An interventional study of Tourniquet in Osteoarthritis, Knee, sponsored by Norwegian University of Science and Technology. Status unknown at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-04.
Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Treatment
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.
3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.
This study's enrollment of 80 is above the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Norwegian University of Science and Technology is the lead sponsor of 487 studies on the registry; 52 are open to participants now.
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Exclusion Criteria:
No use of tourniquet during surgery
Use of tourniquet during surgery. The cuff will be inflated to 300mmHg
Device: Tourniquet
In the patients randomized to the use of tourniquet, the tourniquet time starts before skin incision and terminates when the wound closure starts. The cuff pressure is set at 300mmHg.
Mmax
EMG recordings are made using 10mm electrodes (Ag-AgCl) attached in a bipolar configuration over the vastus lateralis and rectus femoris
Time frame: 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
Nerve growth factor (NGF)
Analysis from muscle biopsies harvested from the m. vastus lateralis
Time frame: Change from during surgery to 8 weeks postoperative
Forgotten Joint Score
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.
Time frame: Change from 1) preoperative (baseline) to 2) change from preoperative to 8 weeks postoperative, 3) change from preoperative to 1 year postoperative
Maximal leg strength
1RM leg strength is measured using a leg press ergometer with the participant in a supine position (Steens Physical; Ring Mekanikk, Moelv, Norway)
Time frame: 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
Maximal knee extension strength
1RM knee extension is measured using a knee extension equipment (Body-Solid, Forest Park, IL, USA) with the participant in a seated position.
Time frame: 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
Rate of force development, voluntary activation and muscle contractility
Time frame: 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
Body worn activity monitor
Time frame: Change from day 3 - 10 postoperative to 1 year postoperative (1 week measurement)
EuroQual 5D-L
Patient reported outcome measure
Time frame: Preoperative, 8 weeks, 1 year postoperative
Numeric Rating Scale (NRS)
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.
Time frame: Preoperative, from day 1 postoperative to 4 weeks postoperative, 8 weeks and 1 years postoperative
Hemoglobin values
g/dL
Time frame: Preoperatively, day 1 postoperative
Volume of bleeding
Total volume of bleeding during surgery and in the drain
Time frame: During surgery and day 1 postoperative
Length of hospital stay
Number of days
Time frame: From day of surgery until 10 days postoperative
Knee circumference
The circumference of the knee is measured 1 cm proximal to the patella base
Time frame: Preoperative and day 1 postoperative
Knee joint range of motion
Maximal flexion and extension
Time frame: Preoperative, 1 day, 8 weeks,1 year postoperative
Forgotten Joint Score
Patient reported outcome measure
Time frame: Preoperative, 8 weeks, 1 year postoperative
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.
Analysis from muscle biopsies harvested from the vastus lateralis (muscle)
Time frame: Peroperative and 8 weeks postoperative
Neuronal markers; PGP, GAP-43
Analysis from muscle biopsies harvested from the vastus lateralis (muscle)
Time frame: During surgery and 8 weeks postoperative
Neuromediators; SP, CGRP, glutamate
Analysis from muscle biopsies harvested from the vastus lateralis (muscle)
Time frame: During surgery and 8 weeks postoperative
Pain receptors; glutamate receptors
Analysis from muscle biopsies harvested from the vastus lateralis (muscle)
Time frame: During surgery and 8 weeks postoperative
Plan to share: Undecided
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Norwegian University of Science and Technology