Arthropathy of Knee JointNCT01309035
Total Knee Arthroplasty - Accelerated Recovery Without Tourniquet
A study testing Total Knee Arthroplasty in people with Arthropathy of Knee Joint, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial summary
Introduction: Approximately 7000 total knee replacements (TKAs) are done every year. More than 90% of these knee replacements are performed with the use of bone cement. Traditionally, a tourniquet has been, used to reduce the bleeding during surgery, enabling surgeons to perform delicate dissections in a bloodless… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Arthropathy of Knee Joint
- What is being tested?
- Total Knee Arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2011to May 2014
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with symptomatic and radiographic verified knee symptoms, selected for primary unilateral total knee joint replacement (TKR)
- Age 50 and above (not older than 85)
- BMI < 35 and height >160 cm
- No severe cardiovascular conditions
- No previously knee surgery done in the same knee
- Oral and written acceptance
Who cannot join
- Severe obesity
- rheumatic diseases
- Absence of pulse in foot
- Diabetes
- Previous operation in concerning knee
- Lack of informed consent or ability to read / understand Danish
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aalborg University Hospital, Northern Orthopaedic Division, Department of Arthroplasty, Farsoe Clinic
Farsø, Northern Jutland
About this study
Introduction:
Approximately 7000 total knee replacements (TKAs) are done every year. More than 90% of these knee replacements are performed with the use of bone cement. Traditionally, a tourniquet has been, used to reduce the bleeding during surgery, enabling surgeons to perform delicate dissections in a bloodless operative field.
Read more
A tourniquet can be defined as a constricting or compressing device used to control temporarily venous and arterial circulation to an extremity. Pressure is applied circumferentially on the skin and underlying tissues of a limb. This pressure is transferred to the walls of vessels, causing them to become occluded.
It is well known that applying a tourniquet for more than 1 to 2 hours is associated with a number of disadvantages, for instance, severe pain and muscle effects during the first postoperative day, thereby slowing rehabilitation.
Other side effects related to tourniquet use, include pulmonary embolus caused by venous thrombosis and arterial thrombosis as a result of the dislodgement of an arterial plaque. Furthermore, tourniquet-induced hypertension with general anaesthesia, muscle injury, a wide spectrum of neurologic injuries, and tissue changes (Oedema compartment syndrome, post-tourniquet syndrome) have been reported. An important fact is that bleeding affects the quality of binding between bone and cement and thereby fixation of the knee prosthesis? Since the introduction of modern cementing techniques, no previous clinical studies have investigated the advantages or disadvantages of tourniquet use in knee replacement surgery.
Aims/hypothesis of the study:
- To investigate the advantages and disadvantages of tourniquet use, including whether not using a tourniquet reduces pain, facilitates mobilisation and recovery, and shortens length of stay.
- To study whether use of a tourniquet affects leg muscles during and after surgery, as measured by with use of microdialysis to quantify level of ischemia .
- To determine whether prosthesis fixation, measured by RSA, is affected by tourniquet use. Because third generation cements secure prosthesis fixation, the investigators do not expect to find any clinically significant migration (less than 2 mm) 2 years after surgery.
Perspectives:
The investigators hope that the results of our study will improve rehabilitation regimes so that patients will experience less pain after surgery and thus achieve more rapid mobilisation and return to their daily lives.
Read the detailed description
Design
Patients being able to participate in this study all have to fulfill the given inclusion criteria:
- Patients with symptomatic and radiographic verified knee symptoms, selected for primary unilateral total knee joint replacement (TKA)
- Age 50 and above (not older than 85)
- BMI < 35 and height >160 cm
- No severe cardiovascular conditions
- No previously knee surgery done in the same knee
- Oral and written acceptance
A group concerning 2 x 30 patients will be randomized into two groups. Either an intervention group, with absence of tourniquet or a control group with tourniquet. Which group they will belong to, is blinded to patient and surgeon until they reach operation room. The operation will be performed as usual, but with exception of two additional procedures. During operation small spheric tantalum pellets are placed around the prosthesis. Furthermore patients are prepared for microdialysis, which contain placement of 3 catheters: one in each thigh and one subcutaneously in the abdomen.
