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

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 Overview

• Status: Terminated
• Conditions: Sprain
• Intervention / Treatment: Device: ORTHOSENS orthosis; Device: ORTHOSENS orthosis

• Study Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Aix en Provence, France, 13090
    • Clinique Axium
  • Marseille, France, 13009
    • Hôpital Sainte-Marguerite
  • Marseille, France, 13008
    • Institut de Chirurgie Orthopédique et Sportive

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Active vibration	Device: ORTHOSENS orthosis; with active vibration; Device: ORTHOSENS orthosis; with placebo vibration
PLACEBO_COMPARATOR: Placebo Vibration	Device: ORTHOSENS orthosis; with active vibration; Device: ORTHOSENS orthosis; with placebo vibration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Period of time required to recover a normal knee range of motion

Secondary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Thuasne

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): September 1, 2013
• Study Completion (ACTUAL): September 1, 2013

Study Registration Dates

• First Submitted: January 3, 2012
• First Submitted That Met QC Criteria: January 9, 2012
• First Posted (ESTIMATE): January 12, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): September 25, 2014
• Last Update Submitted That Met QC Criteria: September 24, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: 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: Wounds and Injuries; Sprains and Strains
• Other Study ID Numbers: 2011-A00821-40 (OTHER: AFSSAPS (N° ID RCB))