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Evaluation of Short-term Effects of Tourniquet Use in Different Ways During Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT02102581
Recruitment Status : Completed
First Posted : April 3, 2014
Last Update Posted : April 3, 2014
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

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.

Condition or disease Intervention/treatment
Osteoarthritis Procedure: short time tourniquet

Detailed Description:

Objective: To study the short-term effects of tourniquet use in different ways in total knee arthroplasty.

Methods: 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.


Study Type : Observational [Patient Registry]
Actual Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 14 Days
Official Title: Evaluation of Short-term Effects of Tourniquet Use in Different Ways During Total Knee Arthroplasty: a Randomized Controlled Trial
Study Start Date : February 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Group/Cohort Intervention/treatment
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
short time tourniquet: the tourniquet starting from the implantation of prosthesis to the completion of the operation.



Primary Outcome Measures :
  1. the limb circumference at 10 cm above the knee at postoperative day 1,3,7 and 14 [ Time Frame: 14 days after the surgery ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
60 consecutive patients who underwent routine TKA were included in this prospective randomized study.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102581


Locations
China
orthopedic department, Peking Union Medical College Hospital
Beijing, China, 100730
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Principal Investigator: Yu Fan, MD an orthopaedist of Peing Union Medical College Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02102581     History of Changes
Other Study ID Numbers: Orthopedic deparment
First Posted: April 3, 2014    Key Record Dates
Last Update Posted: April 3, 2014
Last Verified: March 2014

Keywords provided by Peking Union Medical College Hospital:
Tourniquet
Total knee arthroplasty
Blood loss
Limb swelling
Limb circumference

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases