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Clinical Trials/NCT04130009
NCT04130009CompletedNot Applicable

Total Knee Arthroplasty With and Without Tourniquet: Comparative Study

Hawler Medical University0 sites70 target enrollmentStarted: March 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
70
Primary Endpoint
Visual Analogue score for thigh pain

Study Overview

Brief Summary

Tourniquet use during total knee arthroplasty (TKA) improves visibility and reduces intraoperative blood loss. However, tourniquet use may also have a negative impact on early recovery of muscle strength and lower extremity function after TKA.Seventy Patients are involved in this study and were divided into two groups; Group A (35) patients were treated with TKA with pneumatic thigh tourniquet. Group B (35) patients were treated with TKA without tourniquet. All patients were suffering from severe knee osteoarthritis and they failed to respond to conservative treatment so they are candidates for primary TKA. The two groups are matched related to age and gender. Selection of patients into two groups done randomly with regard of odd number for group A and even number for group B

Detailed Description

This study started on March 2016 and ends on October 2018. Seventy Patients are involved in this study and were divided into two groups; Group A (35) patients were treated with TKA with pneumatic thigh tourniquet. Group B (35) patients were treated with TKA without tourniquet. All patients were suffering from severe knee osteoarthritis and they failed to respond to conservative treatment so they are candidates for primary TKA. The two groups are matched related to age and gender. Selection of patients into two groups done randomly with regard of odd number for group A and even number for group B. All patients were followed for a period of two weeks until removal of skin sutures for the following parameters:

Amount of blood transfusion done at and after surgery. Amount of blood drained postoperatively through suction drain. Occurrence of postoperative wound hematoma. VAS (Visual analogue score) for thigh pain at 1st day and (2) weeks postoperatively.

Clinical DVT.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
48 Years to 82 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • patients were suffering from severe knee osteoarthritis and they failed to respond to conservative treatment

Exclusion Criteria

  • Hb less than
  • D.M.,Blood dyscrasia.
  • Any evidence of infection by screening test ESR and CRP. ,
  • BMI more than 30.

Arms & Interventions

TKA with tourniquet

Active Comparator

This group was treated by TKA with the use of tourniquet

Intervention: Tourniquet use (Procedure)

TKA without tourniquet

Active Comparator

This group was treated by TKA without tourniquet

Intervention: Tourniquet use (Procedure)

Outcomes

Primary Outcomes

Visual Analogue score for thigh pain

Time Frame: The VAS for thigh pain was measured in the day 14 after operation

This is measurement of the degree of thigh pain after operation which range from zero to 10

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sherwan Ahmed Ali Hamawandi

assistant professor of orthopedic surgery

Hawler Medical University

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