Microdialysis is a unique technique to monitor the chemistry of the extracellular space in living tissue. It is primarily used for In Vivo determinations of endogenous metabolites, thus serving as an indicator for ischemia.
RSA is precision radiology where the small pellets are visual on x-ray. Using computer a 3D image is created and the pellets serve as markers. These markers will be measured every 6 months showing whether a possible migration of the prosthesis is occurring and thereby indicating a loosening.
Out-patient treatment Patients will among other things be followed by clinical functional scores, registration of analgetica use, conventional X-ray and RSA In the long run the perspective is that surgery concerning knee replacements will be conducted without the use of tourniquet and thereby reducing the pain of the patients without compromising the end result of the operation, namely the fixation of the prosthesis.
Permissions approved by the Regional Committee on Biomedical Research Ethics, Region of Northern Jutland and Danish Data Protection Agency.
- Conditions
- Arthropathy of Knee Joint
- Being tested
- Total Knee Arthroplasty
- Keywords
- Prothesis fixation, Bloodlessness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee ArthroplastyProcedure or surgery
Surgery for OA knee pains
| Study group | Role | What they receive |
|---|---|---|
| With Tourniquet | Active comparator | Total Knee Arthroplasty. Surgery performed during use of a tourniquet. Receives: Procedure: Total Knee Arthroplasty |
| Without Tourniquet | Experimental | Total Knee Arthroplasty. Surgery performed without use of a tourniquet. Receives: Procedure: Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether prosthesis fixation, measured by RSA, is affected by tourniquet use.
To determine whether prosthesis fixation, measured by RSA, is affected by tourniquet use. Because third generation cements secure prosthesis fixation, we do not expect to find any clinically significant migration (less than 2 mm) 2 years after surgery.
Measured: 1.Feb 2011 -1 jan 2013
Secondary outcomes (1)
To investigate the advantages and disadvantages of tourniquet use, including whether not using a tourniquet reduces pain, facilitates mobilisation and recovery, and shortens length of stay.
Measured: 1.feb 2011 - 1.jan 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthropathy of Knee JointStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01309035
- Sponsor's protocol ID
- ON-001-AE
- Status last verified
- Jan 2015
- First submitted
- 14 Jan 2011
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Knee Arthroplasty - Accelerated Recovery Without Tourniquet
- ClinicalTrials.gov ID
- NCT01309035
- Acronym / sponsor ID
- ON-001-AE
- Conditions
- Arthropathy of Knee Joint
- Keywords
- Prothesis fixation, Bloodlessness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 4 Mar 2011 (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.
Introduction:
Approximately 7000 total knee replacements (TKAs) are done every year. More than 90% of these knee replacements are performed with the use of bone cement. Traditionally, a tourniquet has been, used to reduce the bleeding during surgery, enabling surgeons to perform delicate dissections in a bloodless operative field.
A tourniquet can be defined as a constricting or compressing device used to control temporarily venous and arterial circulation to an extremity. Pressure is applied circumferentially on the skin and underlying tissues of a limb. This pressure is transferred to the walls of vessels, causing them to become occluded.
It is well known that applying a tourniquet for more than 1 to 2 hours is associated with a number of disadvantages, for instance, severe pain and muscle effects during the first postoperative day, thereby slowing rehabilitation.
Other side effects related to tourniquet use, include pulmonary embolus caused by venous thrombosis and arterial thrombosis as a result of the dislodgement of an arterial plaque. Furthermore, tourniquet-induced hypertension with general anaesthesia, muscle injury, a wide spectrum of neurologic injuries, and tissue changes (Oedema compartment syndrome, post-tourniquet syndrome) have been reported. An important fact is that bleeding affects the quality of binding between bone and cement and thereby fixation of the knee prosthesis? Since the introduction of modern cementing techniques, no previous clinical studies have investigated the advantages or disadvantages of tourniquet use in knee replacement surgery.
Aims/hypothesis of the study:
- To investigate the advantages and disadvantages of tourniquet use, including whether not using a tourniquet reduces pain, facilitates mobilisation and recovery, and shortens length of stay.
