OsteoarthritisNCT02203045
Outcomes Following Tourniquet and Non-Tourniquet Assisted Total Knee Arthroplasty
A study testing Total Knee Arthroplasty in people with Osteoarthritis, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
The overall goal of this study is to determine the effects of intraoperative tourniquet use during total knee arthroplasty (TKA), compared to TKA without the use of a tourniquet (NOTQT), for strength and functional recovery following simultaneous bilateral TKA. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Total Knee Arthroplasty
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2012to Aug 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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- undergoing primary, simultaneous bilateral knee arthroplasty for osteoarthritis
Who cannot join
- no neurological, vascular or cardiac problems that limit function or any unstable orthopaedic conditions that limit functional performance
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Univeristy of Colorado
Aurora, Colorado, 80045
Colorado Joint Replacement
Denver, Colorado, 80210
About this study
The overall goal of this study is to determine the effects of intraoperative tourniquet use during total knee arthroplasty (TKA), compared to TKA without the use of a tourniquet (NOTQT), for strength and functional recovery following simultaneous bilateral TKA. During the procedure, each patient will receive tourniquet-assisted TKA (TQT) on one lower extremity while the contralateral lower extremity undergoes TKA without the use of a tourniquet (NOTQT), except for briefly during component cementation. Tourniquets are commonly used in TKA to improve visualization of the surgical field and limit blood loss. However, studies suggest that tourniquet use may be associated with higher rates of medical complications and poor functional outcomes, including increased swelling, decreased muscle strength and altered neuromuscular activity. We will measure strength, voluntary muscle activation, and other functional outcomes for each lower extremity at 4 time points (preop; inpatient (24-72 hrs after surgery); 3 weeks; and 3 months following TKA). We hypothesize that lower extremities in the NOTQT group will demonstrate improved strength and performance when compared to lower extremities in the TQT group.
- Conditions
- Osteoarthritis
- Being tested
- Total Knee Arthroplasty
- Keywords
- 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.
Total Knee ArthroplastyOther
| Study group | Role | What they receive |
|---|---|---|
| Tourniquet | Active comparator | All lower extremities will be exsanguinated by elevation for 2 minutes. For lower extremities in the tourniquet group (TQT), a pneumatic tourniquet will be inflated according to standard practice (>200 mmHg). For the NOTQT group, the tourniquet will only be inflated during component cementation. In both groups, tourniquet will be deflated after bone cement has set. In both groups, electrocautery will be used as needed throughout the procedure. Receives: Other: Total Knee Arthroplasty |
| Non- tourniquet | Experimental | All lower extremities will be exsanguinated by elevation for 2 minutes. For lower extremities in the tourniquet group (TQT), a pneumatic tourniquet will be inflated according to standard practice (>200 mmHg). For the NOTQT group, the tourniquet will only be inflated during component cementation. In both groups, tourniquet will be deflated after bone cement has set. In both groups, electrocautery will be used as needed throughout the procedure. Receives: Other: Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Quadriceps Muscle Force
NOTQT will result in greater quadriceps muscle strength (primary outcome) after TKA, compared to TQT group. Benefits will be apparent at 48-72 hrs and 3 weeks (primary endpoint), and persist though 3 months following TKA
Measured: Pre-operative, 3 weeks and 3 months post-operative
Secondary outcomes (4)
Change from Baseline in Balance testing
Patients will be asked to perform a test of unilateral balance ability. Patients will place both hands on their hips before assuming a single limb stance. Patients will attempt to hold this position for a maximum time of 60 seconds, although timing will stop if patients ever place both feet on the ground, if the non-stance leg braces against the stance leg to control balance, or if hands are removed from the hips to regain balance.
Measured: Pre-operatively, 3 weeks and 3 months post-operative
Change from Baseline in Isometric Hamstring Strength
Measured: Pre-operatively, 3 weeks and 3 months post-operative
Change from Baseline from Voluntary Quadriceps Activation
Measured: Pre-operative, 3 weeks and 3 months post-operative
Change from Baseline in Range of Motion
Knee flexion and extension range of motion (ROM) will be quantified using a standard long-arm goniometer with the patient lying in supine. Knee flexion ROM will be defined as the angle of maximal active bending of the knee. Knee extension ROM will be the angle of maximal straightening while the patient's heel is propped on a 10cm wooden block. If hyperextension is achieved, then the degrees of extension beyond zero will be recorded as a negative value.
