Short- Versus Long-duration Tourniquet Use During Total Knee Replacement (TKR)
NCT ID: NCT01162720
Last Updated: 2011-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
65 participants
INTERVENTIONAL
2008-11-30
2010-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
It is hypothesised that tourniquet application during cement fixation only (approximately of 20-30 min duration) will be associated with less pain and impairment than a longer tourniquet application (\> 45 minutes).
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Tourniquets are commonly used during total knee replacement (TKR) surgery to provide a bloodless field to improve visualisation \[1\]. The optimum timing of tourniquet release (ie prior to or after wound closure) has been the subject of many randomised controlled trials with a recent meta-analysis \[1\] concluding that whilst early release may increase blood loss, it may protect patients from regional complications requiring re-operation such as wound dehiscence, haematomas requiring drainage, knee stiffness and infection. Thus, there is good evidence to suggest that tourniquet use of short duration may be optimal as far as complications are concerned. Few studies have looked at the effect of tourniquet duration on functional recovery, but one \[2\] observed that quadriceps lag recovered more quickly if short duration tourniquet was used. There has been no research to date on using a tourniquet just during cement fixation of the prosthesis when good visualisation is key to preventing blood-cement mixing. Such an approach is important to investigate as it could further reduce the risks of tourniquet use. However, tourniquet use of such short duration may increase blood loss and increase the risk for donor blood transfusion.
Aim: To establish whether a short duration of tourniquet application (from cement fixation to cement setting)is associated with better outcomes compared to a long duration of tourniquet application (from surgical incision to cement setting).Research Design: A randomised controlled trial will be used to assess the research hypothesis. The research hypothesis is that tourniquet use during cement fixation only will be associated with better physical and functional recovery. However, it may be associated with greater need for donor blood transfusion. Methods: Consenting patients will be randomly allocated to have tourniquet use of either short or long duration in the operating theatre after the patient has been anaesthetised.The tourniquet will be applied at the time of the first skin incision (standard practice for the surgeons involved) for those allocated to the Long-Duration Group, and applied just during cement fixation of the prosthesis for the Short-Duration Group. In both groups, the tourniquet will be removed when the cement has set.
Assessments will be conducted at baseline (up to 6-weeks before surgery during a pre-admission visit), at discharge, then at 2,10, 26 and 52 weeks post surgery. The outcomes of interest include patient-centred measures (Oxford knee score -primary outcome)and other physical measures such as stair climbing test quadriceps lag, and knee range of motion. As the risk of donor blood transfusion may increase with short tourniquet duration, the use of donor blood is also a primary outcome. Reinfusion drains will be used routinely on all patients in order to reduce the need for donor blood. All enrolled patients will undergo a screening leg doppler and another at 2 weeks post surgery for detection of DVTs. Length of stay, and discharge destination (home versus rehabilitation),will also be recorded. Complication type and frequency (including evidence of prosthesis loosening in the first year) will be monitored. The study will be powered to detect a significant difference in Oxford scores. Thus, a sample size of 200 patients will provide sufficient power (80%) at 0.05 significance level to detect a 0.5SD difference in Oxford scores between the 2 treatment arms. This provides for a 20% loss to follow-up and also provides sufficient numbers to detect a large absolute difference (\> 20%) in transfusion rate between the groups.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Short duration tourniquet
Patients allocated to this group will have the pneumatic tourniquet applied to the index limb for approximately 20-30 minutes during cement fixation of the prosthesis.
Short duration tourniquet
Patients assigned to this arm will have the tourniquet applied during cement fixation of the prosthesis only (ie removed just prior to wound closure).
Long duration tourniquet
Patients randomised to this arm will have the tourniquet applied from commencement of surgery and removed just prior to skin closure.
Long duration tourniquet
Patients randomised to this arm will have the tourniquet applied at the commencement of surgery and removed prior to wound closure.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Long duration tourniquet
Patients randomised to this arm will have the tourniquet applied at the commencement of surgery and removed prior to wound closure.
Short duration tourniquet
Patients assigned to this arm will have the tourniquet applied during cement fixation of the prosthesis only (ie removed just prior to wound closure).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* capacity to understand the protocol;
Exclusion Criteria
* current warfarin therapy (or similar);
* significant PVD, peripheral arterial disease or diabetes rendering tourniquet use undesirable;
* evidence of chronic or recent DVT in index limb;
* thigh circumference \> 100 cm (approximately);
* Jehovah's Witness (ie refusal to receive donor blood)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fairfield Hospital, Australia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Fairfield Hospital
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jay Dave, MBBS
Role: PRINCIPAL_INVESTIGATOR
Surgeon at Fairfield Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fairfield Hospital
Sydney, New South Wales, Australia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Rama KR, Apsingi S, Poovali S, Jetti A. Timing of tourniquet release in knee arthroplasty. Meta-analysis of randomized, controlled trials. J Bone Joint Surg Am. 2007 Apr;89(4):699-705. doi: 10.2106/JBJS.F.00497.
Barwell J, Anderson G, Hassan A, Rawlings I. The effects of early tourniquet release during total knee arthroplasty: a prospective randomized double-blind study. J Bone Joint Surg Br. 1997 Mar;79(2):265-8. doi: 10.1302/0301-620x.79b2.7191.
Mittal R, Ko V, Adie S, Naylor J, Dave J, Dave C, Harris IA, Hackett D, Ngo D, Dietsch S. Tourniquet application only during cement fixation in total knee arthroplasty: a double-blind, randomized controlled trial. ANZ J Surg. 2012 Jun;82(6):428-33. doi: 10.1111/j.1445-2197.2012.06083.x. Epub 2012 May 10.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2008-15
Identifier Type: OTHER
Identifier Source: secondary_id
FairfieldHJCD
Identifier Type: -
Identifier Source: org_study_id