Knee OsteoarthritisNCT01891266
Effects of Tourniquet Use on Physical Function and Performance in Primary Total Knee Arthroplasty
A study testing Non-tourniquet assisted TKA and Tourniquet assisted TKA in people with Knee Osteoarthritis, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
Background: Osteoarthritis (OA) is the most common joint disease that causes symptomatic health problems in the elderly population. For some patients with knee OA, total knee arthroplasty (TKA) may be the only option that offers the possibility of reestablishing the patient's life quality. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Non-tourniquet assisted TKA and Tourniquet assisted TKA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2013to Sep 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Knee Osteoarthritis both clinically and radiologically according to the "Ahlbäck classification system".
- Patients who can tolerate spinal anesthesia
Who cannot join
- Patients with rheumatoid arthritis.
- Patients with BMI > 35.
- History of major knee operations.
- Malignancy.
- Known muscle disease.
- History of deep vain thrombosis (DVT), or other blood coagulation disorders.
- Symptomatic bilateral OA, with planned surgery of the contra lateral knee within a year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Tourniquet Use on Physical Function and Performance in Primary Total Knee Arthroplasty: A Randomized Controlled Trial
Background:
Osteoarthritis (OA) is the most common joint disease that causes symptomatic health problems in the elderly population. For some patients with knee OA, total knee arthroplasty (TKA) may be the only option that offers the possibility of reestablishing the patient's life quality.
Read more
Surgery of TKA usually takes place in a complete bloodless field established by a tourniquet around the thigh. The method aims to reduce blood loss and give the surgeon better visibility during the operation. The method is, however, not without side effects as patients often experience severe pain and swollen leg in the time after surgery. Furthermore, has the method shown decidedly muscle- and nerve damage followed by prolonged rehabilitation and reduced physical function.
It is, however, possible to perform the operation without the use of the tourniquet.
Aim and hypothesis:
The aim of the present study is to assess the effects of tourniquet use in TKA on physical function, early rehabilitation, pain and opioid consumption.
Hypotheses H1: TKA without tourniquet leads to better physical function and early rehabilitation.
H2: TKA without tourniquet causes less pain and opioid consumption H3: Recovery of mechanical lower limb function post TKA is faster without use of tourniquet.
Methods:
80 patients (40 in each group) all eligible for TKA will be consecutively recruited and randomized to A) TKA without tourniquet, B) TKA with tourniquet. Subjects will be evaluated before the operation (baseline) and 14 days, 3, 6 and 12 months after the operation.
The primary outcome will be the change from baseline to 3 months in self-administered knee-function (KOOS-ADL subscale). Further, will we examine a number of pre-specified secondary outcomes, which include self-rated knee-related pain, symptoms, difficulty with sports and leisure activities, and quality of life. In addition, muscle function, physical performance, and the use of pain medication will be studied
Impact of the project:
The project design of this study will enable analyses for determining the impact of operating without tourniquet and whether such an intervention can in fact improve physical function, performance and quality of life within TKA patients. The results may impact notably on the patient level and possible redefine current surgical strategies. The societal perspective of the project is to remobilize patients faster, which may reduce hospital services and absence from work.
- Conditions
- Knee Osteoarthritis
- Being tested
- Non-tourniquet assisted TKA, Tourniquet assisted TKA
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-tourniquet assisted TKAProcedure or surgery
The intervention group will undergo non-tourniquet assisted total knee arthroplasty, which means that blood flow to the lower limb is maintained throughout surgery.
Tourniquet assisted TKAProcedure or surgery
The procedure involves the use of a tourniquet around the thigh. During surgery the tourniquet will be inflated above the systolic blood pressure to ensure a complete bloodless surgical field.
| Study group | Role | What they receive |
|---|---|---|
| Non-tourniquet assisted TKA | Experimental | Not described Receives: Procedure: Non-tourniquet assisted TKA |
| Tourniquet assisted TKA | Other | Not described Receives: Procedure: Tourniquet assisted TKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self reported physical function. Assessed with the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire subscale for, Function in Daily Living (ADL).
Further assessments: Baseline, 14 days and a 6 and 12 months follow up. KOOS is a patient-reported outcome measure with good evidence of reliability, validity and responsiveness in different population with varying pathologies, injury durations, and activity levels (http://www.koos.nu).
Measured: Endpoint 3 months
Secondary outcomes (3)
Change in the Knee injury and Osteoarthritis Outcome Score (KOOS)
The remaining 4 subscales for pain, other symptoms, function in sport and recreation, and knee related quality of life.
Measured: Baseline, 14 days, 3 months (endpoint) and a 6 and 12 months follow up
Global perceived effect (GPE) score
In addition to pain and physical function the assessment by the patient of a global perceived effect of the treatment is a recommended responder criterion [4]. Patients will be asked to rate possible change in their condition since the initial administration (baseline) on a 7-point Likert-scale.
Measured: 3 months (endpoint) and a 6 and 12 months follow up
Change in physical performance (battery).
Physical performance-based measures will include; Passive knee range of motion, 30 s chair stand (number completed), 20 m normal-paced and fast-paced walk (time in sec.), and timed up and go (time in sec.)
