Prospective

Lai Yan CHOW

Room 04, 4/F, Lek Yuen Health Centre, 9 Lek Yuen Street, Shatin, N.T., Hong Kong

9540 3121

chowlyan@cuhk.edu.hk

Division of Family Medicine and Primary Health Care, The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong

Hong Kong

Regina Wing Shan SIT

Room 17A, 4/F, Lek Yuen Health Centre, 9 Lek Yuen Street, Shatin, N.T., Hong Kong

2503 9053

reginasit@cuhk.edu.hk

Division of Family Medicine and Primary Health Care, The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong

Hong Kong

先導計劃 - 研究富血小板血漿注射治療退化性膝關節炎

Yes

2016-10-14

Joint CUHK-NTEC Clinical Research Ethics Committee

2016.416-T

Procedure

Intra-articular and extra-articular Platelet Rich Plasma injections

Platele Rich Plasma (PRP)

6 ml PRP plus 1 ml of 1% xylocaine (total 7 ml)

single injection

Once

N/A

N/A

N/A

N/A

N/A

1) Age ≥ 45 to ≤ 75 years old

2) Self-reported symptoms consistent with KOA per American College of Rheumatology guidelines

3) Have experienced moderate to severe knee pain for at least 3 months, defined as a score of 3 or more (0-6 ordinal response scale) on the question “What is the average level of your left/right knee pain?”

4) Failed 6 months of usual care

5) Clinical evidence of KOA according to the American College of Rheumatology guidelines

6) Radiographic evidence of KOA with Kellgren Lawerance (KL)

1) Pregnancy

2) On anticoagulation, immunosuppressive or daily opioid therapy;

3) History of collagen tissue or other autoimmune disorders;

4) Hematological diseases

5) Severe cardiovascular diseases

6) Prior or planned total knee replacement of the affected knee

7) Allergy or intolerance to acetaminophen or xylocaine

8) Body mass index (BMI) ≥ 35 kg/m2

9) Co-morbidity severe enough to prevent reliable or safe study participation

10) Subjects who cannot read or write in the Chinese Consent form

11) Interim knee joint infectious arthritis or trauma

12) Hemoglobin level < 11g/dL

13) Platelet concentration < 150,000/mm3

14) Clinical examination suggesting that the patient is not appropriate due to comorbid knee or other conditions.

45

75

Both Male and Female

Not Applicable

Not Applicable

Open label

Single group

2

No