Effects of Tourniquet Use on Physical Function and Performance in Primary Total Knee Arthroplasty

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by University of Southern Denmark
Sponsor:
Collaborators:
The Danish Rheumatism Association
Bevica Fonden
Information provided by (Responsible Party):
Rasmus Lohmann-Jensen, MSc, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01891266
First received: June 21, 2013
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

Background:

Osteoarthritis (OA) is the most common joint disease that causes symptomatic health problems in the elderly population. For some patients with knee OA, total knee arthroplasty (TKA) may be the only option that offers the possibility of reestablishing the patient's life quality.

Surgery of TKA usually takes place in a complete bloodless field established by a tourniquet around the thigh. The method aims to reduce blood loss and give the surgeon better visibility during the operation. The method is, however, not without side effects as patients often experience severe pain and swollen leg in the time after surgery. Furthermore, has the method shown decidedly muscle- and nerve damage followed by prolonged rehabilitation and reduced physical function.

It is, however, possible to perform the operation without the use of the tourniquet.

Aim and hypothesis:

The aim of the present study is to assess the effects of tourniquet use in TKA on physical function, early rehabilitation, pain and opioid consumption.

Hypotheses H1: TKA without tourniquet leads to better physical function and early rehabilitation.

H2: TKA without tourniquet causes less pain and opioid consumption H3: Recovery of mechanical lower limb function post TKA is faster without use of tourniquet.

Methods:

80 patients (40 in each group) all eligible for TKA will be consecutively recruited and randomized to A) TKA without tourniquet, B) TKA with tourniquet. Subjects will be evaluated before the operation (baseline) and 14 days, 3, 6 and 12 months after the operation.

The primary outcome will be the change from baseline to 3 months in self-administered knee-function (KOOS-ADL subscale). Further, will we examine a number of pre-specified secondary outcomes, which include self-rated knee-related pain, symptoms, difficulty with sports and leisure activities, and quality of life. In addition, muscle function, physical performance, and the use of pain medication will be studied

Impact of the project:

The project design of this study will enable analyses for determining the impact of operating without tourniquet and whether such an intervention can in fact improve physical function, performance and quality of life within TKA patients. The results may impact notably on the patient level and possible redefine current surgical strategies. The societal perspective of the project is to remobilize patients faster, which may reduce hospital services and absence from work.


Condition Intervention
Knee Osteoarthritis
Procedure: Non-tourniquet assisted TKA
Procedure: Tourniquet assisted TKA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Tourniquet Use on Physical Function and Performance in Primary Total Knee Arthroplasty: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • Change in self reported physical function. Assessed with the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire subscale for, Function in Daily Living (ADL). [ Time Frame: Endpoint 3 months ] [ Designated as safety issue: No ]
    Further assessments: Baseline, 14 days and a 6 and 12 months follow up. KOOS is a patient-reported outcome measure with good evidence of reliability, validity and responsiveness in different population with varying pathologies, injury durations, and activity levels (http://www.koos.nu).


Secondary Outcome Measures:
  • Change in the Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Baseline, 14 days, 3 months (endpoint) and a 6 and 12 months follow up ] [ Designated as safety issue: No ]
    The remaining 4 subscales for pain, other symptoms, function in sport and recreation, and knee related quality of life.

  • Global perceived effect (GPE) score [ Time Frame: 3 months (endpoint) and a 6 and 12 months follow up ] [ Designated as safety issue: No ]
    In addition to pain and physical function the assessment by the patient of a global perceived effect of the treatment is a recommended responder criterion [4]. Patients will be asked to rate possible change in their condition since the initial administration (baseline) on a 7-point Likert-scale.

  • Change in physical performance (battery). [ Time Frame: Baseline, 3 and 14 days, 3 months (endpoint) and a 6 months follow up ] [ Designated as safety issue: No ]
    Physical performance-based measures will include; Passive knee range of motion, 30 s chair stand (number completed), 20 m normal-paced and fast-paced walk (time in sec.), and timed up and go (time in sec.)


Other Outcome Measures:
  • Change in mechanical muscle function [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]
    Mechanical muscle function includes; Quadriceps strength (MVC), Rate of force development, surface electromyography, force steadiness.

  • Change in 30-sec Maximal Repeated Unilateral Knee Bending [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]
    Measures the maximum number of knee bends performed on one leg in 30 seconds and the ability to execute fast stretch shortening cycles over the knee joint.

  • Change in Pain [ Time Frame: Baseline and 1-14 days ] [ Designated as safety issue: No ]

    Self-reported pain: Pain intensity is measured using an 11-step visual analogue scale (VAS) (0 = no pain and 10 = worst possible pain). The VAS has been demonstrated to be reliable and valid in assessing the intensity of musculoskeletal knee pain [5].

    Self-reported use of pain medication: The patient's use of pain medication will be registered.


  • Muscle biopsies [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Two muscle biopsy samples (2 * 100 mg) will be acquired in a subgroup of the patients (2 x 10) during operation. One sample will be collected prior to applying the tourniquet, and a second sample will be collected prior to the removal of the tourniquet. Muscle tissue is frozen in liquid nitrogen and sent for analysis at the Institute of Sports Science and Clinical Biomechanics for mechanical characteristics, Ca2+-kinetics and markers of free oxygen radicals.


Estimated Enrollment: 80
Study Start Date: September 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Non-tourniquet assisted TKA Procedure: Non-tourniquet assisted TKA
The intervention group will undergo non-tourniquet assisted total knee arthroplasty, which means that blood flow to the lower limb is maintained throughout surgery.
Tourniquet assisted TKA Procedure: Tourniquet assisted TKA
The procedure involves the use of a tourniquet around the thigh. During surgery the tourniquet will be inflated above the systolic blood pressure to ensure a complete bloodless surgical field.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Knee Osteoarthritis both clinically and radiologically according to the "Ahlbäck classification system".
  • Patients who can tolerate spinal anesthesia

Exclusion Criteria:

  • Patients with rheumatoid arthritis.
  • Patients with BMI > 35.
  • History of major knee operations.
  • Malignancy.
  • Known muscle disease.
  • History of deep vain thrombosis (DVT), or other blood coagulation disorders.
  • Symptomatic bilateral OA, with planned surgery of the contra lateral knee within a year.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01891266

Contacts
Contact: Rasmus Lohmann-Jensen, MSc +45 22407697 rlohmann-jensen@health.sdu.dk
Contact: Søren Overgaard, Professor +45 65413889 soeren.overgaard@ouh.regionsyddanmark.dk

Locations
Denmark
Odense University Hospital Not yet recruiting
Odense, Denmark, 5000
Sponsors and Collaborators
University of Southern Denmark
The Danish Rheumatism Association
Bevica Fonden
Investigators
Principal Investigator: Rasmus Lohmann-Jensen, Cand. Scient Odense University Hospital and University of Southern Denmark
Study Chair: Søren Overgaard, Professor Odense University Hospital and University of Southern Denmark
  More Information

No publications provided by University of Southern Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rasmus Lohmann-Jensen, MSc, MSc, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01891266     History of Changes
Other Study ID Numbers: S-20110084
Study First Received: June 21, 2013
Last Updated: June 27, 2013
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 23, 2014