Blood loss and knee function after unicompartmental knee replacement or total knee replacement surgery

ISRCTN	ISRCTN85133278
DOI	https://doi.org/10.1186/ISRCTN85133278
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	2019035
Sponsor	The First People’s Hospital of Huzhou
Funder	Zhejiang University School of Medicine, Second affiliated hospital

Submission date: 06/04/2020
Registration date: 06/04/2020
Last edited: 06/04/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Zhanfeng Zhang
Public

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

ORCID ID	0000-0002-1469-4475
Phone	+86 15905720901
Email	335980557@163.com

Study information

Primary study design	Observational
Study design	Single-center retrospective controlled study
Secondary study design	Case-control study
Study type	Participant information sheet
Scientific title	Blood loss and knee function after unicompartmental knee arthroplasty (UKA) without tourniquet
Study acronym	BLAKFAUKAWT
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Hb level measured using blood test on the 2nd day, 4th day, 6th day, 8th day postoperatively
Completion date	30/12/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	112
Total final enrolment	112
Key inclusion criteria	1. Primary UKA or TKA 2. Kellgren-Lawrence (KL) grade of medial knee osteoarthritis grade Ⅳ
Key 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
Date of first enrolment	01/08/2017
Date of final enrolment	30/10/2018

Locations

Countries of recruitment

China

Study participating centre

Department of Orthopedic Surgery

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

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

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