Investigating Orthobiologics After PRP and Photobiomodulation for Knee Osteoarthritis

Investigating Orthobiologics After Platelet-Rich Plasma and Photobiomodulation Treatment of Knee Osteoarthritis

This research assesses the effects that Photobiomodulation Therapy (PBMT) has on Intra-articular administered Plasma-Rich Platelet (PRP) injections for Knee Osteoarthritis (KOA) treatment through evaluations of synovial and serum inflammatory and reparative biomarkers.

A comparison of Physical Therapy (PT) vs PT + PRP vs PT + PBMT vs PT + PRP + PBMT for KOA treatment is made. The relationship between self-reported pain and functionality and treatment mechanisms is analyzed along with an analysis of the intersectionality between participant self-reported pain and functionality and medicine markers across treatment groups. These aims seek to inform current treatment practices in treating KOA and returning Active-Duty Service Members to duty readiness.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Physical Therapy; Biological: Platelet-Rich Plasma Injection; Device: Photobiomodulation Therapy

Detailed Description

Post Traumatic Knee Osteoarthritis (PTOA) is a degenerative joint disease resulting in the loss of cartilage due to wear and tear or by an uncharacteristic force applied to the knee. This disease appears frequently in Active-Duty Service Members and is rising in prominence where over 20,000 Knee Osteoarthritis (KOA) cases were detected over a 10-year period. Current treatments such as physical therapy (PT), braces, oral pain relievers, corticosteroid, and hyaluronic acid injections for KOA only address the quality of life and the symptoms but have not demonstrated a reverse in disease progression. Studies have found that Platelet-Rich Plasma (PRP) has shown to be a promising treatment 6-12 months post procedure and may slow KOA progression.

Photobiomodulation therapy (PBMT) is a non-invasive treatment option shown to reduce pain, increase function, and decrease stiffness with or without therapeutic exercises in KOA patients. In combination, PRP and PBMT may increase the recovery benefits while and potentially reduce KOA progression while seeking therapy. The exact dosage for the optimization of treatment with both PRP and PBMT still needs to be analyzed and understood. Therefore, this study will investigate four treatment arms utilizing PT, PT plus PRP, PT plus PBMT, and PT plus PRP plus PBMT. This discover based and randomized control trial will investigate the effect of PBMT and intra-articular administered PRP treatment on clinical outcomes (e.g., pain scores) and biomolecular signatures (DNA, RNA, or protein levels) in the blood or synovial spaces.The participants' intersectionality between pain, functionality, and precision medicine markers will be analyzed across treatment groups. Follow-up data in the form of questionnaires and activity logs will be collected to monitor study progression.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nana-king A Karikari; Phone Number: 253-228-7347; Email: nkarikari@genevausa.org
• Study Contact Backup: Name: Scott P Grogan; Phone Number: 253-968-2083; Email: kneephotomed@genevausa.org

Study Locations

• United States
  • Washington
    • Tacoma, Washington, United States, 98431
      • Recruiting
      • Madigan Army Medical Center
      • Contact: Robert Rossi; Phone Number: 551-404-1923; Email: rrossi@genevausa.org
      • Sub-Investigator: Joseph W Galvin
      • Contact: Nana-king A Karikari; Phone Number: 253-228-7347; Email: nkarikari@genevausa.org
      • Sub-Investigator: Jeremy D Schroeder
      • Sub-Investigator: Nelson A Hager

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• DEERS Eligible
• Between 18-64 (Inclusive)
• Civilian
• Contractor
• Active Duty Service Member

• Knee Osteoarthritis diagnosis

  a) at least 3 of the following:

  1. >50 years old
  2. Morning stiffness < 30 minutes
  3. Crepitus on active movements
  4. Tenderness of the bony margins of the joint
  5. Bony enlargement
  6. No palpable warmth
• Fluent in speaking and reading English
• Ability to commit to study intervention and follow-up
• Willing to avoid prohibited treatments while enrolled in the study (NSAIDs/COX-2 inhibitors and ASAs for 5 days prior to and 2 weeks following study injection or beginning of treatment, and oral steroids, steroid injections, and viscos supplementation)
• Radiographic evidence of knee osteoarthritis as assessed by Kellgren-Lawrence grade 1 or higher

Exclusion Criteria:

