Clinical trial NCT03666598: The Effects of a Tourniquet in Total Knee Arthroplasty.
Official title: The Effects of a Tourniquet on Implant Migration and Muscle Strength and Function in Patients Operated With Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Arthroplasty, Replacement, Knee
Tourniquets
Pain, postoperative
Muscle strength
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
name: University of British Columbia
name: Karolinska University Hospital
name: St. Olavs Hospital
name: Kristiansund Hospital
First posted: 2018-09-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mmax
timeFrame: 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
measure: Nerve growth factor (NGF)
timeFrame: Change from during surgery to 8 weeks postoperative
measure: Forgotten Joint Score
timeFrame: Change from 1) preoperative (baseline) to 2) change from preoperative to 8 weeks postoperative, 3) change from preoperative to 1 year postoperative
Secondary outcomes:
measure: Maximal leg strength
timeFrame: 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
measure: Maximal knee extension strength
timeFrame: 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
measure: Rate of force development, voluntary activation and muscle contractility
timeFrame: 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
measure: Daily physical activity
timeFrame: Change from day 3 - 10 postoperative to 1 year postoperative (1 week measurement)
measure: EuroQual 5D-L
timeFrame: Preoperative, 8 weeks, 1 year postoperative
measure: Numeric Rating Scale (NRS)
timeFrame: Preoperative, from day 1 postoperative to 4 weeks postoperative, 8 weeks and 1 years postoperative
measure: Hemoglobin values
timeFrame: Preoperatively, day 1 postoperative
measure: Volume of bleeding
timeFrame: During surgery and day 1 postoperative
measure: Length of hospital stay
timeFrame: From day of surgery until 10 days postoperative
measure: Knee circumference
timeFrame: Preoperative and day 1 postoperative
measure: Knee joint range of motion
timeFrame: Preoperative, 1 day, 8 weeks,1 year postoperative
measure: Forgotten Joint Score
timeFrame: Preoperative, 8 weeks, 1 year postoperative
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.
timeFrame: Peroperative and 8 weeks postoperative
measure: Neuronal markers; PGP, GAP-43
timeFrame: During surgery and 8 weeks postoperative
measure: Neuromediators; SP, CGRP, glutamate
timeFrame: During surgery and 8 weeks postoperative
measure: Pain receptors; glutamate receptors
timeFrame: During surgery and 8 weeks postoperative
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Orthopaedic department, Trondheim University Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Siri Forsmo, prof
role: STUDY_DIRECTOR
References: