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

NCT ID: NCT01508728

Last Updated: 2014-09-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-09-30

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.

Conditions

Sprain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active vibration

Group Type: EXPERIMENTAL

ORTHOSENS orthosis

Intervention Type: DEVICE

with active vibration

Placebo Vibration

Group Type: PLACEBO_COMPARATOR

ORTHOSENS orthosis

Intervention Type: DEVICE

with placebo vibration

Interventions

ORTHOSENS orthosis

with active vibration

Intervention Type: DEVICE

ORTHOSENS orthosis

with placebo vibration

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thuasne

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique Axium

Aix-en-Provence, , France

Institut de Chirurgie Orthopédique et Sportive

Marseille, , France

Hôpital Sainte-Marguerite

Marseille, , France

Countries

France

Other Identifiers

2011-A00821-40

Identifier Type: OTHER

Identifier Source: secondary_id

2011-A00821-40

Identifier Type: -

Identifier Source: org_study_id