• Current participation in other research studies for knee OA
• Previous enrollment for contralateral knee
• Hx of arthroscopic surgery on the study knee within the past year
• Hx of arthroplasty on the study knee
• Received dry needling within the past 4 weeks
• Received prolotherapy (e.g. CSI or PRP injection), within past month
• Recent (within the last 3 months) lower extremity injury (e.g., ankle sprain, meniscus tear or sprain, etc.) that required professional medical attention, and occurred in the ipsilateral extremity of the study knee
• Confounding, coexisting pathology suspected to be the primary source of their pain [e.g., acute meniscal tear (with mechanical symptoms), ligamentous changes (with clinical instability) or hemarthrosis]
• Current or chronic sciatica (lumbosacral radiculopathy) resulting in chronic or intermittent lower extremity pain, numbness, or tingling
• Diagnosis of neuropathy affecting sensation to pain
• Diagnosis of inflammatory arthropathy
• Diagnosis of fibromyalgia or chronic fatigue syndrome
• Hx of adverse reaction to PRP injection (either documented in the medical record or shared by the patient during screening)
• Tattoo in treatment area
• Diagnosis of porphyria (light induced allergy) or photosensitive eczema
• Current use of medications associated with sensitivity to heat or light (e.g., amiodarone, chlorpromazine, doxycycline, hydrochlorothiazide, nalidixic acid, naproxen, piroxicam, tetracycline, thioridazine, voriconazole)
• Current use of pacemaker
• Hx of underlying cardiac disease
• Diagnosis of autoimmune disease
• Albinism
• Current pregnancy or plans to become pregnant during intervention period
• Hx of memory problems, dementia, and/or impaired decision-making ability
• Any other serious medical conditions(s) that might preclude optimal outcome and/or interfere with participation (e.g.), intra-articular sepsis, bacteremia, fracture, joint instability, rheumatoid arthritis, osteoporosis, cancer, coagulopathy, etc.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Physical Therapy (PT) Only; All participants will complete a standard of care PT program addressing individual strength, mobility, and flexibility deficits in both proximal and distal muscle groups. The provider may also use other modalities to address distal issues. If a participant has not been placed on profile at the time of consent, a profile may be written by the study medical provider to ensure limitation of activities, as appropriate.	Other: Physical Therapy; The PT treatment participants receive in this study will be standard of care; that is, the PT treatment regimen will not be standardized across study participants and/or dictated by study-specific criteria. Participants will be referred to the Physical Therapy Department at the Madigan Army Medical Center (MAMC). Number of PT treatments will be documented on a follow-up Chart Review.; Other Names: SOC PT
Active Comparator: PT + Platelet-Rich Plasma (PRP); PRP Preparation: The PRP will be prepared following standard technique by drawing 60cc blood from the participant through venipuncture and spinning the blood sample in a centrifuge (for approximately 17 minutes), adjusting for leukocyte poor-platelet rich plasma (LP-PRP). This sample will be prepared by the study provider. Any leftover blood will be safely discarded per standard protocols. A small portion of the pre-spin whole blood (approximately 1 cc) and post-spin injectant PRP (approximately 1 cc) will be sent to MAMC Department of Pathology and Laboratory Services (DPALS) for complete blood count (CBC) cytology to monitor standardization and reproducibility. This portion will be labeled by participant ID and study. De-identified hardcopy results will be obtained from MAMC DPALS, and CBC results will be reported on Appendix G (CBC Results CRF). Post-procedural instructions will be provided in a participant handout.	Other: Physical Therapy; The PT treatment participants receive in this study will be standard of care; that is, the PT treatment regimen will not be standardized across study participants and/or dictated by study-specific criteria. Participants will be referred to the Physical Therapy Department at the Madigan Army Medical Center (MAMC). Number of PT treatments will be documented on a follow-up Chart Review.; Other Names: SOC PT; Biological: Platelet-Rich Plasma Injection; PRP injection procedures will follow current clinical recommendation and standard operating procedures. Prior to the injection, the area will be sterilely prepared and anesthetized with either ethyl chloride spray or lidocaine (limited to the cutaneous and subcutaneous layer, so as not to alter the synovial contents). Then, the participant will receive LP-PRP injection in the affected knee area under ultrasound guidance. Qualified study providers will inject 2-5cc LP-PRP using an 18-gauge 1/5-inch needle for both aspiration and subsequent injection. Study providers will select the injection portal they are most comfortable with, in order to achieve an accurate intra-articular injection. The PRP injection procedure is expected to take approximately one hour.; Other Names: PRP
