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

NCT01508728 | Terminated Phase 2

• 1 other identifier: 2011-A00821-40
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 3

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

Keywords

unoperated severe sprain of the knee with partial or total rupture of the anterior; cruciate ligament and medial or lateral collateral ligament

Outcome Measures

Primary Outcomes (1)

• 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

  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)

Study Arms (2)

Active vibration

EXPERIMENTAL

Device: ORTHOSENS orthosis

Placebo Vibration

PLACEBO COMPARATOR

Device: ORTHOSENS orthosis

Interventions

ORTHOSENS orthosis DEVICE

with active vibration

Active vibration

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thuasne: lead

Study Sites (3)

Clinique Axium

Aix-en-Provence, 13090, France

Location

Institut de Chirurgie Orthopédique et Sportive

Marseille, 13008, France

Location

Hôpital Sainte-Marguerite

Marseille, 13009, France

Location

MeSH Terms

Conditions

Sprains and Strains

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2012
• First Posted: January 12, 2012
• Study Start: March 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 25, 2014

Record last verified: 2014-09

Locations

FR (3)