Bio-Integrative, Fiber-Reinforced Kneebar for Treating Subchondral Insufficiency of the Knee

Обзор

The OSSIOfiber® Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis and bone grafts in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast, brace). The hypothesis is that the use of OSSIOfiber® Trimmable Fixation Nails for treating subchondral insufficiency of the knee will result in improvement of patient-reported outcomes and imaging findings. The primary objective of this study is to evaluate the effectiveness of implanting bio-integrative OSSIOfiber® Trimmable Fixation Nails, organized in a bi-cortical rafter formation within the tibia or femur for the management of subchondral insufficiency. This use is not considered off-label because the TFNs are being used in the way they are intended to be used via FDA approval.

Вмешательства

• Устройство Ossiofiber® Trimmable Fixation Nail
  OSSIOfiber® Trimmable Fixation Nails are equally strong in the initial stability and fixation strength - and superior in rotational resistance to traditional metal cannulated headless compression screws.\*

Первичные конечные точки

• Knee injury and Osteoarthritis Outcome Score (KOOS) [Срок оценки: 3 months post-operatively]
• Knee injury and Osteoarthritis Outcome Scale Score (KOOS) [Срок оценки: 6 months post-operatively]

Вторичные конечные точки (9)

• Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) [Срок оценки: 6 months post-operatively]
• International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form [Срок оценки: 6 months post-operatively]
• Veterans Rand-12 (VR-12) Health Survey Scale Score [Срок оценки: 6 months post-operatively]
• Numeric Pain Reported Scale Score [Срок оценки: 6 months post-operatively]
• PROMIS Pain Interference Score [Срок оценки: 6 months post-operatively]
• PROMIS Depression Score [Срок оценки: 6 months post-operatively]
• PROMIS Physical Function Score [Срок оценки: 6 months post-operatively]
• Incidence Assessments [Срок оценки: Up to 24 month post-operatively.]
• Degree of knee ligament healing [Срок оценки: 6, 12, and 24 months]

Критерии участия

Критерии включения

• Has had knee pain in study knee lasting at least 3 months
• Candidate for knee arthroscopy due to meniscal tear, loose body, unstable articular cartilage or mechanical symptoms.

Критерии исключения

• Current tobacco use or has quit within 3 months of study enrolment.
• Substance abuse history.
• Diabetes mellitus, HbA1c>8
• High surgical risk due to pre-existing conditions.
• Currently pregnant or has plans to become pregnant prior to surgery.
• Active infection or history of chronic infection in study knee.
• Will require concomitant procedures within study knee, including but not limited to ligament reconstruction, tendon repair, meniscus repair, microfracture, osteotomy, or osteochondral transplantation. (Meniscal tears, including chronic, are acceptable if no repair is required)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 2 центра

• Stanford University — Stanford
• Rush University — Chicago

Идентификаторы

NCT: NCT06138548 · 72105

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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