Active Comparator: PT + Photobiomodulation Treatment (PBMT); In addition to SOC PT, the PBMT group will receive PBM treatment, as outlined below. PBM treatments will occur 3 times each week, for 3 weeks. A member of the study team will measure the treatment area according to a standard protocol and calculate the treatment time (approximately 5-20 minutes). PBMT will be delivered at 6 J/cm2 and 25W and applied in a serpentine pattern to the knee area. Participants will be asked to refrain from using perfumes or plant extracts (e.g., St. John's Wort) in the treatment area(s), as this can increase skin photosensitivity.	Other: Physical Therapy; The PT treatment participants receive in this study will be standard of care; that is, the PT treatment regimen will not be standardized across study participants and/or dictated by study-specific criteria. Participants will be referred to the Physical Therapy Department at the Madigan Army Medical Center (MAMC). Number of PT treatments will be documented on a follow-up Chart Review.; Other Names: SOC PT; Device: Photobiomodulation Therapy; PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. PBMT will be delivered at 6 J/cm^2 and applied in a circular pattern to the knee area.; Other Names: PBMT
Active Comparator: PT + PRP + PBMT; In addition to SOC PT, the PRP and PBMT group will receive PRP treatment and PBMT treatments. Participants in this group will start PBMT treatments on the same day after receiving the study PRP injection. On the day of the PRP injection, the participant will be instructed to rest for 5-10 minutes prior to the PBMT application and team member will ensure the participant is comfortable not in pain. Immediately following the study injection, the team member will take care not to provide the PBMT over the injected area; however, all subsequent PBMT treatments will be delivered to the knee where the PRP was injected.	Other: Physical Therapy; The PT treatment participants receive in this study will be standard of care; that is, the PT treatment regimen will not be standardized across study participants and/or dictated by study-specific criteria. Participants will be referred to the Physical Therapy Department at the Madigan Army Medical Center (MAMC). Number of PT treatments will be documented on a follow-up Chart Review.; Other Names: SOC PT; Biological: Platelet-Rich Plasma Injection; PRP injection procedures will follow current clinical recommendation and standard operating procedures. Prior to the injection, the area will be sterilely prepared and anesthetized with either ethyl chloride spray or lidocaine (limited to the cutaneous and subcutaneous layer, so as not to alter the synovial contents). Then, the participant will receive LP-PRP injection in the affected knee area under ultrasound guidance. Qualified study providers will inject 2-5cc LP-PRP using an 18-gauge 1/5-inch needle for both aspiration and subsequent injection. Study providers will select the injection portal they are most comfortable with, in order to achieve an accurate intra-articular injection. The PRP injection procedure is expected to take approximately one hour.; Other Names: PRP; Device: Photobiomodulation Therapy; PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. PBMT will be delivered at 6 J/cm^2 and applied in a circular pattern to the knee area.; Other Names: PBMT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kellgren Lawrence Classification System (KL)	Kellgren Lawrence Classification System (KL) will score the radiographic evidence of the participant's knee osteoarthritis. Minimum Score: Grade 0 (none): definite absence of X-ray changes of knee OA Maximum Score: Grade 4 (severe): Large osteophyte formation, joint space narrowing, definite bone end deformity Higher grades indicate a worse outcome.	Baseline
Defense and Veterans Pain Rating Scale (DVPRS)	Defense and Veterans Pain Rating Scale (DVPRS) will capture current pain severity. Minimum Score: 0 (no pain) Maximum Score: 10 (As bad as it could be, nothing else matters) A higher score indicates, increasing pain.	Baseline
Defense and Veterans Pain Rating Scale (DVPRS)	Defense and Veterans Pain Rating Scale (DVPRS) will capture current pain severity. Minimum Score: 0 (no pain) Maximum Score: 10 (As bad as it could be, nothing else matters) A higher score indicates, increasing pain.	Daily, for 6 weeks
Single Assessment Numeric Evaluation (SANE)	Single Assessment Numeric Evaluation (SANE) will rate the participant's knee osteoarthritis condition as a percentage from normal. Minimum Score: 0% (Abnormal) Maximum Score: 100% (Fully Normal) An increasing percentage means the closer the participant feels their knee is back to normal function.	Baseline
Single Assessment Numeric Evaluation (SANE)	Single Assessment Numeric Evaluation (SANE) will rate the participant's knee osteoarthritis condition as a percentage from normal. Minimum Score: 0% (Abnormal) Maximum Score: 100% (Fully Normal) An increasing percentage means the closer the participant feels their knee is back to normal function.	Daily, for 6 weeks
Knee Injury Osteoarthritis Outcome Score (KOOS)	Knee Injury Osteoarthritis Outcome Score (KOOS) will ask the participants questions while thinking about their injured knee symptoms in the past week. Minimum Score: None Maximum Score: Extreme On a per question basis, the participant states how significant their knee symptoms are.	Baseline
Knee Injury Osteoarthritis Outcome Score (KOOS)	Knee Injury Osteoarthritis Outcome Score (KOOS) will ask the participants questions while thinking about their injured knee symptoms in the past week. Minimum Score: None Maximum Score: Extreme On a per question basis, the participant states how significant their knee symptoms are.	3-week follow-up
