Blood loss and knee function after unicompartmental knee replacement or total knee replacement surgery
| ISRCTN | ISRCTN85133278 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85133278 |
| Secondary identifying numbers | 2019035 |
- 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
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
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 |
| 335980557@163.com |
Study information
| Study design | Single-center retrospective controlled study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/06/2017 |
| Completion date | 30/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 56 cases of UKA, and 56 cases of TKA |
| 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
158 Guangchang Back Rd
Wuxing District
Huzhou
313000
China
Sponsor information
Hospital/treatment centre
158 Guangchang Back Rd
Wuxing District
Huzhou
313000
China
| Phone | +86 0572 2508930 |
|---|---|
| 15905720901@163.com |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 04/08/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. |
Editorial Notes
06/04/2020: Trial’s existence confirmed by Medical Ethics Committee of The First People's Hospital of Huzhou
