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Completed

NCT Number: NCT02308410

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

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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bergman Clinic Naarden, Naarden, North Holland, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tourniquet application during surgery

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).

Primary outcomes

  1. 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

  1. Range of Motion (ROM)

    Time frame: Baseline, day 1, day 2, day 3 and 8 weeks

    A standard clinical 30cm goniometer was used to evaluated the ROM

  2. Isometric bilateral strength

    Time frame: Baseline and 8 weeks

    Bilateral isometric strength of the lower limb was measured using hand-held dynamometry (HHD)

  3. VAS questionnaire.

    Time frame: Baseline, day 1, day 2, day 3 and 8 weeks

    A 100mm Visual Analogue Scale was used for measuring current, minimal and maximal pain.

  4. EQ-5D questionnaire

    Time frame: Baseline, day 1, day 2, day 3 and 8 weeks

    Quality of life was using the EQ05D questionnaire.

Other outcomes

  1. Length of Stay (LOS)

    Time frame: Baseline, day 1, day 2 and day 3

    The total length of each the patients in hospital stay was calculated and evaluated for comparison between both groups.

  2. Used analgesics

    Time frame: Baseline, day 1, day 2 and day 3

    During the clinical phase, analgesic use was noted whereas the doses and time interval of each medication was recorded.

Sponsors and collaborators

Lead sponsor

Medicort Sports & Orthopedic Care

Other

Collaborators

  • VU University of Amsterdam

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 4, 2014
Registry last updated
Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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