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

Primary Purpose

Sprain

Status

Terminated

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

ORTHOSENS orthosis

About this trial

This is an interventional treatment trial for Sprain focused on measuring unoperated severe sprain of the knee with partial or total rupture of the anterior, cruciate ligament and medial or lateral collateral ligament

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Clinique Axium
Institut de Chirurgie Orthopédique et Sportive
Hôpital Sainte-Marguerite

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active vibration

Placebo Vibration

Arm Description

Outcomes

Primary Outcome Measures

Period of time required to recover a normal knee range of motion

Secondary Outcome Measures

Period of time required to recover a normal knee range of motion with a passive mobilization

Pain according to Visual Analogic Scale

Safety according to adverse event records

Psychological state according to the Incredibly Short Profile of Mood States

Knee functional state according to IKDC, KOOS and KOOS-PS scores

Full Information

NCT ID

NCT01508728

First Posted

January 3, 2012

Last Updated

September 24, 2014

Sponsor

Thuasne

1. Study Identification

Unique Protocol Identification Number

NCT01508728

Brief Title

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

Acronym

ORTHOSENS

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Terminated

Study Start Date

March 2012 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Thuasne

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sprain

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active vibration

Arm Type

Experimental

Arm Title

Placebo Vibration

Arm Type

Placebo Comparator

Intervention Type

Device

Intervention Name(s)

ORTHOSENS orthosis

Intervention Description

with active vibration

Intervention Type

Device

Intervention Name(s)

ORTHOSENS orthosis

Intervention Description

with placebo vibration

Primary Outcome Measure Information:

Title

Period of time required to recover a normal knee range of motion

Secondary Outcome Measure Information:

Title

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)

Title

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)

Title

Safety according to adverse event records

Time Frame

At any time during subject participation (12 weeks)

Title

Psychological state according to the Incredibly Short Profile of Mood States

Time Frame

3 times per week from week 1 to week 12

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Clinique Axium

City

Aix en Provence

ZIP/Postal Code

13090

Country

France

Facility Name

Institut de Chirurgie Orthopédique et Sportive

City

Marseille

ZIP/Postal Code

13008

Country

France

Facility Name

Hôpital Sainte-Marguerite

City

Marseille

ZIP/Postal Code

13009

Country

France

12. IPD Sharing Statement

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

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