Measured: Baseline, 3 and 14 days, 3 months (endpoint) and a 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2014 (estimated)
- Study completionSep 2016 (estimated)
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 Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Rheumatism Association, Bevica Fonden
- Responsible party
- Principal investigator, Rasmus Lohmann-Jensen, MSc, University of Southern Denmark
- Investigators
- Rasmus Lohmann-Jensen, Cand. Scient, Principal investigator, Odense University Hospital and University of Southern DenmarkSøren Overgaard, Professor, Study chair, Odense University Hospital and University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891266
- Sponsor's protocol ID
- S-20110084
- Status last verified
- Jun 2013
- First submitted
- 21 Jun 2013
- Last updated
- 3 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Lohmann-Jensen R, Holsgaard-Larsen A, Emmeluth C, Overgaard S, Jensen C. The efficacy of tourniquet assisted total knee arthroplasty on patient-reported and performance-based physical function: a randomized controlled trial protocol. BMC Musculoskelet Disord. 2014 Mar 29;15:110. doi: 10.1186/1471-2474-15-110.
PubMed 24678741
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tourniquet Use on Physical Function and Performance in Primary Total Knee Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01891266
- Acronym / sponsor ID
- S-20110084
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- The Danish Rheumatism Association, Bevica Fonden
- Study start
- Sep 2013
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 3 Jul 2013 (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.
Background:
Osteoarthritis (OA) is the most common joint disease that causes symptomatic health problems in the elderly population. For some patients with knee OA, total knee arthroplasty (TKA) may be the only option that offers the possibility of reestablishing the patient's life quality.
Surgery of TKA usually takes place in a complete bloodless field established by a tourniquet around the thigh. The method aims to reduce blood loss and give the surgeon better visibility during the operation. The method is, however, not without side effects as patients often experience severe pain and swollen leg in the time after surgery. Furthermore, has the method shown decidedly muscle- and nerve damage followed by prolonged rehabilitation and reduced physical function.
It is, however, possible to perform the operation without the use of the tourniquet.
Aim and hypothesis:
The aim of the present study is to assess the effects of tourniquet use in TKA on physical function, early rehabilitation, pain and opioid consumption.
Hypotheses H1: TKA without tourniquet leads to better physical function and early rehabilitation.
H2: TKA without tourniquet causes less pain and opioid consumption H3: Recovery of mechanical lower limb function post TKA is faster without use of tourniquet.
Methods:
80 patients (40 in each group) all eligible for TKA will be consecutively recruited and randomized to A) TKA without tourniquet, B) TKA with tourniquet. Subjects will be evaluated before the operation (baseline) and 14 days, 3, 6 and 12 months after the operation.
The primary outcome will be the change from baseline to 3 months in self-administered knee-function (KOOS-ADL subscale). Further, will we examine a number of pre-specified secondary outcomes, which include self-rated knee-related pain, symptoms, difficulty with sports and leisure activities, and quality of life. In addition, muscle function, physical performance, and the use of pain medication will be studied
Impact of the project:
The project design of this study will enable analyses for determining the impact of operating without tourniquet and whether such an intervention can in fact improve physical function, performance and quality of life within TKA patients. The results may impact notably on the patient level and possible redefine current surgical strategies. The societal perspective of the project is to remobilize patients faster, which may reduce hospital services and absence from work.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-tourniquet assisted TKA | Experimental | Procedure: Non-tourniquet assisted TKA |
| Tourniquet assisted TKA | Other | Procedure: Tourniquet assisted TKA |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Knee Osteoarthritis both clinically and radiologically according to the "Ahlbäck classification system".
- Patients who can tolerate spinal anesthesia
Key exclusion criteria (7 listed)
- Patients with rheumatoid arthritis.
- Patients with BMI > 35.
- History of major knee operations.
- Malignancy.
- Known muscle disease.
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 |
|---|---|---|
| Non-tourniquet assisted TKAThe intervention group will undergo non-tourniquet assisted total knee arthroplasty, which means that blood flow to the lower limb is maintained throughout surgery. | Procedure or surgery | Non-tourniquet assisted TKA |
| Tourniquet assisted TKAThe procedure involves the use of a tourniquet around the thigh. During surgery the tourniquet will be inflated above the systolic blood pressure to ensure a complete bloodless surgical field. | Procedure or surgery | Tourniquet assisted TKA |
Primary outcome
Change in self reported physical function. Assessed with the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire subscale for, Function in Daily Living (ADL).
Time frame: Endpoint 3 months
Further assessments: Baseline, 14 days and a 6 and 12 months follow up. KOOS is a patient-reported outcome measure with good evidence of reliability, validity and responsiveness in different population with varying pathologies, injury durations, and activity levels (http://www.koos.nu).
3 secondary outcomes
Change in the Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline, 14 days, 3 months (endpoint) and a 6 and 12 months follow up
Global perceived effect (GPE) score
Time frame: 3 months (endpoint) and a 6 and 12 months follow up
Change in physical performance (battery).
Time frame: Baseline, 3 and 14 days, 3 months (endpoint) and a 6 months follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2013.
- Derived from this study: PubMed 24678741Lohmann-Jensen R, Holsgaard-Larsen A, Emmeluth C, Overgaard S, Jensen C. The efficacy of tourniquet assisted total knee arthroplasty on patient-reported and performance-based physical function: a randomized controlled trial protocol. BMC Musculoskelet Disord. 2014 Mar 29;15:110. doi: 10.1186/1471-2474-15-110.
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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.
Rasmus Lohmann-Jensen, Cand. Scient principal investigator
Odense University Hospital and University of Southern Denmark
Søren Overgaard, Professor study chair
Odense University Hospital and University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-tourniquet assisted TKA and Tourniquet assisted TKA in people with Knee Osteoarthritis, run by University of Southern Denmark at 1 site in Denmark.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rasmus Lohmann-Jensen, MSc (+45 22407697, rlohmann-jensen@health.sdu.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self reported physical function. Assessed with the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire subscale for, Function in Daily Living (ADL). (time frame: Endpoint 3 months). 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 NCT01891266, 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 3 Jul 2013.