Knee Injury Osteoarthritis Outcome Score (KOOS)	Knee Injury Osteoarthritis Outcome Score (KOOS) will ask the participants questions while thinking about their injured knee symptoms in the past week. Minimum Score: None Maximum Score: Extreme On a per question basis, the participant states how significant their knee symptoms are.	6-week follow-up
The Veterans Rand 12 Item Health Survey (VR-12)	The Veterans Rand 12 Item Health Survey (VR-12) asks participants about their feelings and how well they can do their usual activities. Minimum Score 1: Poor Maximum Score 1: Excellent Refers to a participant's general health. Minimum Score 2: Yes, limited a lot Maximum Score 2: No, not limited at all Refers to activity, how their health has limited them. Minimum Score 3: No, none of the time Maximum Score 3: Yes, all of the time How Physical health has that impacted accomplishments and the kind of work of other activities. Minimum Score 4: Not at all Maximum Score 4: Extremely Refers to how pain interferes with normal work. Minimum Score 5: All of the time Maximum Score 5: None of the time Refers to feeling calm, having energy, and whether they feel downhearted. Minimum Score 6: Much worse Maximum Score 6: Much better A comparison of physical health compared to a year ago and a comparison of emotional health compared to a year ago.	Baseline
The Veterans Rand 12 Item Health Survey (VR-12)	The Veterans Rand 12 Item Health Survey (VR-12) will ask participants about how they feel and how well they are able to do their usual activities. Minimum Score 1: Poor Maximum Score 1: Excellent Refers to a participant's general health. Minimum Score 2: Yes, limited a lot Maximum Score 2: No, not limited at all Refers to activity, how their health has limited them. Minimum Score 3: No, none of the time Maximum Score 3: Yes, all of the time How Physical health has that impacted accomplishments and the kind of work of other activities. Minimum Score 4: Not at all Maximum Score 4: Extremely Refers to how pain interferes with normal work. Minimum Score 5: All of the time Maximum Score 5: None of the time Refers to feeling calm, having energy, and whether they feel downhearted. Minimum Score 6: Much worse Maximum Score 6: Much better A comparison of physical health compared to a year ago and a comparison of emotional health compared to a year ago.	3-week follow-up
The Veterans Rand 12 Item Health Survey (VR-12)	The Veterans Rand 12 Item Health Survey (VR-12) will ask participants about how they feel and how well they are able to do their usual activities. Minimum Score 1: Poor Maximum Score 1: Excellent Refers to a participant's general health. Minimum Score 2: Yes, limited a lot Maximum Score 2: No, not limited at all Refers to activity, how their health has limited them. Minimum Score 3: No, none of the time Maximum Score 3: Yes, all of the time How Physical health has that impacted accomplishments and the kind of work of other activities. Minimum Score 4: Not at all Maximum Score 4: Extremely Refers to how pain interferes with normal work. Minimum Score 5: All of the time Maximum Score 5: None of the time Refers to feeling calm, having energy, and whether they feel downhearted. Minimum Score 6: Much worse Maximum Score 6: Much better A comparison of physical health compared to a year ago and a comparison of emotional health compared to a year ago.	6-week follow-up
Biorepository Blood Draw for Biomarkers of Interest ADAMTS-4 &5	4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: ADAMTS-4 &5.	Baseline
Biorepository Blood Draw for Biomarkers of Interest MMP 7 & 9	4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: MMP 7 & 9.	Baseline
Biorepository Blood Draw for Biomarkers of Interest TGF-B	4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: TGF-B.	Baseline
Biorepository Blood Draw for Biomarkers of Interest Aggrecan	4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: Aggrecan.	Baseline
Biorepository Blood Draw for Biomarkers of Interest HYAL2	4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: HYAL2.	Baseline
Biorepository Blood Draw for Biomarkers of Interest CRP	4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CRP.	Baseline
Biorepository Blood Draw for Biomarkers of Interest HA	4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: HA.	Baseline
Biorepository Blood Draw for Biomarkers of Interest CD14	4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD14.	Baseline
Biorepository Blood Draw for Biomarkers of Interest CD16	4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD16.	Baseline
Biorepository Blood Draw for Biomarkers of Interest CD64	4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD64.	Baseline
Knee Joint Aspiration for Biomarkers of Interest CD64	Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD64.	Baseline
Knee Joint Aspiration for Biomarkers of Interest CD16	Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD16.	Baseline
Knee Joint Aspiration for Biomarkers of Interest CD14	Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD14.	Baseline
Knee Joint Aspiration for Biomarkers of Interest HA	Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: HA.	Baseline
Knee Joint Aspiration for Biomarkers of Interest CRP	Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CRP.	Baseline
Knee Joint Aspiration for Biomarkers of Interest HYAL2	Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: HYAL2.	Baseline
