The Effects of a Tourniquet in Total Knee Arthroplasty.

• ClinicalTrials.gov Identifier: NCT03666598
• Recruitment Status: Active, not recruiting
• First Posted: September 12, 2018
• Last Update Posted: September 8, 2021
• Sponsor: Norwegian University of Science and Technology
• 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

Study Description

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual 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: February 2022
• Estimated Study Completion Date: February 2022

Arms and Interventions

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.

Outcome Measures

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)

Eligibility Criteria

• 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

Contacts and Locations

Locations

Norway

Orthopaedic department, Trondheim University Hospital

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

• Study Director: Siri Forsmo, prof; Norwegian University of Science and Technology

More Information

• Responsible Party: Norwegian University of Science and Technology
• ClinicalTrials.gov Identifier: NCT03666598
• Other Study ID Numbers: 2017/2206
• First Posted: September 12, 2018
• Last Update Posted: September 8, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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:

Osteoarthritis, Knee; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases