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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Thuasne
ClinicalTrials.gov Identifier:
NCT01508728
First received: January 3, 2012
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Sprain
Device: ORTHOSENS orthosis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Further study details as provided by Thuasne:

Primary Outcome Measures:
  • Period of time required to recover a normal knee range of motion [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Period of time required to recover a normal knee range of motion with a passive mobilization [ Time Frame: The day of inclusion, then 3 times per week during 12 weeks (except at weeks 8 and 12: 4 measurements) ] [ Designated as safety issue: No ]
  • Pain according to Visual Analogic Scale [ Time Frame: The day of inclusion, then 3 times per week during 12 weeks (except at weeks 8 and 12: 4 measurements) ] [ Designated as safety issue: Yes ]
  • Safety according to adverse event records [ Time Frame: At any time during subject participation (12 weeks) ] [ Designated as safety issue: Yes ]
  • Psychological state according to the Incredibly Short Profile of Mood States [ Time Frame: 3 times per week from week 1 to week 12 ] [ Designated as safety issue: Yes ]
  • Knee functional state according to IKDC, KOOS and KOOS-PS scores [ Time Frame: The Day of inclusion, then 3 times per week during 12 weeks (except at weeks 8 and 12: 4 measurements) ] [ Designated as safety issue: No ]

Estimated Enrollment: 104
Study Start Date: March 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active vibration Device: ORTHOSENS orthosis
with active vibration
Placebo Comparator: Placebo Vibration Device: ORTHOSENS orthosis
with placebo vibration

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01508728

Locations
France
Clinique Axium
Aix en Provence, France, 13090
Hôpital Sainte-Marguerite
Marseille, France, 13009
Institut de Chirurgie Orthopédique et Sportive
Marseille, France, 13008
Sponsors and Collaborators
Thuasne
  More Information

No publications provided

Responsible Party: Thuasne
ClinicalTrials.gov Identifier: NCT01508728     History of Changes
Other Study ID Numbers: 2011-A00821-40, 2011-A00821-40
Study First Received: January 3, 2012
Last Updated: September 24, 2014
Health Authority: France: Agence Française de Sécurité SAnitaire des Produits de Santé

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

ClinicalTrials.gov processed this record on November 24, 2014