The Effects of a Tourniquet in Total Knee Arthroplasty.

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: Tourniquet

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • Orthopaedic department, Trondheim University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: No tourniquet; No use of tourniquet during surgery
EXPERIMENTAL: Tourniquet; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Nerve growth factor (NGF)	Analysis from muscle biopsies harvested from the m. vastus lateralis	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.	Change from 1) preoperative (baseline) to 2) change from preoperative to 8 weeks postoperative, 3) change from preoperative to 1 year postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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	Body worn activity monitor	Change from day 3 - 10 postoperative to 1 year postoperative (1 week measurement)
EuroQual 5D-L	Patient reported outcome measure	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.	Preoperative, from day 1 postoperative to 4 weeks postoperative, 8 weeks and 1 years postoperative
Hemoglobin values	g/dL	Preoperatively, day 1 postoperative
Volume of bleeding	Total volume of bleeding during surgery and in the drain	During surgery and day 1 postoperative
Length of hospital stay	Number of days	From day of surgery until 10 days postoperative
Knee circumference	The circumference of the knee is measured 1 cm proximal to the patella base	Preoperative and day 1 postoperative
Knee joint range of motion	Maximal flexion and extension	Preoperative, 1 day, 8 weeks,1 year postoperative
Forgotten Joint Score	Patient reported outcome measure	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)	Peroperative and 8 weeks postoperative
Neuronal markers; PGP, GAP-43	Analysis from muscle biopsies harvested from the vastus lateralis (muscle)	During surgery and 8 weeks postoperative
Neuromediators; SP, CGRP, glutamate	Analysis from muscle biopsies harvested from the vastus lateralis (muscle)	During surgery and 8 weeks postoperative
Pain receptors; glutamate receptors	Analysis from muscle biopsies harvested from the vastus lateralis (muscle)	During surgery and 8 weeks postoperative

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: Karolinska University Hospital; University of British Columbia; Zimmer Biomet; Kristiansund Hospital; St Olavs Hospital University Hospital in Trondheim
• Investigators: Study Director: Siri Forsmo, prof, Norwegian University of Science and Technology

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 28, 2019
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: September 10, 2018
• First Posted (ACTUAL): September 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 4, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Muscle strength; Pain, postoperative; Tourniquets; Arthroplasty, Replacement, Knee
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 2017/2206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No