NCT02308410

Brief Summary

A pneumatic tourniquet is often used during total knee arthroplasty. However, its effect on postoperative outcomes as soft tissue damage resulting in delayed recovery remains unclear. The purpose of the present study was to compare tourniquet use versus non-tourniquet use during total knee arthroplasty for short-term functional recovery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2013

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 4, 2014

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

6 months

First QC Date

November 20, 2014

Last Update Submit

December 2, 2014

Conditions

Osteoarthritis

Keywords

TourniquetPostoperative outcomeTotal knee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Knee Injury and Osteoarthritis Score (KOOS) questionnaire

    The KOOS questionnaire was used to assess the functional outcome. Changes were evaluated from baseline at 8 weeks.

    8 weeks

Secondary Outcomes (4)

  • Range of Motion (ROM)

    Baseline, day 1, day 2, day 3 and 8 weeks

  • Isometric bilateral strength

    Baseline and 8 weeks

  • VAS questionnaire.

    Baseline, day 1, day 2, day 3 and 8 weeks

  • EQ-5D questionnaire

    Baseline, day 1, day 2, day 3 and 8 weeks

Other Outcomes (2)

  • Length of Stay (LOS)

    Baseline, day 1, day 2 and day 3

  • Used analgesics

    Baseline, day 1, day 2 and day 3

Study Arms (2)

Tourniquet group

This group received a pneumatic tourniquet during total knee arthroplasty.

Procedure: Tourniquet application during surgery

Non-tourniquet group

This group received no tourniquet during total knee arthroplasty.

Interventions

Tourniquet application during surgeryPROCEDURE

Both groups received usual care according to the orthopedic surgeons surgical preferences. One group received no tourniquet during surgery (non-tourniquet group) and the other group received a pneumatic tourniquet during surgery (tourniquet-group).

Tourniquet group

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

In a prospective cohort design, consecutive series of patients who underwent primary unilateral total knee arthroplasty in the Bergman Clinic Naarden, the Netherlands were investigated.

You may qualify if:

  • Scheduled TKA due to osteoarthritis
  • Age between 50 and 75 years
  • Dutch language proficiency
  • Signed informed consent

You may not qualify if:

  • Inflammatory arthritis
  • Severe cardiac complaints
  • Severe pulmonary disorders
  • Body Mass Index \>35
  • Severe coagulation disorders
  • Hospitalization in the previous two months before surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bergman Clinic Naarden

Naarden, North Holland, 1411 GE, Netherlands

Location

Medicort Sports & Orthopedic Care

Naarden, North Holland, 1411 GE, Netherlands

Location

Related Publications (1)

  • Ejaz A, Laursen AC, Kappel A, Laursen MB, Jakobsen T, Rasmussen S, Nielsen PT. Faster recovery without the use of a tourniquet in total knee arthroplasty. Acta Orthop. 2014 Aug;85(4):422-6. doi: 10.3109/17453674.2014.931197. Epub 2014 Jun 23.

    PMID: 24954487RESULT

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
8 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2014

First Posted

December 4, 2014

Study Start

October 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

December 4, 2014

Record last verified: 2014-12

Locations

NL(2)