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Enrolling by invitation NCT06138548

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

— Observational Subchondral Insufficiency Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ossiofiber® Trimmable Fixation Nail.
Who it may be relevant to
Registry conditions: Subchondral Insufficiency Fracture. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device 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.\*

Primary outcome measures

  • Knee injury and Osteoarthritis Outcome Score (KOOS) [Time frame: 3 months post-operatively]
  • Knee injury and Osteoarthritis Outcome Scale Score (KOOS) [Time frame: 6 months post-operatively]
Secondary outcome measures (9)
  • Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) [Time frame: 6 months post-operatively]
  • International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form [Time frame: 6 months post-operatively]
  • Veterans Rand-12 (VR-12) Health Survey Scale Score [Time frame: 6 months post-operatively]
  • Numeric Pain Reported Scale Score [Time frame: 6 months post-operatively]
  • PROMIS Pain Interference Score [Time frame: 6 months post-operatively]
  • PROMIS Depression Score [Time frame: 6 months post-operatively]
  • PROMIS Physical Function Score [Time frame: 6 months post-operatively]
  • Incidence Assessments [Time frame: Up to 24 month post-operatively.]
  • Degree of knee ligament healing [Time frame: 6, 12, and 24 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 2 centers
  • Stanford University — Stanford
  • Rush University — Chicago

Identifiers

NCT: NCT06138548 · 72105

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