The Effects of a Tourniquet in Total Knee Arthroplasty.

NCT ID: NCT03666598

Last Updated: 2022-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-28
• Study Completion Date: 2022-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

No tourniquet

No use of tourniquet during surgery

Group Type: NO_INTERVENTION

No interventions assigned to this group

Tourniquet

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

Group Type: EXPERIMENTAL

Tourniquet

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: collaborator

Karolinska University Hospital

OTHER

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Kristiansund Hospital

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Siri Forsmo, prof

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Locations

Orthopaedic department, Trondheim University Hospital

Trondheim, , Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 39478609 (View on PubMed)

Other Identifiers

2017/2206

Identifier Type: -

Identifier Source: org_study_id