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Effect of Tourniquet Application on Postoperative Functional Outcome Following Total Knee Arthroplasty

NCT ID: NCT02308410

Last Updated: 2014-12-04

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

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-04-30

Brief Summary

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A pneumatic tourniquet is often used during total knee arthroplasty. However, its effect on postoperative outcomes as soft tissue damage resulting in delayed recovery remains unclear. The purpose of the present study was to compare tourniquet use versus non-tourniquet use during total knee arthroplasty for short-term functional recovery.

Detailed Description

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In a prospective cohort design, consecutive series of patients who underwent primary unilateral total knee arthroplasty (TKA) in the Bergman Clinic, the Netherlands were investigated. Patients scheduled for primary TKA due to osteoarthritis, age between 50 and 75 years and with Dutch language proficiency were eligible for inclusion. Exclusion criteria were inflammatory arthritis, severe cardiac complaints, severe pulmonary disorders, Body Mass Index (BMI) \>35, severe coagulation disorders or hospitalization in the previous two months before surgery. Each patient included in the study signed informed consent. The research protocol was approved by the Regional Ethics Committee VCMO in Nieuwegein, the Netherlands, registration number W13.022.

Conditions

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Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Tourniquet group

This group received a pneumatic tourniquet during total knee arthroplasty.

Tourniquet application during surgery

Intervention Type PROCEDURE

Both groups received usual care according to the orthopedic surgeons surgical preferences. One group received no tourniquet during surgery (non-tourniquet group) and the other group received a pneumatic tourniquet during surgery (tourniquet-group).

Non-tourniquet group

This group received no tourniquet during total knee arthroplasty.

No interventions assigned to this group

Interventions

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Tourniquet application during surgery

Both groups received usual care according to the orthopedic surgeons surgical preferences. One group received no tourniquet during surgery (non-tourniquet group) and the other group received a pneumatic tourniquet during surgery (tourniquet-group).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Scheduled TKA due to osteoarthritis
* Age between 50 and 75 years
* Dutch language proficiency
* Signed informed consent

Exclusion Criteria

* Inflammatory arthritis
* Severe cardiac complaints
* Severe pulmonary disorders
* Body Mass Index \>35
* Severe coagulation disorders
* Hospitalization in the previous two months before surgery
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VU University of Amsterdam

OTHER

Sponsor Role collaborator

Medicort Sports & Orthopedic Care

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bergman Clinic Naarden

Naarden, North Holland, Netherlands

Site Status

Medicort Sports & Orthopedic Care

Naarden, North Holland, Netherlands

Site Status

Countries

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Netherlands

References

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Ejaz A, Laursen AC, Kappel A, Laursen MB, Jakobsen T, Rasmussen S, Nielsen PT. Faster recovery without the use of a tourniquet in total knee arthroplasty. Acta Orthop. 2014 Aug;85(4):422-6. doi: 10.3109/17453674.2014.931197. Epub 2014 Jun 23.

Reference Type RESULT
PMID: 24954487 (View on PubMed)

Other Identifiers

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Medicort Bergman Tourniquet

Identifier Type: -

Identifier Source: org_study_id