Total Knee Arthroplasty With and Without Tourniquet: Comparative Study

NCT04130009 | Completed

• 1 other identifier: HMU/Sherwan4
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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

Conditions

Total Knee Arthroplasty

Keywords

Thigh pain; Total knee Arthroplasty; Tourniquet

Outcome Measures

Primary Outcomes (1)

• Visual Analogue score for thigh pain

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

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

Study Arms (2)

TKA with tourniquet

ACTIVE COMPARATOR

This group was treated by TKA with the use of tourniquet

Procedure: Tourniquet use

TKA without tourniquet

ACTIVE COMPARATOR

This group was treated by TKA without tourniquet

Procedure: Tourniquet use

Interventions

Tourniquet use PROCEDURE

Use of Tourniquet in The TKA

Also known as: No tourniquet use

TKA with tourniquet; TKA without tourniquet

Eligibility Criteria

• Age: 48 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Hb less than 12.
• D.M.,Blood dyscrasia.
• Any evidence of infection by screening test ESR and CRP. ,
• BMI more than 30.

Sponsors & Collaborators

• Hawler Medical University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of orthopedic surgery

Model Details: This is comparative study between two groups one treated by Total knee with tourniquet and other group without tourniquet

Study Record Dates

• First Submitted: October 13, 2019
• First Posted: October 17, 2019
• Study Start: March 1, 2016
• Primary Completion: October 10, 2018
• Study Completion: October 20, 2018
• Last Updated: October 17, 2019

Record last verified: 2019-10