The Effects of a Tourniquet in Total Knee Arthroplasty.
- Conditions
- Osteoarthritis, Knee
- Interventions
- Device: Tourniquet
- Registration Number
- NCT03666598
- Lead Sponsor
- Norwegian University of Science and Technology
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- Knee osteoarthrosis qualifying for total knee arthroplasty
- Coagulation disease
- Rheumatoid arthritis
- Peripheral vascular disease
- Malign disease
- Pregnancy
- On-going infection
- Not able to understand written and oral information in Norwegian
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tourniquet Tourniquet Use of tourniquet during surgery. The cuff will be inflated to 300mmHg
- Primary Outcome Measures
Name Time Method Mmax Change from 1) preoperative (baseline) to day 2 postoperative, 2) change from preoperative to 8 weeks postoperative, 3) change from preoperative to 1 year postoperative EMG recordings are made using 10mm electrodes (Ag-AgCl) attached in a bipolar configuration over the vastus lateralis and rectus femoris
Nerve growth factor (NGF) Change from during surgery to 8 weeks postoperative Analysis from muscle biopsies harvested from the m. vastus lateralis
Forgotten Joint Score Change from 1) preoperative (baseline) to 2) change from preoperative to 8 weeks postoperative, 3) change from preoperative to 1 year postoperative The stair climbing test measures the time (in seconds) to ascend, turn around and descend a regular stairway of 11 steps. The patients are asked to perform the test as quickly as possible.
- Secondary Outcome Measures
Name Time Method Maximal leg strength Change from 1) preoperative (baseline) to day 2 postoperative, 2) change from preoperative to 8 weeks postoperative, 3) change from preoperative to 1 year postoperative 1RM leg strength is measured using a leg press ergometer with the participant in a supine position (Steens Physical; Ring Mekanikk, Moelv, Norway)
Maximal knee extension strength Change from 1) preoperative (baseline) to day 2 postoperative, 2) change from preoperative to 8 weeks postoperative, 3) change from preoperative to 1 year postoperative 1RM knee extension is measured using a knee extension equipment (Body-Solid, Forest Park, IL, USA) with the participant in a seated position.
Rate of force development, voluntary activation and muscle contractility Change from 1) preoperative (baseline) to day 2 postoperative, 2) change from preoperative to 8 weeks postoperative, 3) change from preoperative to 1 year postoperative Daily physical activity Change from day 3 - 10 postoperative to 1 year postoperative (1 week measurement) Body worn activity monitor
EuroQual 5D-L Preoperative, 8 weeks, 1 year postoperative Patient reported outcome measure
Numeric Rating Scale (NRS) Preoperative, from day 1 postoperative to 4 weeks postoperative, 8 weeks and 1 years postoperative Evaluating pain. The scale range from 0 (no pain) to 10 (worst pain imaginable) (7). The patients are asked to write down NRS values both at rest and during activity each day for the first 4 weeks postoperatively in a home log.
Hemoglobin values Preoperatively, day 1 postoperative g/dL
Volume of bleeding During surgery and day 1 postoperative Total volume of bleeding during surgery and in the drain
Length of hospital stay From day of surgery until 10 days postoperative Number of days
Knee circumference Preoperative and day 1 postoperative The circumference of the knee is measured 1 cm proximal to the patella base
Knee joint range of motion Preoperative, 1 day, 8 weeks,1 year postoperative Maximal flexion and extension
Forgotten Joint Score Preoperative, 8 weeks, 1 year postoperative Patient reported outcome measure
Gene expression analyses. RT-PCR for expression levels for VEGF, NGF, SP, CGRP, IL-6, IL-1, TNF-alpha, Bad, Bax, Bid, Bim, Fas, Fas-ligand, Bcl-2, Mcl, and FLIP. Results will be normalized to GAPDH expression levels. Peroperative and 8 weeks postoperative Analysis from muscle biopsies harvested from the vastus lateralis (muscle)
Neuronal markers; PGP, GAP-43 During surgery and 8 weeks postoperative Analysis from muscle biopsies harvested from the vastus lateralis (muscle)
Neuromediators; SP, CGRP, glutamate During surgery and 8 weeks postoperative Analysis from muscle biopsies harvested from the vastus lateralis (muscle)
Pain receptors; glutamate receptors During surgery and 8 weeks postoperative Analysis from muscle biopsies harvested from the vastus lateralis (muscle)
Trial Locations
- Locations (1)
Orthopaedic department, Trondheim University Hospital
🇳🇴Trondheim, Norway