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

U

University of Southern Denmark

Status

Unknown

Conditions

Knee Osteoarthritis

Treatments

Procedure: Tourniquet assisted TKA
Procedure: Non-tourniquet assisted TKA

Study type

Interventional

Funder types

Other

Identifiers

NCT01891266
S-20110084

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

80 participants in 2 patient groups

Non-tourniquet assisted TKA
Experimental group
Treatment:
Procedure: Non-tourniquet assisted TKA
Tourniquet assisted TKA
Other group
Treatment:
Procedure: Tourniquet assisted TKA

Trial contacts and locations

1

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Central trial contact

Søren Overgaard, Professor; Rasmus Lohmann-Jensen, MSc

Data sourced from clinicaltrials.gov

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