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

Completed

• Conditions: 10023213; arthritis on the inner side of the knee; Medial osteoarthritis; 10005944

• Registration Number: NL-OMON41663
• Lead Sponsor: Cotera, Inc.

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2017-04-05
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

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
* Radiologic evidence of patellar osteoarthritis which in the opinion of the treating physician would preclude enrollment
* History of patellar instability including: Subluxation, Dislocation, Maltracking, Excessive anterior knee pain
* Radiologic evidence of lateral osteoarthritis
* Post-traumatic osteoarthritis
* Lateral osteophytes that would underlie implant region (diagnosed via x-ray)
* Free floating bodies
* Prior surgery or trauma in or near the intended implant site which would create scar tissue and interfere with the implant surgery.
o NOTE: Partial medial meniscectomy will be allowed
* Prior anterior cruciate ligament reconstruction
* Tight Illiotibial Band or Illiotibial Band Syndrome
* Femoral or tibial bone deformity
* Bone metabolic disease not associated with osteoarthritis
* Disease affecting the connective tissue or muscle
* Continued participation in contact sports
* Less than 5 year history free of lung, colorectal, breast, thyroid, prostate, or kidney cancer
* Less than 5 year history free of primary bone tumors
* History of stroke, upper limb or lower limb motor disorders
* Bleeding diathesis
* Chronic use of anticoagulants
* Metal ion allergy
* Absolute or relative contraindication for MRI
* No fixed abode
* Substance abuse (drug or alcohol)
* For women of childbearing potential: pregnant, or willing to become pregnant during the course of the clinical investigation
* Have been exited from in another clinical study less than 30 days prior to enrollment in this clinical study, currently participating in another clinical study or plan to be enrolled in another clinical study during the course of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety is the primary endpoint of this clinical investigation and will be<br /><br>evaluated by:<br /><br>* Freedom from unanticipated serious device related adverse events up to 12<br /><br>months after implantation surgery<br /><br>* Freedom from radiographic evidence of screw loosening up to 12 months after<br /><br>implantation surgery.<br /><br>NOTE: This does not include natural disease progression.</p><br>