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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01162720
Registration number
NCT01162720
Ethics application status
Date submitted
6/07/2010
Date registered
15/07/2010
Date last updated
30/03/2011
Titles & IDs
Public title
Short- Versus Long-duration Tourniquet Use During Total Knee Replacement (TKR)
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Scientific title
Feasibility of Tourniquet Use During Cement Fixation Only for TKR Surgery
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Secondary ID [1]
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2008-15
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Secondary ID [2]
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FairfieldHJCD
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Arthroplasty, Replacement, Knee
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Long duration tourniquet
Treatment: Surgery - Short duration tourniquet
Experimental: 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.
Active Comparator: Long duration tourniquet - Patients randomised to this arm will have the tourniquet applied from commencement of surgery and removed just prior to skin closure.
Treatment: Surgery: Long duration tourniquet
Patients randomised to this arm will have the tourniquet applied at the commencement of surgery and removed prior to wound closure.
Treatment: Surgery: 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).
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Oxford Knee score
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Assessment method [1]
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Oxford knee score is a disease-specific patient perceived knee pain and function survey. It will be collected at baseline (within 2 months of surgery), and then at 10, 26 and 52 weeks post surgery.
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Timepoint [1]
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10 weeks post surgery
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Primary outcome [2]
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Donor blood transfusion rate
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Assessment method [2]
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The use of donor blood transfusion in the intra-operative and acute post-operative (hospitalisation) period will be recorded. Criteria for donor blood transfusion is according to the hospital's restrictive transfusion practices.
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Timepoint [2]
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Within the acute hospitalisation period (from Day 0 (surgery day), to day of discharge)
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Secondary outcome [1]
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Knee range of motion (ROM)
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Assessment method [1]
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Knee ROM will be assessed photographically according to a method developed by some of the investigators. Photographs taken of the patient's knee in end passive flexion and end passive extension will obtained from the patient in supine. ROM will be measured off the photographs.
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Timepoint [1]
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ROM will be assessed pre-operatively (within 2 months of surgery), on day 4 post surgery, and at 2, 10,26 and 52 weeks post surgery
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Secondary outcome [2]
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Quadriceps lag
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Assessment method [2]
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Quadriceps lag will be assessed with the patient in supine. As for ROM, lag will be measured off photographs. It will be calculated as the difference between full passive knee extension and active extension. Passive end extension will be assessed as previously described. Active extension will be obtained in the same position, but with a towel (or suitable object) under the knee. The patient will attempt to raise their heel off the bed. The knee extension range measured when doing this is called the active extension range.
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Timepoint [2]
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Lag will be assessed on Day 4 post surgery, and at 2, 10, 26 and 52 weeks post surgery.
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Secondary outcome [3]
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timed stair test
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Assessment method [3]
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Time (sec)to walk up 10 stairs. Time to walk down 10 stairs. Power will also be calculated from the time together with body weight and step height. The test is not strictly a power test (particularly at 2 weeks)as walking aids/rails can be used as required.
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Timepoint [3]
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Measured at 2, 10,26 and 52 weeks post-surgery
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Secondary outcome [4]
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Knee pain
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Assessment method [4]
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Knee pain measured using a 10cm visual analogue scale
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Timepoint [4]
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Measured on Day 4 post surgery
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Secondary outcome [5]
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Analgesic consumption
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Assessment method [5]
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The morphine equivalent will be calculated from both PCA and oral analgesic consumption.
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Timepoint [5]
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Measured over course of acute care (summation of day 0 to day of discharge)
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Eligibility
Key inclusion criteria
- primary, unilateral knee replacement;
- capacity to understand the protocol;
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- inability to read English;
- 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)
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Study design
Purpose of the study
Supportive Care
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2010
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Sample size
Target
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Accrual to date
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Final
65
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Fairfield Hospital - Sydney
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Recruitment postcode(s) [1]
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2176 - Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
Fairfield Hospital, Australia
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
To establish whether a short duration of tourniquet application (from cement fixation to
cement setting)is associated with better patient functional outcomes compared to a long
duration of tourniquet application (from surgical incision to cement setting).
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01162720
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Trial related presentations / publications
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. Erratum In: J Bone Joint Surg Br 1997 Jul;79(4):693. Barwell NJ [corrected to Barwell J].
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Public notes
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Contacts
Principal investigator
Name
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Jay Dave, MBBS
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Address
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Surgeon at Fairfield Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01162720
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