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

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT06138548
Status
Enrolling By Invitation

Conditions

  • Subchondral Insufficiency Fracture

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ossiofiber® Trimmable Fixation Nail — DEVICE
    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.\*

Study Details

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.

Key Dates

Start date
Oct 31, 2025
Status verified
Nov 2025
Primary completion
Jul 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
10 participants (estimated)

Arms

  • Arm: Subchondral Insufficiency
    Those who have subchondral insufficiency with tibial or femoral overload in the knee and are receiving the TFNs as standard of care.

Primary Outcome Measure

Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 3 months post-operatively ]

Locations (2)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305-
Rush UniversityChicagoIllinois60612-

Find similar trials in Stanford, CA

By research site
Stanford University· Stanford, CARush University· Chicago, IL

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