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

Sprain Clinical Trial

— ORTHOSENS  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01508728
• Other study ID #: 2011-A00821-40
• Secondary ID: 2011-A00821-40
• Status: Terminated
• Phase: Phase 2
• First received: January 3, 2012
• Last updated: September 24, 2014
• Start date: March 2012
• Est. completion date: September 2013

Study information

• Verified date: September 2014
• Source: Thuasne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Française de Sécurité SAnitaire des Produits de Santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 104
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Sprain

Intervention

Device:
• ORTHOSENS orthosis
with active vibration
• ORTHOSENS orthosis
with placebo vibration

Locations

Country	Name	City	State
France	Clinique Axium	Aix en Provence
France	Hôpital Sainte-Marguerite	Marseille
France	Institut de Chirurgie Orthopédique et Sportive	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Thuasne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Period of time required to recover a normal knee range of motion			No
Secondary	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)	No
Secondary	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)	Yes
Secondary	Safety according to adverse event records		At any time during subject participation (12 weeks)	Yes
Secondary	Psychological state according to the Incredibly Short Profile of Mood States		3 times per week from week 1 to week 12	Yes
Secondary	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)	No