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The Effects of a Tourniquet in Total Knee Arthroplasty.

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ClinicalTrials.gov Identifier: NCT03666598
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : August 21, 2019
Sponsor:
Collaborators:
Zimmer Biomet
University of British Columbia
Karolinska University Hospital
St Olavs Hospital University Hospital in Trondheim
Kristiansund Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Device: Tourniquet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of a Tourniquet on Implant Migration and Muscle Strength and Function in Patients Operated With Total Knee Arthroplasty
Actual Study Start Date : May 28, 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

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.




Primary Outcome Measures :
  1. Mmax [ 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 ]
    EMG recordings are made using 10mm electrodes (Ag-AgCl) attached in a bipolar configuration over the vastus lateralis and rectus femoris

  2. Nerve growth factor (NGF) [ Time Frame: Change from during surgery to 8 weeks postoperative ]
    Analysis from muscle biopsies harvested from the m. vastus lateralis

  3. Forgotten Joint Score [ Time Frame: 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 Outcome Measures :
  1. Maximal leg strength [ 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 ]
    1RM leg strength is measured using a leg press ergometer with the participant in a supine position (Steens Physical; Ring Mekanikk, Moelv, Norway)

  2. Maximal knee extension strength [ 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 ]
    1RM knee extension is measured using a knee extension equipment (Body-Solid, Forest Park, IL, USA) with the participant in a seated position.

  3. 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 ]
  4. Daily physical activity [ Time Frame: Cange from day 3 - 10 postoperative to 1 year postoperative (1 week measurement) ]
    Body worn activity monitor

  5. EuroQual 5D-L [ Time Frame: Preoperative, 8 weeks, 1 year postoperative ]
    Patient reported outcome measure

  6. Numeric Rating Scale (NRS) [ Time Frame: 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.

  7. Hemoglobin values [ Time Frame: Preoperatively, day 1 postoperative ]
    g/dL

  8. Volume of bleeding [ Time Frame: During surgery and day 1 postoperative ]
    Total volume of bleeding during surgery and in the drain

  9. Length of hospital stay [ Time Frame: From day of surgery until 10 days postoperative ]
    Number of days

  10. Knee circumference [ Time Frame: Preoperative and day 1 postoperative ]
    The circumference of the knee is measured 1 cm proximal to the patella base

  11. Knee joint range of motion [ Time Frame: Preoperative, 1 day, 8 weeks,1 year postoperative ]
    Maximal flexion and extension

  12. Forgotten Joint Score [ Time Frame: Preoperative, 8 weeks, 1 year postoperative ]
    Patient reported outcome measure

  13. 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. [ Time Frame: Peroperative and 8 weeks postoperative ]
    Analysis from muscle biopsies harvested from the vastus lateralis (muscle)

  14. Neuronal markers; PGP, GAP-43 [ Time Frame: During surgery and 8 weeks postoperative ]
    Analysis from muscle biopsies harvested from the vastus lateralis (muscle)

  15. Neuromediators; SP, CGRP, glutamat [ Time Frame: During surgery and 8 weeks postoperative ]
    Analysis from muscle biopsies harvested from the vastus lateralis (muscle)

  16. Pain receptors; glutamate receptors [ Time Frame: During surgery and 8 weeks postoperative ]
    Analysis from muscle biopsies harvested from the vastus lateralis (muscle)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03666598


Contacts
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Contact: Vigdis Schnell Husby, phd +47 73412312 vigdis.schnell.husby@ntnu.no
Contact: Siri Bjørgen Winther, phd +47 72573669 siri.bjorgen@ntnu.no

Locations
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Norway
Orthopaedic department, Trondheim University Hospital Recruiting
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
Zimmer Biomet
University of British Columbia
Karolinska University Hospital
St Olavs Hospital University Hospital in Trondheim
Kristiansund Hospital
Investigators
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Study Director: Siri Forsmo, prof Norwegian University of Science and Technology

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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT03666598     History of Changes
Other Study ID Numbers: 2017/2206
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norwegian University of Science and Technology:
Arthroplasty, Replacement, Knee
Tourniquets
Pain, postoperative
Muscle strength
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases