Partial MeniscectomyNCT02190188
The Influence of Wedge Insoles After Partial Meniscectomy
A study testing Wedge Insole 5mm and Knee Brace in people with Partial Meniscectomy, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
Research on the implications of orthotic devices and the recovery after knee arthroscopy are widely known. But only a handful of specific issues have been studied to date. However, the effect of orthotic devices on the recovery after partial meniscectomy are largely unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial Meniscectomy
- What is being tested?
- Wedge Insole 5mm and Knee Brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2014to 1 Jan 2018
- 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
- full leg x-ray to measure the leg axis
- undersigned Informed Consent Form
Who cannot join
- at the same time conducted or within one year subsequent corrective osteotomies of the leg axis
- medial meniscectomy combination and valgus
- combination of lateral meniscectomy and varus
- psychiatric or neurological comorbidities that produce a poor compliance
- forth degree cartilage lesions or evident osteoarthritis
- concomitant lesion of the collateral ligaments
- insufficient knowledge of the study language
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Orthopedic; Medical University of Innsbruck
Innsbruck, Tyrol, 6020
About this study
Official title: Effect of Orthotic Devices in the Recovery After Partial Meniscectomy
Research on the implications of orthotic devices and the recovery after knee arthroscopy are widely known. But only a handful of specific issues have been studied to date. However, the effect of orthotic devices on the recovery after partial meniscectomy are largely unknown. To our best knowledge, there are no studies that deal with the treatment of partial medial or lateral meniscectomy with wedge insoles, valgus or varus knee braces. The purpose of this study is to find out if using wedge inserts or knee orthoses improve the outcomes after partial meniscectomy.
We therefore verify the following hypothesis: In patients with partial meniscectomy can be by the postoperative use of exculpatory wedge deposits or relieving knee brace achieve a significantly better clinical outcome than without specific treatment.
- Conditions
- Partial Meniscectomy
- Being tested
- Wedge Insole 5mm, Knee Brace
- Keywords
- wedge insoles,, knee brace,, orthotic device, goal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wedge Insole 5mmDevice
Knee BraceDevice
| Study group | Role | What they receive |
|---|---|---|
| No specific treatment | No intervention | No specific treatment after partial meniscectomy |
| Wedge Insole with 5mm wedge angel | Other | Participants wear a wedge insole after partial meniscectomy Receives: Device: Wedge Insole 5mm |
| Knee Brace | Other | Participants wear a knee brace after partial meniscectomy Receives: Device: Knee Brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee-specific questionnaires which combine an activity and a quality of life score.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2017
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial MeniscectomyStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dammerer Dietmar, MD, Medical University Innsbruck
- Investigators
- Michael Liebensteiner, Priv. Doz. Mag. Dr. PhD, Principal investigator, Department of Orthopedic, Medical University of Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190188
- Sponsor's protocol ID
- 602010072014
- Other IDs
- 602011072014
- Status last verified
- Mar 2018
- First submitted
- 12 Jul 2014
- Last updated
- 23 Mar 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Orthotic Devices in the Recovery After Partial Meniscectomy
- ClinicalTrials.gov ID
- NCT02190188
- Acronym / sponsor ID
- 602010072014
- Conditions
- Partial Meniscectomy
- Keywords
- wedge insoles,, knee brace,, orthotic device, goal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 15 Jul 2014 (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.
Research on the implications of orthotic devices and the recovery after knee arthroscopy are widely known. But only a handful of specific issues have been studied to date. However, the effect of orthotic devices on the recovery after partial meniscectomy are largely unknown. To our best knowledge, there are no studies that deal with the treatment of partial medial or lateral meniscectomy with wedge insoles, valgus or varus knee braces. The purpose of this study is to find out if using wedge inserts or knee orthoses improve the outcomes after partial meniscectomy.
We therefore verify the following hypothesis: In patients with partial meniscectomy can be by the postoperative use of exculpatory wedge deposits or relieving knee brace achieve a significantly better clinical outcome than without specific treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No specific treatment | No intervention | –No specific treatment after partial meniscectomy |
| Wedge Insole with 5mm wedge angel | Other | Device: Wedge Insole 5mmParticipants wear a wedge insole after partial meniscectomy |
| Knee Brace | Other | Device: Knee BraceParticipants wear a knee brace after partial meniscectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- full leg x-ray to measure the leg axis
- undersigned Informed Consent Form
Key exclusion criteria (7 listed)
- at the same time conducted or within one year subsequent corrective osteotomies of the leg axis
- medial meniscectomy combination and valgus
- combination of lateral meniscectomy and varus
- psychiatric or neurological comorbidities that produce a poor compliance
- forth degree cartilage lesions or evident osteoarthritis
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 |
|---|---|---|
| Wedge Insole 5mm | Device | Wedge Insole with 5mm wedge angel |
| Knee Brace | Device | Knee Brace |
Primary outcome
Knee-specific questionnaires which combine an activity and a quality of life score.
Time frame: Two years
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 23 Mar 2018.
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Partial Meniscectomy, Knee Arthroscopic Surgery
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.
Michael Liebensteiner, Priv. Doz. Mag. Dr. PhD principal investigator
Department of Orthopedic, Medical University of Innsbruck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wedge Insole 5mm and Knee Brace in people with Partial Meniscectomy, run by Medical University Innsbruck at 1 site 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 2 inclusion and 7 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 23 Mar 2018. 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 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?
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?
Knee-specific questionnaires which combine an activity and a quality of life score. (time frame: Two years). 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 23 Mar 2018; AzTrials last refreshed its copy on 7 Nov 2026.