Knee Joint Aspiration for Biomarkers of Interest Aggrecan	Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: Aggrecan.	Baseline
Knee Joint Aspiration for Biomarkers of Interest TGF-B	Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: Aggrecan.	Baseline
Knee Joint Aspiration for Biomarkers of Interest MMP 7 & 9	Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: MMP 7& 9.	Baseline
Knee Joint Aspiration for Biomarkers of Interest ADAMTS-4 & 5	Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: ADAMTS-4 & 5.	Baseline
Biorepository Blood Draw for Biomarkers of Interest CD64.	4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD64.	6-week follow-up
Biorepository Blood Draw for Biomarkers of Interest CD16	4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD16.	6-week follow-up
Biorepository Blood Draw for Biomarkers of Interest CD14	4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD14.	6-week follow-up
Biorepository Blood Draw for Biomarkers of Interest HA	4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: HA.	6-week follow-up
Biorepository Blood Draw for Biomarkers of Interest CRP	4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CRP.	6-week follow-up
Biorepository Blood Draw for Biomarkers of Interest HYAL2	4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: HYAL2.	6-week follow-up
Biorepository Blood Draw for Biomarkers of Interest Aggrecan	4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: Aggrecan.	6-week follow-up
Biorepository Blood Draw for Biomarkers of Interest TGF-B	4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: TGF-B.	6-week follow-up
Biorepository Blood Draw for Biomarkers of Interest MMP 7 & 9	4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: MMP 7 & 9.	6-week follow-up
Biorepository Blood Draw for Biomarkers of Interest ADAMTS-4 & 5	4 ml of blood collected in K2/EDTA tube, 4 ml of blood collected in heparin tube, 3 ml of blood collected in DNA/RNA tube. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: ADAMTS-4 & 5.	6-week follow-up
Knee Joint Aspiration for Biomarkers of Interest ADAMTS-4 & 5	Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: ADAMTS-4 & 5.	6-week follow-up
Knee Joint Aspiration for Biomarkers of Interest MMP 7 & 9	Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: MMP 7 & 9.	6-week follow-up
Knee Joint Aspiration for Biomarkers of Interest TGF-B	Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: TGF-B.	6-week follow-up
Knee Joint Aspiration for Biomarkers of Interest Aggrecan	Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: Aggrecan.	6-week follow-up
Knee Joint Aspiration for Biomarkers of Interest HYAL2	Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: HYAL2.	6-week follow-up
Knee Joint Aspiration for Biomarkers of Interest CRP	Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CRP.	6-week follow-up
Knee Joint Aspiration for Biomarkers of Interest HA	Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: HA.	6-week follow-up
Knee Joint Aspiration for Biomarkers of Interest CD14	Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD14.	6-week follow-up
Knee Joint Aspiration for Biomarkers of Interest CD16	Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD16.	6-week follow-up
Knee Joint Aspiration for Biomarkers of Interest CD64	Synovial fluid from the knee will be extracted and stored in the biorepository. Once sufficient sampling has been met, batch analyses will be completed for biomarker capture including: CD64.	6-week follow-up
Complete Blood Count (CBC) Analysis WBC	Whole blood and PRP spin analysis will be completed to analyze total blood content of WBC.	Baseline
Complete Blood Count (CBC) Analysis RBC	Whole blood and PRP spin analysis will be completed to analyze total blood content of RBC.	Baseline
Complete Blood Count (CBC) Analysis HGB	Whole blood and PRP spin analysis will be completed to analyze total blood content of HGB.	Baseline
Complete Blood Count (CBC) Analysis HCT	Whole blood and PRP spin analysis will be completed to analyze total blood content of HCT.	Baseline
Complete Blood Count (CBC) Analysis PLT	Whole blood and PRP spin analysis will be completed to analyze total blood content of PLT.	Baseline
Complete Blood Count (CBC) Analysis LYM%	Whole blood and PRP spin analysis will be completed to analyze total blood content of LYM%.	Baseline
Complete Blood Count (CBC) Analysis LYM#	Whole blood and PRP spin analysis will be completed to analyze total blood content of LYM#.	Baseline
Complete Blood Count (CBC) Analysis MON%	Whole blood and PRP spin analysis will be completed to analyze total blood content of MON%.	Baseline
Complete Blood Count (CBC) Analysis GRA%	Whole blood and PRP spin analysis will be completed to analyze total blood content of GRA%.	Baseline
Complete Blood Count (CBC) Analysis Neutrophil%	Whole blood and PRP spin analysis will be completed to analyze total blood content of Neutrophil%.	Baseline
Complete Blood Count (CBC) Analysis Eosinophil%,	Whole blood and PRP spin analysis will be completed to analyze total blood content of Eosinophil%.	Baseline
Complete Blood Count (CBC) Analysis Basophil%	Whole blood and PRP spin analysis will be completed to analyze total blood content of Basophil%.	Baseline
Complete Blood Count (CBC) Analysis MON#	Whole blood and PRP spin analysis will be completed to analyze total blood content of MON#.	Baseline

