AzTrials
AzTrials

Osteoarthritis, KneeNCT03666598

The Effects of a Tourniquet in Total Knee Arthroplasty.

A study testing Tourniquet in people with Osteoarthritis, Knee, run by Norwegian University of Science and Technology at 1 site in Norway.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
Tourniquet
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteNorway
Study dates
28 May 2019to Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Knee osteoarthrosis qualifying for total knee arthroplasty

Who cannot join

  • Coagulation disease
  • Rheumatoid arthritis
  • Peripheral vascular disease
  • Malign disease
  • Pregnancy
  • On-going infection
  • Not able to understand written and oral information in Norwegian

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Orthopaedic department, Trondheim University Hospital

    Trondheim

Other trials in Norway

About this study

Official title: 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.

Being tested
Tourniquet
Keywords
Arthroplasty, Replacement, Knee, Tourniquets, Pain, postoperative, Muscle strength
Medical subject headings
Osteoarthritis, Knee, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TourniquetDevice

    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.

Study groups in NCT03666598
Study groupRoleWhat they receive
No tourniquetNo interventionNo use of tourniquet during surgery
TourniquetExperimentalUse of tourniquet during surgery. The cuff will be inflated to 300mmHg
Receives: Device: Tourniquet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mmax

    EMG recordings are made using 10mm electrodes (Ag-AgCl) attached in a bipolar configuration over the vastus lateralis and rectus femoris

    Measured: 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

  2. Nerve growth factor (NGF)

    Analysis from muscle biopsies harvested from the m. vastus lateralis

    Measured: Change from during surgery to 8 weeks postoperative

  3. 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.

    Measured: Change from 1) preoperative (baseline) to 2) change from preoperative to 8 weeks postoperative, 3) change from preoperative to 1 year postoperative

Secondary outcomes (16)

  1. 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)

    Measured: 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

  2. 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.

    Measured: 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

  3. Rate of force development, voluntary activation and muscle contractility

    Measured: 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

    Body worn activity monitor

    Measured: Change from day 3 - 10 postoperative to 1 year postoperative (1 week measurement)

  5. EuroQual 5D-L

    Patient reported outcome measure

    Measured: Preoperative, 8 weeks, 1 year postoperative

  6. 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.

    Measured: Preoperative, from day 1 postoperative to 4 weeks postoperative, 8 weeks and 1 years postoperative

  7. Hemoglobin values

    g/dL

    Measured: Preoperatively, day 1 postoperative

  8. Volume of bleeding

    Total volume of bleeding during surgery and in the drain

    Measured: During surgery and day 1 postoperative

  9. Length of hospital stay

    Number of days

    Measured: From day of surgery until 10 days postoperative

  10. Knee circumference

    The circumference of the knee is measured 1 cm proximal to the patella base

    Measured: Preoperative and day 1 postoperative

  11. Knee joint range of motion

    Maximal flexion and extension

    Measured: Preoperative, 1 day, 8 weeks,1 year postoperative

  12. Forgotten Joint Score

    Patient reported outcome measure

    Measured: Preoperative, 8 weeks, 1 year postoperative

  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.

    Analysis from muscle biopsies harvested from the vastus lateralis (muscle)

    Measured: Peroperative and 8 weeks postoperative

  14. Neuronal markers; PGP, GAP-43

    Analysis from muscle biopsies harvested from the vastus lateralis (muscle)

    Measured: During surgery and 8 weeks postoperative

  15. Neuromediators; SP, CGRP, glutamate

    Analysis from muscle biopsies harvested from the vastus lateralis (muscle)

    Measured: During surgery and 8 weeks postoperative

  16. Pain receptors; glutamate receptors

    Analysis from muscle biopsies harvested from the vastus lateralis (muscle)

    Measured: During surgery and 8 weeks postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2018
  2. Study start28 May 2019
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03666598
Sponsor's protocol ID
2017/2206
Status last verified
Apr 2022
First submitted
30 Aug 2018
Last updated
4 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Johnsen M, Havik S, Husby VS, Winther SB, Foss OA, Husby OS, Lian OB. The use of tourniquet in total knee arthroplasty does not impact the functional outcome: a randomised controlled study. J Orthop Surg Res. 2024 Oct 30;19(1):704. doi: 10.1186/s13018-024-05203-y.

    PubMed 39478609

  • Johnsen M, Mousavizadeh R, Scott A, Havik S, Husby VS, Winther SB, Husby OS, Lian O. The tourniquet's effects on skeletal muscle during total knee arthroplasty. J Orthop Res. 2024 Sep;42(9):1955-1963. doi: 10.1002/jor.25859. Epub 2024 Apr 21.

    PubMed 38644356

Questions about this trial

What is this clinical trial studying?

A study testing Tourniquet in people with Osteoarthritis, Knee, run by Norwegian University of Science and Technology at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03666598, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in