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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham | Sham Comparator | Under conscience sedation, a nick in the skin is made to mimic marrow aspiration. Laser inserted into knee joint but not turned on. |
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| Laser Only | Experimental | Under conscience sedation, a nick in the skin is made to mimic marrow aspiration. Laser fiber is inserted into knee over an 18 gauge needle and micro-channels are made into the damaged cartilage. |
|
| Laser plus Marrow | Experimental | Under conscience sedation, a 10mL marrow aspiration is performed. Laser fiber is inserted into the knee over an 18 gauge needle and micro-channels are made into the damaged cartilage. After the channels are made, marrow aspirate is injected over the same 18 gauge needle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser Cell Therapy | Procedure | Bone marrow aspirate combined with laser to alter the cartilage matrix to facilitate repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| MRI | Pre procedure MRI and post MRI is taken to measure disease modification | one year |
| VAS Score | Pre procedure and post procedure Pain score | one year |
| KOOS score | Pre procedure and post procedure Improvement in daily living and pain | one year |
| Treadmill Test | Pre procedure and post procedure, the patient will walk for 12 minutes with a gradual increase and a change in pain will be evaluated | one year |
| Swiss Ball wall squat test | Swiss Ball wall squat test to asses functional recovery. | one year |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gennie Arbogast, DO | Contact | 7402648000 | garbogast@trinityhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Michael Scarpone | Trinity Sports Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trinity Sports Medicine | Steubenville | Ohio | 43952 | United States |
Data will not be shared unless the principal investigator decides to make public either through podium presentations or written publication.
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Blinded trial. Three groups. Sham, laser only, laser plus marrow. Stage 2 and 3 OA of one or both knees
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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.
| D012216 |
| Rheumatic Diseases |