SprainPhase 2ORTHOSENSNCT01508728
Efficacy Study of a Sensory Feedback Knee Orthosis in Patients Suffering From Unoperated Severe Knee Sprain
A Phase 2 study testing ORTHOSENS orthosis in people with Sprain, run by Thuasne at 3 sites in France.
Trial summary
Ortheses are commonly used for the repair of damage to the musculoskeletal system. However, immobility, by itself, causes serious side effects that require long and costly rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sprain
- What is being tested?
- ORTHOSENS orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 3 sitesFrance
- Study dates
- Mar 2012to Sep 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients agreeing to participate in the study and who signed informed consent.
- Indication of bracing immobilization for 6 weeks following a unoperated severe sprain of the knee with partial or total rupture of the anterior cruciate ligament and a peripheral injury, medial or lateral collateral ligament, with or without meniscal lesion.
- MRI scan confirming the nature of the lesion to be provided
- during the inclusion visit.
- Patients whose knee is immobilized for 7 to 15 days in Zimmer-like splint.
- Patients aged from 18 to 65.
- Patients agreeing to choose their physiotherapist from a list provided by the investigators.
- Patient (s) with insurance coverage.
Who cannot join
- Patients with a bucket handle meniscus tear.
- Patients with a pentad injury.
- Patients with osteochondral fragments.
- Patients with a knee fracture apart from "Segond fracture" and "bone bruise".
- Patients who underwent ligament surgery for the concerned knee.
- Patients with a bone lesion which may interfere with the knee joint(distal femur, proximal tibia, patella).
Show all 11Show fewer
- Patients with any history of rupture of the central pivot (anterior cruciate ligament and posterior cruciate ligament), of lateral ligament planes rupture (medial collateral ligament and lateral collateral) or lateral planes ligament injury without rupture, dating from less than 1 year.
- Patients whose sprain results from an accident at work.
- Patients with an inability / unwillingness to follow protocol requirements.
- Patients for whom there would be no suitable brace size in the Thuasne range.
- Patients participating in another clinical study or who have tested an experimental drug within 30 days prior to study entry. - Patients with another disease which, according to the investigator, may interfere with the results or the conduct of the trial and thus justify their non-inclusion in the study.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Clinique Axium
Aix-en-Provence, 13090
Institut de Chirurgie Orthopédique et Sportive
Marseille, 13008
Hôpital Sainte-Marguerite
Marseille, 13009
About this study
Ortheses are commonly used for the repair of damage to the musculoskeletal system. However, immobility, by itself, causes serious side effects that require long and costly rehabilitation. The Sensory Feedback Ortheses allow to artificially maintain the proprioceptive and tactile flow in order to maintain the activity of their host brain areas and thus reduce significantly the usual therapy duration. The clinical study Orthosens will evaluate the efficacy and safety of the Sensory Feedback Ortheses.
- Conditions
- Sprain
- Being tested
- ORTHOSENS orthosis
- Keywords
- unoperated severe sprain of the knee with partial or total rupture of the anterior, cruciate ligament and medial or lateral collateral ligament
- Medical subject headings
- Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORTHOSENS orthosisDevice
with active vibration
ORTHOSENS orthosisDevice
with placebo vibration
| Study group | Role | What they receive |
|---|---|---|
| Active vibration | Experimental | Not described Receives: Device: ORTHOSENS orthosis |
| Placebo Vibration | Placebo comparator | Not described Receives: Device: ORTHOSENS orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Period of time required to recover a normal knee range of motion
Secondary outcomes (5)
Period of time required to recover a normal knee range of motion with a passive mobilization
Measured: The day of inclusion, then 3 times per week during 12 weeks (except at weeks 8 and 12: 4 measurements)
Pain according to Visual Analogic Scale
Measured: The day of inclusion, then 3 times per week during 12 weeks (except at weeks 8 and 12: 4 measurements)
Safety according to adverse event records
Measured: At any time during subject participation (12 weeks)
Psychological state according to the Incredibly Short Profile of Mood States
Measured: 3 times per week from week 1 to week 12
Knee functional state according to IKDC, KOOS and KOOS-PS scores
Measured: The Day of inclusion, then 3 times per week during 12 weeks (except at weeks 8 and 12: 4 measurements)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SprainStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thuasne
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508728
- Sponsor's protocol ID
- 2011-A00821-40
- Other IDs
- 2011-A00821-40
- Acronym
- ORTHOSENS
- Status last verified
- Sep 2014
- First submitted
- 3 Jan 2012
- Last updated
- 25 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of a Sensory Feedback Knee Orthosis in Patients Suffering From Unoperated Severe Knee Sprain
- ClinicalTrials.gov ID
- NCT01508728
- Acronym / sponsor ID
- ORTHOSENS / 2011-A00821-40
- Conditions
- Sprain
- Keywords
- unoperated severe sprain of the knee with partial or total rupture of the anterior, cruciate ligament and medial or lateral collateral ligament
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- ThuasneIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 12 Jan 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.
Ortheses are commonly used for the repair of damage to the musculoskeletal system. However, immobility, by itself, causes serious side effects that require long and costly rehabilitation. The Sensory Feedback Ortheses allow to artificially maintain the proprioceptive and tactile flow in order to maintain the activity of their host brain areas and thus reduce significantly the usual therapy duration. The clinical study Orthosens will evaluate the efficacy and safety of the Sensory Feedback Ortheses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active vibration | Experimental | Device: ORTHOSENS orthosis |
| Placebo Vibration | Placebo comparator | Device: ORTHOSENS orthosis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients agreeing to participate in the study and who signed informed consent.
- Indication of bracing immobilization for 6 weeks following a unoperated severe sprain of the knee with partial or total rupture of the anterior cruciate ligament and a peripheral injury, medial or lateral collateral ligament, with or without meniscal lesion.
- MRI scan confirming the nature of the lesion to be provided
- during the inclusion visit.
- Patients whose knee is immobilized for 7 to 15 days in Zimmer-like splint.
Key exclusion criteria (11 listed)
- Patients with a bucket handle meniscus tear.
- Patients with a pentad injury.
- Patients with osteochondral fragments.
- Patients with a knee fracture apart from "Segond fracture" and "bone bruise".
- Patients who underwent ligament surgery for the concerned knee.
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 |
|---|---|---|
| ORTHOSENS orthosiswith active vibration | Device | Active vibration |
| ORTHOSENS orthosiswith placebo vibration | Device | Placebo Vibration |
Primary outcome
Period of time required to recover a normal knee range of motion
5 secondary outcomes
Period of time required to recover a normal knee range of motion with a passive mobilization
Time frame: The day of inclusion, then 3 times per week during 12 weeks (except at weeks 8 and 12: 4 measurements)
Pain according to Visual Analogic Scale
Time frame: The day of inclusion, then 3 times per week during 12 weeks (except at weeks 8 and 12: 4 measurements)
Safety according to adverse event records
Time frame: At any time during subject participation (12 weeks)
Psychological state according to the Incredibly Short Profile of Mood States
Time frame: 3 times per week from week 1 to week 12
Knee functional state according to IKDC, KOOS and KOOS-PS scores
Time frame: The Day of inclusion, then 3 times per week during 12 weeks (except at weeks 8 and 12: 4 measurements)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ORTHOSENS orthosis in people with Sprain, run by Thuasne at 3 sites in France.
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 8 inclusion and 11 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: stopped early, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early. Results are not available in the source record.
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?
Period of time required to recover a normal knee range of motion. 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 25 Sep 2014.