Osteoarthritis, Knee
Conditions
Keywords
Arthroplasty, Replacement, Knee, Tourniquets, Pain, postoperative, Muscle strength
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.
Interventions
DEVICETourniquet
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.
Sponsors
Zimmer Biomet
University of British Columbia
Karolinska University Hospital
St. Olavs Hospital
Kristiansund Hospital
Norwegian University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| 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) |
| Knee circumference | Preoperative and day 1 postoperative | The circumference of the knee is measured 1 cm proximal to the patella base |
| 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 | — |
Countries
Norway
Outcome results
None listed