Status:
TERMINATED
Efficacy Study of a Sensory Feedback Knee Orthosis in Patients Suffering From Unoperated Severe Knee Sprain
Lead Sponsor:
Thuasne
Conditions:
Sprain
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2013
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT01508728
Start Date
March 1 2012
End Date
September 1 2013
Last Update
September 25 2014
Active Locations (3)
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1
Clinique Axium
Aix-en-Provence, France, 13090
2
Institut de Chirurgie Orthopédique et Sportive
Marseille, France, 13008
3
Hôpital Sainte-Marguerite
Marseille, France, 13009