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Clinical Trials/NCT02308410
NCT02308410
Completed
Not Applicable

Effect of Tourniquet Application on Postoperative Functional Outcome Following Total Knee Arthroplasty; a Prospective Cohort Study

Medicort Sports & Orthopedic Care2 sites in 1 country99 target enrollmentOctober 2013
ConditionsOsteoarthritis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
Medicort Sports & Orthopedic Care
Enrollment
99
Locations
2
Primary Endpoint
Knee Injury and Osteoarthritis Score (KOOS) questionnaire
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
April 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Medicort Sports & Orthopedic Care
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Knee Injury and Osteoarthritis Score (KOOS) questionnaire

Time Frame: 8 weeks

The KOOS questionnaire was used to assess the functional outcome. Changes were evaluated from baseline at 8 weeks.

Secondary Outcomes

  • Range of Motion (ROM)(Baseline, day 1, day 2, day 3 and 8 weeks)
  • Isometric bilateral strength(Baseline and 8 weeks)
  • VAS questionnaire.(Baseline, day 1, day 2, day 3 and 8 weeks)
  • EQ-5D questionnaire(Baseline, day 1, day 2, day 3 and 8 weeks)

Study Sites (2)

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