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NCT06138548 | NOT YET RECRUITING | Subchondral Insufficiency Fracture

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

Stanford University

Information provided by (Responsible Party):

Seth Sherman

Brief Summary:

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). Our 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 we are using the TFNs in the way they are intended to be used via FDA approval.

Condition or disease

Subchondral Insufficiency Fracture

Intervention/treatment

Ossiofiber® Trimmable Fixation Nail

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 10 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Bio-Integrative, Fiber-Reinforced Kneebar for Treating Subchondral Insufficiency of the Knee
Actual Study Start Date : 2025-07
Estimated Primary Completion Date : 2027-07
Estimated Study Completion Date : 2027-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Has had knee pain in study knee lasting at least 3 months
  • 2. Candidate for knee arthroscopy due to meniscal tear, loose body, unstable articular cartilage or mechanical symptoms.
Exclusion Criteria
  • 1. Current tobacco use or has quit within 3 months of study enrolment.
  • 2. Substance abuse history.
  • 3. Diabetes mellitus, HbA1c\>8
  • 4. High surgical risk due to pre-existing conditions.
  • 5. Currently pregnant or has plans to become pregnant prior to surgery.
  • 6. Active infection or history of chronic infection in study knee.
  • 7. 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)
Bio-Integrative, Fiber-Reinforced Kneebar for Treating Subchondral Insufficiency of the Knee

Location Details

NCT06138548

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How to Participate

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Locations

Not yet recruiting

United States, California

Stanford University

Stanford, California, United States, 94305