The Effects of a Tourniquet in Total Knee Arthroplasty.

Norwegian University of Science and Technology

Status: Unknown

Conditions: Osteoarthritis, Knee

Treatments: Device: Tourniquet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03666598

2017/2206

Details and patient eligibility

About

About 5000 total knee arthroplasties (TKA) are performed annually in Norway. Pain and reduced physical function is present in patients operated with TKA up to a year after surgery and about one of five patients are not satisfied with the outcome from TKA surgery. The use of tourniquet during surgery may also have impact on pain and physical function. Whether TKA surgery should be performed with or without the use of tourniquet, is a much-debated issue in orthopedic surgery today, and there is still no consensus in this field. This study will investigate early muscle strength and power recovery, neuromuscular recordings, neuronal changes and patient reported outcome measures after surgery with tourniquet versus not tourniquet.The findings in this study are expected to have implications for rehabilitation and the outcome of the TKA surgery.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Knee osteoarthrosis qualifying for total knee arthroplasty

Exclusion criteria

• Coagulation disease
• Rheumatoid arthritis
• Peripheral vascular disease
• Malign disease
• Pregnancy
• On-going infection
• Not able to understand written and oral information in Norwegian

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

No tourniquet

No Intervention group

Description:

No use of tourniquet during surgery

Tourniquet

Experimental group

Description:

Use of tourniquet during surgery. The cuff will be inflated to 300mmHg

Treatment:

Device: Tourniquet