Condition category
Musculoskeletal Diseases
Date applied
06/04/2020
Date assigned
06/04/2020
Last edited
06/04/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Knee replacement, also known as knee arthroplasty, is a surgical procedure to replace the weight-bearing surfaces of the knee joint to relieve pain and disability. It is most commonly performed for osteoarthritis, and also for other knee diseases such as rheumatoid arthritis and psoriatic arthritis.
Unicompartmental knee arthroplasty (UKA) is a surgical procedure used to relieve arthritis in one of the knee compartments in which the damaged parts of the knee are replaced. UKA surgery may reduce post-operative pain and have a shorter recovery period than a total knee arthroplasty (TKA) procedure.
Utilization of tourniquet is considered to compromise the outcome of knee arthroplasty. This study aims to evaluate the hidden blood loss and function restoration of UKA without tourniquet by comparing with total knee arthroplasty (TKA).

Who can participate?
Adults over 18 years, scheduled to undergo UKA or TKA

What does the study involve?
This study is a retrospective analysis of patient records looking at patients who underwent UKA or TKA without tourniquet.

What are the possible benefits and risks of participating?
None.

Where is the study run from?
Department of Orthopedic Surgery, The First People’s Hospital of Huzhou, Huzhou (China)

When is the study starting and how long is it expected to run for?
August 2017 to December 2019

Who is funding the study?
Department of Orthopedic Surgery, the Second Affiliated Hospital, School of Medicine, Zhejiang University (China)

Who is the main contact?
Dr Zhanfeng Zhang
335980557@qq.com

Trial website

Contact information

Type

Public

Primary contact

Dr Zhanfeng Zhang

ORCID ID

http://orcid.org/0000-0002-1469-4475

Contact details

Department of Orthopedic Surgery
The First People’s Hospital of Huzhou
158 Guangchang Back Rd
Wuxing District
Huzhou
313000
China
+86 15905720901
335980557@163.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

2019035

Study information

Scientific title

Blood loss and knee function after unicompartmental knee arthroplasty (UKA) without tourniquet

Acronym

BLAKFAUKAWT

Study hypothesis

1. UKA or TKA without tourniquet results in lower blood loss compared to with tourniquet.
2. UKA without tourniquet results in less HBL compared with TKA
3. UKA without tourniquet enjoys a better outcome than TKA

Ethics approval

Approved 06/06/2019, Medical Ethics Committee of The First People's Hospital of Huzhou (The First People’s Hospital of Huzhou, 158 Guangchang Back Rd, Wuxing District, Huzhou, 313000, China; +86 (0)572 2508930; hzyyllwyh@163.com), ref: 2019035

Study design

Single-center retrospective controlled study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Osteoarthritis

Intervention

In this retrospective study, patients were included from August 2017 to October 2018. Both the UKA group and the TKA group underwent procedure without the utilization of tourniquet during the whole process.
The gender, age, body mass index, American Society of Anesthesiologists score, Kellgren-Lawrence grade, perioperative Hb, and volume of hidden blood loss (HBL) were recorded and analysed.
Knee function was assessed at 3 months and 12 months after the procedure by using HSS score.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

1. Mean volume of HBL during the procedure (ml)
2. Knee function assessed at 3 months and 12 months after the procedure by HSS score

Secondary outcome measures

Hb level measured using blood test on the 2nd day, 4th day, 6th day, 8th day postoperatively

Overall trial start date

01/06/2017

Overall trial end date

30/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Primary UKA or TKA
2. Kellgren-Lawrence (KL) grade of medial knee osteoarthritis grade Ⅳ

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

56 cases of UKA, and 56 cases of TKA

Total final enrolment

112

Participant exclusion criteria

1. Preoperative abnormality in coagulation function, hematonosis history
2. Postoperative poor general situation
3. More than 2000ml per day in fluid infusion
4. Simultaneous bilateral UKA or TKA, and UKA or TKA secondary to a failed arthroplasty procedure

Recruitment start date

01/08/2017

Recruitment end date

30/10/2018

Locations

Countries of recruitment

China

Trial participating centre

Department of Orthopedic Surgery
The First People’s Hospital of Huzhou 158 Guangchang Back Rd Wuxing District
Huzhou
313000
China

Sponsor information

Organisation

The First People’s Hospital of Huzhou

Sponsor details

158 Guangchang Back Rd
Wuxing District
Huzhou
313000
China
+86 0572 2508930
15905720901@163.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Zhejiang University School of Medicine, Second affiliated hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Intention to publish date

04/08/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/04/2020: Trial’s existence confirmed by Medical Ethics Committee of The First People's Hospital of Huzhou