Laser Cell Therapy for Knee Cartilage Repair

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Combined Effect of IPG Medical Charlie Laser and Bone Marrow Grafting on Cartilage Defects of the Knee

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: Laser Cell Therapy


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Blinded trial. Three groups. Sham, laser only, laser plus marrow. Stage 2 and 3 OA of one or both knees
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham<br>Under conscience sedation, a nick in the skin is made to mimic marrow aspiration. Laser inserted into knee joint but not turned on. | Procedure: Laser Cell Therapy<br>* Bone marrow aspirate combined with laser to alter the cartilage matrix to facilitate repair<br>|
| Experimental: Laser Only<br>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. | Procedure: Laser Cell Therapy<br>* Bone marrow aspirate combined with laser to alter the cartilage matrix to facilitate repair<br>|
| Experimental: Laser plus Marrow<br>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. | Procedure: Laser Cell Therapy<br>* Bone marrow aspirate combined with laser to alter the cartilage matrix to facilitate repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |