The Effects of a Tourniquet in Total Knee Arthroplasty.

NCT03666598 | Unknown DMC

• 1 other identifier: 2017/2206
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

Arthroplasty, Replacement, Knee; Tourniquets; Pain, postoperative; Muscle strength

Outcome Measures

Primary Outcomes (3)

• Mmax

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

  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

• Nerve growth factor (NGF)

  Analysis from muscle biopsies harvested from the m. vastus lateralis

  Change from during surgery to 8 weeks postoperative

• 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.

  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)

• 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

• 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

• 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

• Daily physical activity

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

• EuroQual 5D-L

  Preoperative, 8 weeks, 1 year postoperative

Study Arms (2)

No tourniquet

NO INTERVENTION

No use of tourniquet during surgery

Tourniquet

EXPERIMENTAL

Use of tourniquet during surgery. The cuff will be inflated to 300mmHg

Device: Tourniquet

Interventions

Tourniquet DEVICE

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.

Tourniquet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Knee osteoarthrosis qualifying for total knee arthroplasty

You may not qualify if:

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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• Zimmer Biomet: collaborator
• University of British Columbia: collaborator
• Karolinska University Hospital: collaborator
• St. Olavs Hospital: collaborator
• Kristiansund Hospital: collaborator

Study Sites (1)

Orthopaedic department, Trondheim University Hospital

Trondheim, Norway

Location

Related Publications (1)

• 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.

  PMID: 39478609 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain, Postoperative

Interventions

Tourniquets

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Siri Forsmo, prof

  Norwegian University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 12, 2018
• Study Start: May 28, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 4, 2022

Record last verified: 2022-04

Locations

NO (1)