NCT02102581

Brief Summary

To study the short-term effects of tourniquet use in different ways in total knee arthroplasty,60 patients were randomly divided into 2 groups (30 cases/group): group A using the tourniquet throughout the operation, and group B using the tourniquet starting from the implantation of prosthesis to the completion of the operation. Operation time, total measured blood loss, intraoperative transfusion volume, and complication were recorded. Hemoglobin level was recorded preoperatively and in postoperative 1, 3, 7 and 14 days, and the limb circumference, pain score, and knee joint range of motion were also recorded preoperatively and in postoperative 3,7 and 14 days.Investigators want to observe the difference between the two groups. Hypothesis was made that patients in group B may feel better after operation for short time use of tourniquet.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 3, 2014

Completed
Last Updated

April 3, 2014

Status Verified

March 1, 2014

Enrollment Period

10 months

First QC Date

March 24, 2014

Last Update Submit

March 30, 2014

Conditions

Keywords

TourniquetTotal knee arthroplastyBlood lossLimb swellingLimb circumference

Outcome Measures

Primary Outcomes (1)

  • the limb circumference at 10 cm above the knee at postoperative day 1,3,7 and 14

    14 days after the surgery

Study Arms (1)

short time tourniquet

60 patients were randomly divided into 2 groups (30 cases/group): group A using the tourniquet throughout the operation, and group B using the tourniquet starting from the implantation of prosthesis to the completion of the operation(short time).

Procedure: short time tourniquet

Interventions

short time tourniquet: the tourniquet starting from the implantation of prosthesis to the completion of the operation.

short time tourniquet

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

60 consecutive patients who underwent routine TKA were included in this prospective randomized study.

You may qualify if:

  • Patients eligible for the study included those who underwent initial unilateral TKA for osteoarthritis or rheumatoid arthritis.

You may not qualify if:

  • Patients with diabetes, hemorrhagic disease, Hb \< 100 g/L, peripheral neurovascular disease, malignant tumors, history of vascular thrombosis, or history of infection in the lower limb were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

orthopedic department, Peking Union Medical College Hospital

Beijing, 100730, China

Location

Related Publications (1)

  • Fan Y, Jin J, Sun Z, Li W, Lin J, Weng X, Qiu G. The limited use of a tourniquet during total knee arthroplasty: a randomized controlled trial. Knee. 2014 Dec;21(6):1263-8. doi: 10.1016/j.knee.2014.08.002. Epub 2014 Sep 9.

MeSH Terms

Conditions

OsteoarthritisHemorrhage

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yu Fan, MD

    an orthopaedist of Peing Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
14 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2014

First Posted

April 3, 2014

Study Start

February 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

April 3, 2014

Record last verified: 2014-03

Locations