Tourniquet vs. no Tourniquet During Total Knee Arthroplasty

NCT ID: NCT02907047

Last Updated: 2019-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2017-10-01

Brief Summary

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The purpose of this study is to correlate functional outcomes and perioperative complications with tourniquet use during total knee arthroplasty.

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Intervention Model

PARALLEL

Study Groups

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Tourniquet

These subjects will have their tourniquet inflated during key portions of the total knee arthroplasty procedure

Group Type ACTIVE_COMPARATOR

tourniquet inflated

Intervention Type OTHER

No tourniquet

These subjects will not have their tourniquet inflated during key portions of the total knee arthroplasty procedure

Group Type OTHER

tourniquet not inflated

Intervention Type OTHER

Interventions

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tourniquet inflated

Intervention Type OTHER

tourniquet not inflated

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. All unilateral primary knee arthroplasties performed by investigators participating in this study will be eligible for inclusion
2. Diagnosis of osteoarthritis

Exclusion Criteria

1. Revision surgery
2. Bilateral knee surgery
3. Age \<18 or \>80
4. BMI \>40
5. Baseline lower extremity strength less than 5/5
6. Vascular calcifications
7. History of chronic narcotic use, defined as more than 5mg of oxycodone q4 hours
8. Functionally limiting spine disease
9. Other functionally limiting lower extremity disorder (i.e. symptomatic ipsilateral hip disease)
10. Patients who cannot perform the baseline functional tests
11. Allergy/contraindication to protocol medications
12. Post-traumatic arthritis
13. Inflammatory arthritis
14. Pregnancy
15. Prisoners
16. Patients receiving care as part of a worker's compensable injury
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rothman Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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16Austin01

Identifier Type: -

Identifier Source: org_study_id

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