Collaborators and Investigators

• Sponsor: Musculoskeletal Injury Rehabilitation Research for Operational Readiness
• Collaborators: The Geneva Foundation
• Investigators: Principal Investigator: Scott P Grogan, Madigan Army Medical Center

Publications and helpful links

General Publications

• Rayegani SM, Raeissadat SA, Heidari S, Moradi-Joo M. Safety and Effectiveness of Low-Level Laser Therapy in Patients With Knee Osteoarthritis: A Systematic Review and Meta-analysis. J Lasers Med Sci. 2017 Summer;8(Suppl 1):S12-S19. doi: 10.15171/jlms.2017.s3. Epub 2017 Aug 29.
• Paolillo FR, Paolillo AR, Joao JP, Frasca D, Duchene M, Joao HA, Bagnato VS. Ultrasound plus low-level laser therapy for knee osteoarthritis rehabilitation: a randomized, placebo-controlled trial. Rheumatol Int. 2018 May;38(5):785-793. doi: 10.1007/s00296-018-4000-x. Epub 2018 Feb 26.
• Arnoczky SP, Sheibani-Rad S. The basic science of platelet-rich plasma (PRP): what clinicians need to know. Sports Med Arthrosc Rev. 2013 Dec;21(4):180-5. doi: 10.1097/JSA.0b013e3182999712. Erratum In: Sports Med Arthrosc. 2014 Jun;22(2):150. Shebani-Rad, Shahin [corrected to Sheibani-Rad, Shahin].
• Molloy JM, Pendergrass TL, Lee IE, Chervak MC, Hauret KG, Rhon DI. Musculoskeletal Injuries and United States Army Readiness Part I: Overview of Injuries and their Strategic Impact. Mil Med. 2020 Sep 18;185(9-10):e1461-e1471. doi: 10.1093/milmed/usaa027.
• O'Connell B, Wragg NM, Wilson SL. The use of PRP injections in the management of knee osteoarthritis. Cell Tissue Res. 2019 May;376(2):143-152. doi: 10.1007/s00441-019-02996-x. Epub 2019 Feb 13.
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Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2023
• Primary Completion (Estimated): May 10, 2024
• Study Completion (Estimated): May 10, 2024

Study Registration Dates

• First Submitted: October 26, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Photomedicine Project 11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes