OsteoarthritisNCT02308410
Effect of Tourniquet Application on Postoperative Functional Outcome Following Total Knee Arthroplasty
An observational study of Osteoarthritis, run by Medicort Sports & Orthopedic Care at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Tourniquet application during surgery
- Type of treatment
- Surgery or procedure
- How many people
- 99 participants
- Where
- 2 sitesNetherlands
- Study dates
- Oct 2013to Apr 2014
- How long will I take part?
- 8 Weeks
- Phase
- Observational
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Scheduled TKA due to osteoarthritis
- Age between 50 and 75 years
- Dutch language proficiency
- Signed informed consent
Who cannot join
- Inflammatory arthritis
- Severe cardiac complaints
- Severe pulmonary disorders
- Body Mass Index >35
- Severe coagulation disorders
- Hospitalization in the previous two months before surgery
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Bergman Clinic Naarden
Naarden, North Holland, 1411 GE
Medicort Sports & Orthopedic Care
Naarden, North Holland, 1411 GE
About this study
Official title: Effect of Tourniquet Application on Postoperative Functional Outcome Following Total Knee Arthroplasty; a Prospective Cohort Study
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.
Read the detailed description
In a prospective cohort design, consecutive series of patients who underwent primary unilateral total knee arthroplasty (TKA) in the Bergman Clinic, the Netherlands were investigated. Patients scheduled for primary TKA due to osteoarthritis, age between 50 and 75 years and with Dutch language proficiency were eligible for inclusion. Exclusion criteria were inflammatory arthritis, severe cardiac complaints, severe pulmonary disorders, Body Mass Index (BMI) >35, severe coagulation disorders or hospitalization in the previous two months before surgery. Each patient included in the study signed informed consent. The research protocol was approved by the Regional Ethics Committee VCMO in Nieuwegein, the Netherlands, registration number W13.022.
- Conditions
- Osteoarthritis
- Being tested
- Tourniquet application during surgery
- Keywords
- Tourniquet, Postoperative outcome, Total knee arthroplasty
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tourniquet application during surgeryProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Tourniquet group | This group received a pneumatic tourniquet during total knee arthroplasty. Receives: Procedure: Tourniquet application during surgery | |
| Non-tourniquet group | This group received no tourniquet during total knee arthroplasty. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (4)
Range of Motion (ROM)
A standard clinical 30cm goniometer was used to evaluated the ROM
Measured: Baseline, day 1, day 2, day 3 and 8 weeks
Isometric bilateral strength
Bilateral isometric strength of the lower limb was measured using hand-held dynamometry (HHD)
Measured: Baseline and 8 weeks
VAS questionnaire.
A 100mm Visual Analogue Scale was used for measuring current, minimal and maximal pain.
Measured: Baseline, day 1, day 2, day 3 and 8 weeks
EQ-5D questionnaire
Quality of life was using the EQ05D questionnaire.
Measured: Baseline, day 1, day 2, day 3 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startOct 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
- Target duration
- 8 Weeks
Sponsor and investigators
- Lead sponsor
- Medicort Sports & Orthopedic Care
- Sponsor type
- University, hospital or other
- Collaborators
- VU University of Amsterdam
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308410
- Sponsor's protocol ID
- Medicort Bergman Tourniquet
- Status last verified
- Dec 2014
- First submitted
- 20 Nov 2014
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24954487
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tourniquet Application on Postoperative Functional Outcome Following Total Knee Arthroplasty; a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02308410
- Acronym / sponsor ID
- Medicort Bergman Tourniquet
- Conditions
- Osteoarthritis
- Keywords
- Tourniquet, Postoperative outcome, Total knee arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Medicort Sports & Orthopedic CareUniversity, hospital or other
- Collaborators
- VU University of Amsterdam
- Study start
- Oct 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 4 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In a prospective cohort design, consecutive series of patients who underwent primary unilateral total knee arthroplasty (TKA) in the Bergman Clinic, the Netherlands were investigated. Patients scheduled for primary TKA due to osteoarthritis, age between 50 and 75 years and with Dutch language proficiency were eligible for inclusion. Exclusion criteria were inflammatory arthritis, severe cardiac complaints, severe pulmonary disorders, Body Mass Index (BMI) >35, severe coagulation disorders or hospitalization in the previous two months before surgery. Each patient included in the study signed informed consent. The research protocol was approved by the Regional Ethics Committee VCMO in Nieuwegein, the Netherlands, registration number W13.022.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tourniquet group | – | Procedure: Tourniquet application during surgeryThis group received a pneumatic tourniquet during total knee arthroplasty. |
| Non-tourniquet group | – | –This group received no tourniquet during total knee arthroplasty. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Scheduled TKA due to osteoarthritis
- Age between 50 and 75 years
- Dutch language proficiency
- Signed informed consent
Key exclusion criteria (6 listed)
- Inflammatory arthritis
- Severe cardiac complaints
- Severe pulmonary disorders
- Body Mass Index >35
- Severe coagulation disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tourniquet application during surgeryBoth 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). | Procedure or surgery | Tourniquet group |
Primary outcome
Knee Injury and Osteoarthritis Score (KOOS) questionnaire
Time frame: 8 weeks
The KOOS questionnaire was used to assess the functional outcome. Changes were evaluated from baseline at 8 weeks.
4 secondary outcomes
Range of Motion (ROM)
Time frame: Baseline, day 1, day 2, day 3 and 8 weeks
Isometric bilateral strength
Time frame: Baseline and 8 weeks
VAS questionnaire.
Time frame: Baseline, day 1, day 2, day 3 and 8 weeks
EQ-5D questionnaire
Time frame: Baseline, day 1, day 2, day 3 and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
- Results publication: PubMed 24954487Ejaz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Medicort Sports & Orthopedic Care at 2 sites in Netherlands.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Knee Injury and Osteoarthritis Score (KOOS) questionnaire (time frame: 8 weeks). 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 NCT02308410, which also lists 1 linked publication.
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 Dec 2014.