction moment (KAM) during walking. Other researches found out that an increase of the KAM is an important factor contributing to degeneration joint disease of the knee (osteoarthritis). Read more about this study
- Who is it for?
- Ages 10 to 60 years
- Conditions the study is for
- Lesion of the Medial Meniscus
- What is being tested?
- medial meniscal surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesAustria
- Study dates
- Feb 2012to Feb 2017
- 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 10 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- previous or current diseases of the back and the other joints of the lower limbs
- any form of inflammatory arthritis
- diabetes
- neurological disorders
- other conditions that may affect gait
Trial locations and contacts
2 sites in 1 country.
Austria2 sites, 2 recruiting
- Recruiting
Innsbruck Medical University, Dept. Orthop. Surgery
Innsbruck, Tyrol, 6020
Michael C Liebensteiner, MD, PhD
- Recruiting
Sportsclinic Austria
Innsbruck, Tyrol, 6020
Christian Fink, Prof. MD
About this study
Official title: 3D-gait Analysis in Patients With Medial Meniscus Repair vs. Partial Meniscectomy
In the past it was shown, that medial partial meniscectomy (MPM) leads to an increase of the knee adduction moment (KAM) during walking. Other researches found out that an increase of the KAM is an important factor contributing to degeneration joint disease of the knee (osteoarthritis). Today, medial menicus repair (MMR) is favoured by many knee surgeons, because preserving as much of the meniscus as possible is assumed to delay degenerative joint disease.
The investigators hypothesize significant differences in knee adduction moments between patients treated with partial medial meniscectomy vs. patients treated with medial meniscus repair (hypothesis 1; major hypothesis). Additionally, it is hypothesized that: the mentioned groups differ with respect to other kinetic and kinematic key parameters of gait (hypothesis 2) and that the knee adduction moment correlates with the clinical outcome as determined by a typical knee score (hypothesis 3).
- Conditions
- Lesion of the Medial Meniscus
- Being tested
- medial meniscal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medial meniscal surgeryProcedure or surgery
one group/arm has meniscal repair as part of clinical routine one group/arm has meniscal partial resection as part of clinical routine both groups have gait analysis \& knee scores 6 mo after the procedures
| Study group | Role | What they receive |
|---|---|---|
| medial meniscus repair | Experimental | patients receiving medial meniscus repair Receives: Procedure: medial meniscal surgery |
| medial partial meniscectomy | Active comparator | patients having medial partial meniscectomy Receives: Procedure: medial meniscal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
knee adduction moment [Nm/kg]
a parameter of gait analysis
Measured: once after 6 months
Secondary outcomes (1)
set of kinetic, kinematic and temporospatial gait parameters
other gait parameters
Measured: once after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study startFeb 2012
- Primary completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lesion of the Medial MeniscusStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael Liebensteiner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Liebensteiner, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474004
- Sponsor's protocol ID
- GAIT-Men1
- Status last verified
- Jul 2016
- First submitted
- 4 Jun 2015
- Last updated
- 19 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D-gait Analysis in Patients With Medial Meniscus Repair vs. Partial Meniscectomy
- ClinicalTrials.gov ID
- NCT02474004
- Acronym / sponsor ID
- GAIT-Men1
- Conditions
- Lesion of the Medial Meniscus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Michael LiebensteinerUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2017 (estimated)
- First posted
- 17 Jun 2015 (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 the past it was shown, that medial partial meniscectomy (MPM) leads to an increase of the knee adduction moment (KAM) during walking. Other researches found out that an increase of the KAM is an important factor contributing to degeneration joint disease of the knee (osteoarthritis). Today, medial menicus repair (MMR) is favoured by many knee surgeons, because preserving as much of the meniscus as possible is assumed to delay degenerative joint disease.
The investigators hypothesize significant differences in knee adduction moments between patients treated with partial medial meniscectomy vs. patients treated with medial meniscus repair (hypothesis 1; major hypothesis). Additionally, it is hypothesized that: the mentioned groups differ with respect to other kinetic and kinematic key parameters of gait (hypothesis 2) and that the knee adduction moment correlates with the clinical outcome as determined by a typical knee score (hypothesis 3).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| medial meniscus repair | Experimental | Procedure: medial meniscal surgerypatients receiving medial meniscus repair |
| medial partial meniscectomy | Active comparator | Procedure: medial meniscal surgerypatients having medial partial meniscectomy |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- previous or current diseases of the back and the other joints of the lower limbs
- any form of inflammatory arthritis
- diabetes
- neurological disorders
- other conditions that may affect gait
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 |
|---|---|---|
| medial meniscal surgeryone group/arm has meniscal repair as part of clinical routine one group/arm has meniscal partial resection as part of clinical routine both groups have gait analysis \& knee scores 6 mo after the procedures | Procedure or surgery | medial meniscus repair, medial partial meniscectomy |
Primary outcome
knee adduction moment [Nm/kg]
Time frame: once after 6 months
a parameter of gait analysis
1 secondary outcome
set of kinetic, kinematic and temporospatial gait parameters
Time frame: once after 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2016.
Related trials for Lesion of the Medial Meniscus
Not yet recruitingObservational study
A Study on Different Treatments for Knee Osteoarthritis Caused by Damaged Roots of the Medial Meniscus.
Osteoarthritis, Meniscus Lesion
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medial meniscal surgery in people with Lesion of the Medial Meniscus, run by Michael Liebensteiner at 2 sites in Austria.
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 0 inclusion and 5 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 19 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael C Liebensteiner, MD, PhD (+43 512 504 80547, michael.liebensteiner@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knee adduction moment [Nm/kg] (time frame: once after 6 months). 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 19 Jul 2016.