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Clinical Trials/NL-OMON41663
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

Cotera, Inc.0 sites10 target enrollmentTBD

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

Registry
who.int
Start Date
TBD
End Date
April 5, 2017
Last Updated
2 years ago
Study Type
Interventional

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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