Knee Osteoarthritis Clinical Trial
Official title:
Exploring the Effectiveness of Combined High Frequency Intensive Autologous Platelet Rich Plasma Injection and Genicular Nerve Blocks in Treating Patients With Moderate to Severe Degrees of Knee Osteoarthritis
Osteoarthritis (OA) of the knees is the most common degenerative disorder seen in a
rehabilitation outpatient clinic. It is characterized by structural changes in the articular
cartilage and the surrounding tissues. The understanding of its pathophysiology is still
unclear. Knee OA patients are often troubled with knee pain and functional disturbance.
Several studies have shown that the earlier the injection of autologous platelet rich plasma
(PRP) to treat early stages of knee OA, the better the treatment outcome. However, there are
controversies as to whether PRP injections can also be effective in treating patients with
moderate to severe degrees of knee OA. Synovial fluid (SF) is in contact with the primary
tissues affected by OA (cartilage and synovium). Identifying the SF biomarkers can provide us
with crucial information in monitoring the PRP treatment response.
PRP is blood plasma that is rich in autologous platelets. Platelet releases growth factors
and cytokines that can stimulate the healing of soft tissue structures. However, the amount
of platelets in human blood is not concentrated. Purification and centrifugation procedures
are needed to concentrate these platelets. The human knee cartilage is contained inside the
knee joint and has scarce blood supply. When the cartilage is injured, growth factors can
hardly reach this area to repair the cartilage. Therefore, many studies have suggested early
usage of PRP in treating knee OA. Some studies have stated that the effect of PRP in treating
knee OA is superior to that of hyaluronic acid (HA). Recent studies have recommended the
application of high frequency PRP injections (ex/ intra-articular (IA) PRP injections on a
weekly basis) in treating patients with more severe degrees of knee OA. Prolotherapy using
hyperosmolar dextrose solution has been shown to have some positive effectiveness in treating
patients with knee OA. Higher percentage, such as > 12.5% of dextrose water, may stimulate
cartilage repair. Lower percentage, such as 5% dextrose water, has been documented to play an
essential role in anti-inflammation, and pain reduction.
Status | Recruiting |
Enrollment | 36 |
Est. completion date | July 31, 2021 |
Est. primary completion date | July 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 85 Years |
Eligibility |
Inclusion Criteria: 1. Patients suffered from chronic unilateral knee pain for more than 4 months and with roentgenogram degenerative findings of grades 3 and 4 on the Kellgren-Lawrence Classification of Osteoarthritis scale (meaning moderate to severe degrees of knee OA) will be recruited. 2. The volume of the SF in the supra-patellar bursa region is enough (at least 2 mm thickness in bursa fluid as measured by ultrasound) to be aspirated via ultrasound guidance. 3. Small volume of SF will be aspirated first and sent for SF analysis. SF showing evidences of crystals suggesting possible gouty arthritis and infection will not be included in this study. 4. Patient has previously received oral NSAIDs and physical modality treatments but WITHOUT any obvious improvements in knee pain and function. The usage of musculoskeletal ultrasound to confirm that the supra-patellar bursa is in communication with the synovial cavity of the knee joint. This is to prevent the aspiration of isolated cystic lesion at the supra-patellar region. Exclusion Criteria: 1. Total obliteration of knee joint as shown on the roentgenogram images. Patient has systemic disorders such as diabetes, rheumatoid arthritis, major axial deviation of the knee joint (varus >5°, valgus >5°), hematological diseases (coagulopathy), severe cardiovascular diseases, infections, and immune-depression. 2. Patients in therapy with anticoagulants, and taking NSAIDs within the 5 days before blood harvest 3. Patients with hemoglobin value of less than 11 g/dl, and platelet counts of less than 150,000/mm3. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Chang Gung Memorial Hospital | Taoyuan |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lequesne knee osteoarthritis questionnaire | Lequesne knee osteoarthritis functional index includes distance, pain, and function. When added, an index score of > 7 indicates the possibility of knee osteoarthritis. The higher the score, the more severeness of knee osteoarthritis. When the index score is less than 7, the possibility of knee osteoarthritis is not high. | About 10 minutes are required to evaluate the score of LeQuesne index. | |
Primary | Two-dimensional electrophoresis (proteomics) | Hundreds of protein spots can be viewed on 2-dimensional electrophoresis gels. The intensity of each spot represents protein concentration. | Two days are required to measure the protein band intensities on the gels. |
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