Catabolic Marker Levels After Platelet Poor Plasma (PPP) Lavage
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 35 - 85 |
| Updated: | 4/17/2018 |
| Start Date: | July 2016 |
| End Date: | December 2017 |
Assessing Catabolic Marker Levels in the Knee Synovial Fluid Microenvironment After Lavage With Platelet Poor Plasma (PPP)
The purpose of this study is to understand how the components of osteoarthritic knee joint
fluid (synovial fluid) change after lavage treatment with platelet poor plasma. Additionally,
the study participants will complete outcome questionnaire surveys before and after the
treatment in conjunction with when synovial fluid is removed from the knee (2, 4, and 6 weeks
after lavage). This data will help determine if the treatment of an osteoarthritic knee joint
with platelet poor plasma lavage is a suitable stand-alone therapy or to improve outcome by
preparing a patient's knee for further regenerative therapies.
fluid (synovial fluid) change after lavage treatment with platelet poor plasma. Additionally,
the study participants will complete outcome questionnaire surveys before and after the
treatment in conjunction with when synovial fluid is removed from the knee (2, 4, and 6 weeks
after lavage). This data will help determine if the treatment of an osteoarthritic knee joint
with platelet poor plasma lavage is a suitable stand-alone therapy or to improve outcome by
preparing a patient's knee for further regenerative therapies.
The objective of this study is to quantify the levels of catabolic markers in osteoarthritic
(OA) knee synovial fluid microenvironment (ME) before lavage treatment with platelet poor
plasma (PPP) and to determine whether the anti-catabolic capabilities of the PPP are
sustainable or if the diseased synovial fluid returns to pre-lavage catabolic marker levels
within the 6 week period of the study.
This data will be used to determine if treatment of a diseased (OA) knee with PPP lavage
would be a suitable therapy for knee OA patients either as a stand-alone treatment or to
improve outcome by preparing a patient's knee microenvironment for further treatment with
cellular therapies. Incidence of post-operative complications, adverse events, re-injections,
and surgical intervention; change in pain score will be considered while determining these
direct and indirect associations upon completion of the PPP lavage treatment. Correlation of
subject reported clinical outcomes for the PPP lavage treatment will be evaluated to
determine whether the treatment provides beneficial clinical outcomes.
(OA) knee synovial fluid microenvironment (ME) before lavage treatment with platelet poor
plasma (PPP) and to determine whether the anti-catabolic capabilities of the PPP are
sustainable or if the diseased synovial fluid returns to pre-lavage catabolic marker levels
within the 6 week period of the study.
This data will be used to determine if treatment of a diseased (OA) knee with PPP lavage
would be a suitable therapy for knee OA patients either as a stand-alone treatment or to
improve outcome by preparing a patient's knee microenvironment for further treatment with
cellular therapies. Incidence of post-operative complications, adverse events, re-injections,
and surgical intervention; change in pain score will be considered while determining these
direct and indirect associations upon completion of the PPP lavage treatment. Correlation of
subject reported clinical outcomes for the PPP lavage treatment will be evaluated to
determine whether the treatment provides beneficial clinical outcomes.
Inclusion Criteria:
- 1) Voluntary signature of the institutional review board approved Informed Consent
- 2) Male or female ages 35-85
- 3) Pain, swelling, and/or functional disability in the affected knee consistent with
osteoarthritis in the knee joint
- 4) Physical examination consistent with osteoarthritis as observed on imaging
- 5) Unilateral or bilateral Kellgren-Lawrence grade 3 or greater knee osteoarthritis
(moderate to severe OA) and/or diagnostic MRI imaging of the affected knee showing
osteoarthritis (i.e. chondral loss, fissuring, defect, bone marrow lesion, meniscus
tear, synovial thickening, etc…)
- 6) Mild effusion upon ultrasound evaluation.
- 7) Is independent, ambulatory, and can comply with all postoperative evaluations and
visits
Exclusion Criteria:
- 1) Knee injections of any type within 3 months prior to the study.
- 2) Knee surgery within 6 months prior to the study.
- 3) Inflammatory or auto-immune based joint diseases or other lower extremity pathology
(e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis,
polymyalgia, polymyositis, gout pseudogout)
- 4) Quinolone or Statin induced myopathy/tendinopathy
- 5) Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh
- 6) Contraindications for MRI
- 7) Condition represents a worker's compensation case
- 8) Currently involved in a health-related litigation procedure
- 9) Is pregnant
- 10) Bleeding disorders
- 11) Currently taking anticoagulant or immunosuppressive medication
- 12)Allergy or intolerance to study medication
- 13)Use of chronic opioid
- 14)Documented history of drug abuse within six months of treatment
- 15)Any other condition, that in the opinion of the investigator, that would preclude
the patient from enrollment
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