Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00546

2 Trial Registration Date

2017-02-09

i Registration Status

Prospective

3 Secondary IDs

CREC 2016.416-T

4 Source(s) of Funding

N.A

5 Primary Sponsor

Professor Regina Wing Shan SIT

6 Secondary Sponsor

N/A

Function

Take on all the responsibilities of sponsorship jointly with the primary sponsor

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Lai Yan CHOW

ii Address

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

iii Phone

9540 3121

iv Email

chowlyan@cuhk.edu.hk

v Affiliation

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

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Regina Wing Shan SIT

ii Address

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

iii Phone

2503 9053

iv Email

reginasit@cuhk.edu.hk

v Affiliation

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

vi Country

Hong Kong

9 Official Scientific Title of the Study

Intra-articular and extra-articular Platelet Rich Plasma injections for knee osteoarthritis: a pilot single arm feasibility study

10 Public Title

Intra-articular and extra-articular Platelet Rich Plasma injections for knee osteoarthritis: a pilot single arm feasibility study

i Public Title in Chinese 研究名稱

先導計劃 - 研究富血小板血漿注射治療退化性膝關節炎

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2016-10-14

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2016.416-T

14 Medical Condition Being Studied

Knee Osteoarthritis

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Intra-articular and extra-articular Platelet Rich Plasma injections

iii Dosage form of the intervention

Platele Rich Plasma (PRP)

iv Dosage of the intervention

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

v Duration of the intervention

single injection

vi Frequency of the intervention

Once

16 Comparative Treatments

i Description/ name of comparative treatments

N/A

ii Dosage form of the comparative treatments

N/A

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

N/A

v Frequency of the comparative treatments

N/A

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

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)

ii Exclusion Criteria

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.

iii Age Minimum

45

iv Age Maximum

75

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

2

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2017-02-16

21 Target Sample Size

12

22 Recruitment Status

Complete

23 Primary Outcome

i The Name of the outcome

Feasibility measurements

ii The metric or method of measurement used

Test of Injection protocol, Recruitment rate,Retention rate, Adherence rate, Dropout rate, Time spend on the procedure

iii The timepoint(s) of primary interest

Baseline,16 and 26 weeks

Primary Outcome

i The Name of the outcome

Safety of the intervention

ii The metric or method of measurement used

Reported side effects and the number of adverse events as a result of the intervention

iii The timepoint(s) of primary interest

16 and 26 weeks

24 Secondary Outcome

i The Name of the outcome

Objective functional outcomes

ii The metric or method of measurement used

30 second Chair test, 40 meter fast paced walk test, Timed up and go test

iii The timepoint(s) of primary interest

Baseline 16 and 26 weeks

Secondary Outcome

i The Name of the outcome

Self-reported knee-specific pain, function and stiffness

ii The metric or method of measurement used

Western Ontario McMaster University Osteoarthritis Index (WOMAC)

iii The timepoint(s) of primary interest

Baseline, 16 weeks and 26 weeks

Secondary Outcome

i The Name of the outcome

Health-related quality of life

ii The metric or method of measurement used

EuroQuol-5 questionnaire

iii The timepoint(s) of primary interest

Baseline, 16 weeks and 26 weeks

Secondary Outcome

i The Name of the outcome

Treatment satisfaction

ii The metric or method of measurement used

Qeustion:“Will you recommend the therapy to others with knee OA like yours? (yes/no)”.

iii The timepoint(s) of primary interest

at 26 weeks

Secondary Outcome

i The Name of the outcome

Analgesics consumption

ii The metric or method of measurement used

7 days recall of analgesics consumption

iii The timepoint(s) of primary interest

at 26 weeks

Secondary Outcome

i The Name of the outcome

Acute and Constant Knee Pain Severity

ii The metric or method of measurement used

The Intermittent and Constant Osteoarthritis and Pain (ICOAP)

iii The timepoint(s) of primary interest

Basline, 16 and 26 weeks

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2017-12-01

27 Primary Registry and Trial Identifying Number

ChiCTR-OIC-17010625

28 Date of Registration in Primary Registry

Back History

Trial Detail