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Laser Cell Therapy for Knee Cartilage Repair

NCT ID: NCT04001361

Last Updated: 2019-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-15

Study Completion Date

2020-12-31

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.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinded trial. Three groups. Sham, laser only, laser plus marrow. Stage 2 and 3 OA of one or both knees
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
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.

Study Groups

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Sham

Under conscience sedation, a nick in the skin is made to mimic marrow aspiration. Laser inserted into knee joint but not turned on.

Group Type SHAM_COMPARATOR

Laser Cell Therapy

Intervention Type PROCEDURE

Bone marrow aspirate combined with laser to alter the cartilage matrix to facilitate repair

Laser Only

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.

Group Type EXPERIMENTAL

Laser Cell Therapy

Intervention Type PROCEDURE

Bone marrow aspirate combined with laser to alter the cartilage matrix to facilitate repair

Laser plus Marrow

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.

Group Type EXPERIMENTAL

Laser Cell Therapy

Intervention Type PROCEDURE

Bone marrow aspirate combined with laser to alter the cartilage matrix to facilitate repair

Interventions

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Laser Cell Therapy

Bone marrow aspirate combined with laser to alter the cartilage matrix to facilitate repair

Intervention Type PROCEDURE

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Endocellutions

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Scarpone

Role: PRINCIPAL_INVESTIGATOR

Trinity Sports Medicine

Locations

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Trinity Sports Medicine

Steubenville, Ohio, United States

Site Status

Countries

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United States

Central Contacts

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Gennie Arbogast, DO

Role: CONTACT

Phone: 7402648000

Email: [email protected]

Facility Contacts

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Gennie Arbogast

Role: primary

Other Identifiers

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LRK1

Identifier Type: -

Identifier Source: org_study_id