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

T

THUASNE

Status and phase

Terminated
Phase 2

Conditions

Sprain

Treatments

Device: ORTHOSENS orthosis

Study type

Interventional

Funder types

Industry

Identifiers

NCT01508728
2011-A00821-40 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

104 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

104 participants in 2 patient groups, including a placebo group

Active vibration
Experimental group
Treatment:
Device: ORTHOSENS orthosis
Placebo Vibration
Placebo Comparator group
Treatment:
Device: ORTHOSENS orthosis

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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