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

Effects of Tourniquet Use on Physical Function and Performance in Primary Total Knee Arthroplasty: A Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: Non-tourniquet assisted TKA; Procedure: Tourniquet assisted TKA

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self reported physical function. Assessed with the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire subscale for, Function in Daily Living (ADL).	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).	Endpoint 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Knee injury and Osteoarthritis Outcome Score (KOOS)	The remaining 4 subscales for pain, other symptoms, function in sport and recreation, and knee related quality of life.	Baseline, 14 days, 3 months (endpoint) and a 6 and 12 months follow up
Global perceived effect (GPE) score	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.	3 months (endpoint) and a 6 and 12 months follow up
Change in physical performance (battery).	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.)	Baseline, 3 and 14 days, 3 months (endpoint) and a 6 months follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mechanical muscle function	Mechanical muscle function includes; Quadriceps strength (MVC), Rate of force development, surface electromyography, force steadiness.	Baseline, 3 and 6 months
Change in 30-sec Maximal Repeated Unilateral Knee Bending	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.	Baseline, 3 and 6 months
Change in Pain	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.	Baseline and 1-14 days
Muscle biopsies	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.	Baseline

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: Bevica Fonden; The Danish Rheumatism Association
• 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

Publications and helpful links

General Publications

• Lohmann-Jensen R, Holsgaard-Larsen A, Emmeluth C, Overgaard S, Jensen C. The efficacy of tourniquet assisted total knee arthroplasty on patient-reported and performance-based physical function: a randomized controlled trial protocol. BMC Musculoskelet Disord. 2014 Mar 29;15:110. doi: 10.1186/1471-2474-15-110.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ANTICIPATED): November 1, 2014
• Study Completion (ANTICIPATED): September 1, 2016

Study Registration Dates

• First Submitted: June 21, 2013
• First Submitted That Met QC Criteria: June 27, 2013
• First Posted (ESTIMATE): July 3, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): July 3, 2013
• Last Update Submitted That Met QC Criteria: June 27, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: S-20110084