NCT04001361

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2019

Completed
17 days until next milestone

Study Start

First participant enrolled

July 15, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

June 28, 2019

Status Verified

June 1, 2019

Enrollment Period

6 months

First QC Date

June 26, 2019

Last Update Submit

June 26, 2019

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (3)

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.

Procedure: Laser Cell Therapy

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.

Procedure: Laser Cell Therapy

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.

Procedure: Laser Cell Therapy

Interventions

Laser Cell TherapyPROCEDURE

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

Laser OnlyLaser plus MarrowSham

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trinity Sports Medicine

Steubenville, Ohio, 43952, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Michael Scarpone

    Trinity Sports Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gennie Arbogast, DO

CONTACT

7402648000garbogast@trinityhealth.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Blinded trial. Three groups. Sham, laser only, laser plus marrow. Stage 2 and 3 OA of one or both knees
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2019

First Posted

June 28, 2019

Study Start

July 15, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2020

Last Updated

June 28, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Data will not be shared unless the principal investigator decides to make public either through podium presentations or written publication.

Locations

US(1)