ORTHOSENS: Efficacy Study of a Sensory Feedback Knee Orthosis in Patients Suffering From Unoperated Severe Knee Sprain

Sponsor

Thuasne (Industry)

Overall Status

Terminated

CT.gov ID

NCT01508728

Collaborator

(none)

104

Enrollment

Locations

Arms

Duration (Months)

34.7

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Sprain	Device: ORTHOSENS orthosis Device: ORTHOSENS orthosis	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active vibration	Device: ORTHOSENS orthosis with active vibration
Placebo Comparator: Placebo Vibration	Device: ORTHOSENS orthosis with placebo vibration

Arm

Intervention/Treatment

Experimental: Active vibration

Device: ORTHOSENS orthosis

with active vibration

Placebo Comparator: Placebo Vibration

Device: ORTHOSENS orthosis

with placebo vibration

Outcome Measures

Primary Outcome Measures

Period of time required to recover a normal knee range of motion []

Secondary Outcome Measures

Period of time required to recover a normal knee range of motion with a passive mobilization [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 [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 [At any time during subject participation (12 weeks)]
Psychological state according to the Incredibly Short Profile of Mood States [3 times per week from week 1 to week 12]
Knee functional state according to IKDC, KOOS and KOOS-PS scores [The Day of inclusion, then 3 times per week during 12 weeks (except at weeks 8 and 12: 4 measurements)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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).
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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Clinique Axium	Aix en Provence	France	13090
2	Institut de Chirurgie Orthopédique et Sportive	Marseille	France	13008
3	Hôpital Sainte-Marguerite	Marseille	France	13009

Sponsors and Collaborators

Thuasne

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thuasne

ClinicalTrials.gov Identifier:

NCT01508728

Other Study ID Numbers:

2011-A00821-40
2011-A00821-40

First Posted:

Jan 12, 2012

Last Update Posted:

Sep 25, 2014

Last Verified:

Sep 1, 2014

Keywords provided by Thuasne

unoperated severe sprain of the knee with partial or total rupture of the anterior

cruciate ligament and medial or lateral collateral ligament

Additional relevant MeSH terms:

Sprains and Strains

Study Results

No Results Posted as of Sep 25, 2014