Clinical trial NCT01891266: Effects of Tourniquet Use on Physical Function and Performance in Primary Total Knee Arthroplasty
Official title: Effects of Tourniquet Use on Physical Function and Performance in Primary Total Knee Arthroplasty: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: The Danish Rheumatism Association
name: Bevica Fonden
First posted: 2013-07-03
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Change in self reported physical function. Assessed with the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire subscale for, Function in Daily Living (ADL).
timeFrame: Endpoint 3 months
Secondary outcomes:
measure: Change in the Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline, 14 days, 3 months (endpoint) and a 6 and 12 months follow up
measure: Global perceived effect (GPE) score
timeFrame: 3 months (endpoint) and a 6 and 12 months follow up
measure: Change in physical performance (battery).
timeFrame: Baseline, 3 and 14 days, 3 months (endpoint) and a 6 months follow up
Other outcomes:
measure: Change in mechanical muscle function
timeFrame: Baseline, 3 and 6 months
measure: Change in 30-sec Maximal Repeated Unilateral Knee Bending
timeFrame: Baseline, 3 and 6 months
measure: Change in Pain
timeFrame: Baseline and 1-14 days
measure: Muscle biopsies
timeFrame: Baseline
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital and University of Southern Denmark
name: Rasmus Lohmann-Jensen, Cand. Scient
role: PRINCIPAL_INVESTIGATOR
affiliation: Odense University Hospital and University of Southern Denmark
name: Søren Overgaard, Professor
role: STUDY_CHAIR
References:
citation: 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.