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

Sponsor

Stanford University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06138548

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Subchondral Insufficiency Fracture	Device: Ossiofiber® Trimmable Fixation Nail	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Subchondral Insufficiency Those who have subchondral insufficiency with tibial or femoral overload in the knee.	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.*

Arm

Intervention/Treatment

Experimental: Subchondral Insufficiency

Those who have subchondral insufficiency with tibial or femoral overload in the knee.

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.*

Outcome Measures

Primary Outcome Measures

Knee injury and Osteoarthritis Outcome Score (KOOS) [3 months post-operatively]
The overall KOOS score combines pain and function domains
Knee injury and Osteoarthritis Outcome Scale Score (KOOS) [6 months post-operatively]
The overall KOOS score combines pain and function domains

Secondary Outcome Measures

Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) [6 months post-operatively]
Measures the knee health of individuals following surgery
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form [6 months post-operatively]
IKDC measures: symptoms, athletic activity, and knee function.
Veterans Rand-12 (VR-12) Health Survey Scale Score [6 months post-operatively]
VR-12 combines measures of general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, fatigue , social functioning, and mental health
Numeric Pain Reported Scale Score [6 months post-operatively]
Measures a subject's perceived pain level.
PROMIS Pain Interference Score [6 months post-operatively]
Measures what level pain hinders a patient's engagement in several activities including social, cognitive, physical, and recreational activities.
PROMIS Depression Score [6 months post-operatively]
Measures self-reported negative mood (sadness, guilt), views of self (self- criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose).
PROMIS Physical Function Score [6 months post-operatively]
Measures the level of physical function for patients with a wide variety of impairments that may limit the patient's physical capability.
Incidence Assessments [Up to 24 month post-operatively.]
Assessment of the incidence of re-operations, revision surgeries, or additional management of the study knee outside of postoperative rehabilitation.
Degree of knee ligament healing [6, 12, and 24 months]
To see how the knee ligament is healing by MRI assessment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)