The Effects of a Tourniquet in Total Knee Arthroplasty.

Osteoarthritis, Knee Clinical Trial

Official title:

The Effects of a Tourniquet on Implant Migration and Muscle Strength and Function in Patients Operated With Total Knee Arthroplasty

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03666598
• Other study ID #: 2017/2206
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 28, 2019
• Est. completion date: December 2022

Study information

• Verified date: April 2022
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
Norway	Orthopaedic department, Trondheim University Hospital	Trondheim

Sponsors (6)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Karolinska University Hospital, Kristiansund Hospital, St Olavs Hospital University Hospital in Trondheim, University of British Columbia, Zimmer Biomet

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mmax	EMG recordings are made using 10mm electrodes (Ag-AgCl) attached in a bipolar configuration over the vastus lateralis and rectus femoris	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
Primary	Nerve growth factor (NGF)	Analysis from muscle biopsies harvested from the m. vastus lateralis	Change from during surgery to 8 weeks postoperative
Primary	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.	Change from 1) preoperative (baseline) to 2) change from preoperative to 8 weeks postoperative, 3) change from preoperative to 1 year postoperative
Secondary	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)	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
Secondary	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.	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
Secondary	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
Secondary	Daily physical activity	Body worn activity monitor	Change from day 3 - 10 postoperative to 1 year postoperative (1 week measurement)
Secondary	EuroQual 5D-L	Patient reported outcome measure	Preoperative, 8 weeks, 1 year postoperative
Secondary	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.	Preoperative, from day 1 postoperative to 4 weeks postoperative, 8 weeks and 1 years postoperative
Secondary	Hemoglobin values	g/dL	Preoperatively, day 1 postoperative
Secondary	Volume of bleeding	Total volume of bleeding during surgery and in the drain	During surgery and day 1 postoperative
Secondary	Length of hospital stay	Number of days	From day of surgery until 10 days postoperative
Secondary	Knee circumference	The circumference of the knee is measured 1 cm proximal to the patella base	Preoperative and day 1 postoperative
Secondary	Knee joint range of motion	Maximal flexion and extension	Preoperative, 1 day, 8 weeks,1 year postoperative
Secondary	Forgotten Joint Score	Patient reported outcome measure	Preoperative, 8 weeks, 1 year postoperative
Secondary	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)	Peroperative and 8 weeks postoperative
Secondary	Neuronal markers; PGP, GAP-43	Analysis from muscle biopsies harvested from the vastus lateralis (muscle)	During surgery and 8 weeks postoperative
Secondary	Neuromediators; SP, CGRP, glutamate	Analysis from muscle biopsies harvested from the vastus lateralis (muscle)	During surgery and 8 weeks postoperative
Secondary	Pain receptors; glutamate receptors	Analysis from muscle biopsies harvested from the vastus lateralis (muscle)	During surgery and 8 weeks postoperative