NCT04469166

Brief Summary

This study is randomized controlled trial with 5 years follow up and involved 101 patients divided in two groups; group A in which tourniquet was used in total knee arthroplasty while group B in which tourniquet was not used. All these patients were analyzed for the clinical and functional outcome measures.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

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

March 1, 2014

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 13, 2020

Completed
Last Updated

July 13, 2020

Status Verified

July 1, 2020

Enrollment Period

6.1 years

First QC Date

July 3, 2020

Last Update Submit

July 10, 2020

Conditions

Use of Tourniquet in Total Knee Arthroplasty

Keywords

TourniquetTotal knee arthroplastyClinical outcomesFunctional outcomes

Outcome Measures

Primary Outcomes (3)

  • Knee society score

    Knee society score for functional outcome which will be low in poor function and high in best function

    This score was assessed at 5 years postoperatively

  • Knee injury and osteoarthritis outcome scores

    Knee injury and osteoarthritis outcome score which will be low in poor function and high in better function

    This score was assessed at 5 years post-operatively

  • VAS for thigh pain

    Visual analogue scale for thigh pain which will be high in more pain and low in less pain

    This score was assessed at 1st day post-operatively

Secondary Outcomes (1)

  • Post operative complications

    These complications as bleeding, infection, Deep venous thrombosis and revision are assessed at postoperative period.

Study Arms (2)

Tourniquet

ACTIVE COMPARATOR

Group of tourniquet

Procedure: tourniquet

No tourniquet

ACTIVE COMPARATOR

Group of no tourniquet

Procedure: No tourniquet

Interventions

tourniquetPROCEDURE

Use of tourniquet

Tourniquet
No tourniquetPROCEDURE

No use of tourniquet

No tourniquet

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Grade 3 and 4 osteoarthritis
  • age 55-80 years
  • patients agree to participate in the study

You may not qualify if:

  • Smoking
  • Diabetes mellitus .Symptomatic spinal pathology with moderate to severe cervical or lumbosacral spinal stenosis.
  • Hip pathology like osteoarthritis or fractures
  • Neuromuscular disorders
  • Blood dyscrasia or anticoagulant treatment .Body mass index equal to 30 or more.
  • Previous knee surgery or knee infection
  • Peripheral vascular disease
  • Rheumatoid arthritis
  • Hemoglobin less than 12 gram/deciliter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Tourniquets

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blinded study
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of orthopedic surgery

Study Record Dates

First Submitted

July 3, 2020

First Posted

July 13, 2020

Study Start

March 1, 2014

Primary Completion

March 20, 2020

Study Completion

March 30, 2020

Last Updated

July 13, 2020

Record last verified: 2020-07