Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00470

2 Trial Registration Date

2015-08-20

i Registration Status

Prospective

3 Secondary IDs

2015.101-T

4 Source(s) of Funding

The Chinese University of Hong Kong

5 Primary Sponsor

Prof. Kevin HO Ki Wai

6 Secondary Sponsor

Dr. Tse Lung Fung

Function

Please specify

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

i Name

Jenny ZHANG Jing

ii Address

Department of Orthopaedics and Traumatology, Prince of Wales Hospital, Shatin, Hong Kong

iii Phone

26326553

iv Email

jennyzhang1009@cuhk.edu.hk

v Affiliation

Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong

vi Country

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

i Name

Prof. Kevin HO Ki Wai

ii Address

Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong

iii Phone

26322715

iv Email

kevinho@cuhk.edu.hk

v Affiliation

Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Randomized study comparing arthroscopic debridement and two-stage total joint arthroplasty in patient with septic degenerative joint

10 Public Title

Randomized study comparing arthroscopic debridement and two-stage total joint arthroplasty in patient with septic degenerative joint

i Public Title in Chinese 研究名稱

感染性退化關節炎: 關節清創與兩階段全關節置換手術的比較

11 Short Title (Optional)

N/A

12 Countries of Recruitment

HKSAR

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2015-06-23

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

septic degenerative joint

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

two-stage total joint arthroplasty and arthroscopic debridement or open arthrotomy washout

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

during the operation

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

To compare the effectiveness of two-stage total joint arthroplasty to the current standard management method - arthroscopic debridement or open arthrotomy washout

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion criteria are patients with the following conditions: 1. aged 40 or above; 2. history of knee/hip arthritis pain prior to the development of septic arthritis; 3. Positive microbiology culture; 4. Radiographic evident of OA with a KL grade of III/IV; 5. Evident of subchondral erosion of >2mm; 6. Evident of avascular necrosis

ii Exclusion Criteria

The following patients will be excluded: 1. Patient who are medically not fit for surgery; 2. Patient who are non-ambulatory; 3. Impaired cognitive function; 4.Unable to comply with the rehabilitation

iii Age Minimum

40

iv Age Maximum

100

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2015-10-01

21 Target Sample Size

20

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Functional performance will be assessed by KSS, HHS, VAS and WOMAC at baseline, 3months, 6 months, 12months, and 24months post-oepration;
Laboratory test will be measured at baseline, day 3, day 7, 3 months, and 6 months post-opetation;
Microbiology test will be performed at baseline and 3 months post-operation;
Radiological examination and SF-36 will be assessed at baseline, 3months, 6months, 12months, and 24 months after operation;
Physical examination will be performed at baseline, day 3, day 7, day 14, 1 month, 3 months, 6 months, 12 months, and 24 months after operation.

24 Secondary Outcome

recurrence rate of infection, number of operation done (re-revision for infection), complications of surgery (aseptic prosthesis loosening, spacer integrity and stability), and length of stay in hospital.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2016-04-05

27 Primary Registry and Trial Identifying Number

ChiCTR-IPC-15006943

28 Date of Registration in Primary Registry

2015-08-20

Back History

Trial Detail