Measured: Pre-operatively, 3 weeks and 3 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study startOct 2012
- Primary completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado Joint Replacement, CommonSpirit Health
- Responsible party
- Sponsor
- Investigators
- Douglas Dennis, MD, Principal investigator, Colorado Joint ReplacementJennifer Stevens-Lapsley, MPT and PhD, Study director, University of Colorado, DenverRay Kim, MD, Principal investigator, Colorado Joint Replacement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02203045
- Sponsor's protocol ID
- 12-0648
- Status last verified
- Oct 2014
- First submitted
- 24 Jul 2014
- Last updated
- 15 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes Following Tourniquet and Non-Tourniquet Assisted Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02203045
- Acronym / sponsor ID
- 12-0648
- Conditions
- Osteoarthritis
- Keywords
- Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Colorado Joint Replacement, CommonSpirit Health
- Study start
- Oct 2012
- Primary completion
- Aug 2014 (actual)
- First posted
- 29 Jul 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.
The overall goal of this study is to determine the effects of intraoperative tourniquet use during total knee arthroplasty (TKA), compared to TKA without the use of a tourniquet (NOTQT), for strength and functional recovery following simultaneous bilateral TKA. During the procedure, each patient will receive tourniquet-assisted TKA (TQT) on one lower extremity while the contralateral lower extremity undergoes TKA without the use of a tourniquet (NOTQT), except for briefly during component cementation. Tourniquets are commonly used in TKA to improve visualization of the surgical field and limit blood loss. However, studies suggest that tourniquet use may be associated with higher rates of medical complications and poor functional outcomes, including increased swelling, decreased muscle strength and altered neuromuscular activity. We will measure strength, voluntary muscle activation, and other functional outcomes for each lower extremity at 4 time points (preop; inpatient (24-72 hrs after surgery); 3 weeks; and 3 months following TKA). We hypothesize that lower extremities in the NOTQT group will demonstrate improved strength and performance when compared to lower extremities in the TQT group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tourniquet | Active comparator | Other: Total Knee ArthroplastyAll lower extremities will be exsanguinated by elevation for 2 minutes. For lower extremities in the tourniquet group (TQT), a pneumatic tourniquet will be inflated according to standard practice (>200 mmHg). For the NOTQT group, the tourniquet will only be inflated during component cementation. In both groups, tourniquet will be deflated after bone cement has set. In both groups, electrocautery will be used as needed throughout the procedure. |
| Non- tourniquet | Experimental | Other: Total Knee ArthroplastyAll lower extremities will be exsanguinated by elevation for 2 minutes. For lower extremities in the tourniquet group (TQT), a pneumatic tourniquet will be inflated according to standard practice (>200 mmHg). For the NOTQT group, the tourniquet will only be inflated during component cementation. In both groups, tourniquet will be deflated after bone cement has set. In both groups, electrocautery will be used as needed throughout the procedure. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- undergoing primary, simultaneous bilateral knee arthroplasty for osteoarthritis
Key exclusion criteria (1 listed)
- no neurological, vascular or cardiac problems that limit function or any unstable orthopaedic conditions that limit functional performance
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 Arthroplasty | Other | Non- tourniquet, Tourniquet |
Primary outcome
Change from baseline in Quadriceps Muscle Force
Time frame: Pre-operative, 3 weeks and 3 months post-operative
NOTQT will result in greater quadriceps muscle strength (primary outcome) after TKA, compared to TQT group. Benefits will be apparent at 48-72 hrs and 3 weeks (primary endpoint), and persist though 3 months following TKA
4 secondary outcomes
Change from Baseline in Balance testing
Time frame: Pre-operatively, 3 weeks and 3 months post-operative
Change from Baseline in Isometric Hamstring Strength
Time frame: Pre-operatively, 3 weeks and 3 months post-operative
Change from Baseline from Voluntary Quadriceps Activation
Time frame: Pre-operative, 3 weeks and 3 months post-operative
Change from Baseline in Range of Motion
Time frame: Pre-operatively, 3 weeks and 3 months post-operatively
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 15 May 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.
Douglas Dennis, MD principal investigator
Colorado Joint Replacement
Jennifer Stevens-Lapsley, MPT and PhD study director
University of Colorado, Denver
Ray Kim, MD principal investigator
Colorado Joint Replacement
2 sites 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 Osteoarthritis, run by University of Colorado, Denver at 2 sites in United States.
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 1 inclusion and 1 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 15 May 2015. 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 United States. 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?
Change from baseline in Quadriceps Muscle Force (time frame: Pre-operative, 3 weeks and 3 months post-operative). 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 15 May 2015.