NL-OMON41663
Completed
Not Applicable
Evaluation of the Latella Implant System for Lateralization of the Iliotibial Band to Offload the Medial Condyle for Pain Relief in Patients with Medial Osteoarthritis * A Safety Study - COTERA-1
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- arthritis on the inner side of the knee
- Sponsor
- Cotera, Inc.
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. History of pain diagnosed as due to medial osteoarthritis with failure of pain relief from non\-operative therapy
- •OR failure of pain relief 6 months post arthroscopic treatment for medial osteoarthritis (see exclusion criteria for excluded procedures)
- •2\. Age: 30 \* 65 years
- •3\. Weight: Less than 110 kg
- •4\. Kellgren\-Lawrence scores: Grades 2\-3
- •5\. Willing and able to understand and sign the informed consent
Exclusion Criteria
- •\* Varus angle \> 10 degrees
- •\* Osteoporosis
- •\* Rheumatoid arthritis
- •\* Immunosupressive disorders, for example, diabetes
- •\* Chronic steroid use
- •\* History of heterotopic ossification
- •\* Ligament instability
- •\* Joint instability
- •\* Capsule contracture
- •\* Ligament contracture
Outcomes
Primary Outcomes
Not specified
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