Knee Osteoarthritis
Conditions
Brief summary
Laser pulsed energy will be delivered over an optical fiber to create channels into damaged cartilage of the knee or knees. The channels have a diameter of approximately 100 microns or less and an approximate depth of 1 millimeter or less. Bone marrow aspirate will then be delivered into the damaged joint.
Detailed description
The creation of micro-channels into damaged knee cartilage will facilitate the movement of fluid into and out of the tissue to allow for more efficient nutrient diffusion. The addition of bone marrow aspirate will provide additional growth factor enriched nutrition to the tissue. The goal of this combination therapy is to facilitates the body's own reparative processes leading to improved patient well being.
Interventions
PROCEDURELaser Cell Therapy
Bone marrow aspirate combined with laser to alter the cartilage matrix to facilitate repair
Sponsors
Endocellutions
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Sham laser means laser not turned on. Sham marrow means incision in skin made but no marrow drawn. Patient under conscience sedation. MRI and outcomes measures independently measured.
Intervention model description
Blinded trial. Three groups. Sham, laser only, laser plus marrow. Stage 2 and 3 OA of one or both knees
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Kellergren grading scale of 2 or 3 in at least one compartment of either or both knees with no compartment representing a stage 4 in either knee. No significant MCL or LCL tear or laxity No significant meniscal tear. ( i.e. bucket handle)
Exclusion criteria
* Injection with the past 6 weeks * Stage 4 osteoarthritis in either knee * Uncontrolled Diabetes or any other metabolic syndrome * BMI greater than 28 * Significant lower extremity deformity * Bilateral or tri compartmental Knee OA * Adults unable to consent * Individuals who are not yet adults (infants, children, and teenagers, age \< 18) * pregnant women * Prisoners * Stage 4 osteoarthritis in either knee * Subjects, who, in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MRI | one year | Pre procedure MRI and post MRI is taken to measure disease modification |
| VAS Score | one year | Pre procedure and post procedure Pain score |
| KOOS score | one year | Pre procedure and post procedure Improvement in daily living and pain |
| Treadmill Test | one year | Pre procedure and post procedure, the patient will walk for 12 minutes with a gradual increase and a change in pain will be evaluated |
| Swiss Ball wall squat test | one year | Swiss Ball wall squat test to asses functional recovery. |
Countries
United States
Contacts
Primary ContactGennie Arbogast, DO
Outcome results
None listed