- To study whether use of a tourniquet affects leg muscles during and after surgery, as measured by with use of microdialysis to quantify level of ischemia .
- To determine whether prosthesis fixation, measured by RSA, is affected by tourniquet use. Because third generation cements secure prosthesis fixation, the investigators do not expect to find any clinically significant migration (less than 2 mm) 2 years after surgery.
Perspectives:
The investigators hope that the results of our study will improve rehabilitation regimes so that patients will experience less pain after surgery and thus achieve more rapid mobilisation and return to their daily lives.
Detailed description
Design
Patients being able to participate in this study all have to fulfill the given inclusion criteria:
- Patients with symptomatic and radiographic verified knee symptoms, selected for primary unilateral total knee joint replacement (TKA)
- Age 50 and above (not older than 85)
- BMI < 35 and height >160 cm
- No severe cardiovascular conditions
- No previously knee surgery done in the same knee
- Oral and written acceptance
A group concerning 2 x 30 patients will be randomized into two groups. Either an intervention group, with absence of tourniquet or a control group with tourniquet. Which group they will belong to, is blinded to patient and surgeon until they reach operation room. The operation will be performed as usual, but with exception of two additional procedures. During operation small spheric tantalum pellets are placed around the prosthesis. Furthermore patients are prepared for microdialysis, which contain placement of 3 catheters: one in each thigh and one subcutaneously in the abdomen.
Microdialysis is a unique technique to monitor the chemistry of the extracellular space in living tissue. It is primarily used for In Vivo determinations of endogenous metabolites, thus serving as an indicator for ischemia.
RSA is precision radiology where the small pellets are visual on x-ray. Using computer a 3D image is created and the pellets serve as markers. These markers will be measured every 6 months showing whether a possible migration of the prosthesis is occurring and thereby indicating a loosening.
Out-patient treatment Patients will among other things be followed by clinical functional scores, registration of analgetica use, conventional X-ray and RSA In the long run the perspective is that surgery concerning knee replacements will be conducted without the use of tourniquet and thereby reducing the pain of the patients without compromising the end result of the operation, namely the fixation of the prosthesis.
Permissions approved by the Regional Committee on Biomedical Research Ethics, Region of Northern Jutland and Danish Data Protection Agency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Tourniquet | Active comparator | Procedure: Total Knee ArthroplastyTotal Knee Arthroplasty. Surgery performed during use of a tourniquet. |
| Without Tourniquet | Experimental | Procedure: Total Knee ArthroplastyTotal Knee Arthroplasty. Surgery performed without use of a tourniquet. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with symptomatic and radiographic verified knee symptoms, selected for primary unilateral total knee joint replacement (TKR)
- Age 50 and above (not older than 85)
- BMI < 35 and height >160 cm
- No severe cardiovascular conditions
- No previously knee surgery done in the same knee
Key exclusion criteria (6 listed)
- Severe obesity
- rheumatic diseases
- Absence of pulse in foot
- Diabetes
- Previous operation in concerning knee
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 |
|---|---|---|
| Total Knee ArthroplastySurgery for OA knee pains | Procedure or surgery | With Tourniquet, Without Tourniquet |
Primary outcome
Determine whether prosthesis fixation, measured by RSA, is affected by tourniquet use.
Time frame: 1.Feb 2011 -1 jan 2013
To determine whether prosthesis fixation, measured by RSA, is affected by tourniquet use. Because third generation cements secure prosthesis fixation, we do not expect to find any clinically significant migration (less than 2 mm) 2 years after surgery.
1 secondary outcome
To investigate the advantages and disadvantages of tourniquet use, including whether not using a tourniquet reduces pain, facilitates mobilisation and recovery, and shortens length of stay.
Time frame: 1.feb 2011 - 1.jan 2013
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 30 Jan 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Knee Arthroplasty in people with Arthropathy of Knee Joint, run by Northern Orthopaedic Division, 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 6 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 30 Jan 2015. 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?
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?
Determine whether prosthesis fixation, measured by RSA, is affected by tourniquet use. (time frame: 1.Feb 2011 -1 jan 2013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2015; AzTrials last refreshed its copy on 6 Nov 2026.