Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
Scientific title
Feasibility of Tourniquet Use During Cement Fixation Only for TKR Surgery
Secondary ID [1] 0 0
2008-15
Secondary ID [2] 0 0
FairfieldHJCD
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthroplasty, Replacement, Knee 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Oxford Knee score
Timepoint [1] 0 0
10 weeks post surgery
Primary outcome [2] 0 0
Donor blood transfusion rate
Timepoint [2] 0 0
Within the acute hospitalisation period (from Day 0 (surgery day), to day of discharge)
Secondary outcome [1] 0 0
Knee range of motion (ROM)
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Quadriceps lag
Timepoint [2] 0 0
Lag will be assessed on Day 4 post surgery, and at 2, 10, 26 and 52 weeks post surgery.
Secondary outcome [3] 0 0
timed stair test
Timepoint [3] 0 0
Measured at 2, 10,26 and 52 weeks post-surgery
Secondary outcome [4] 0 0
Knee pain
Timepoint [4] 0 0
Measured on Day 4 post surgery
Secondary outcome [5] 0 0
Analgesic consumption
Timepoint [5] 0 0
Measured over course of acute care (summation of day 0 to day of discharge)

Eligibility
Key inclusion criteria
* primary, unilateral knee replacement;
* capacity to understand the protocol;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2010
Sample size
Target
Accrual to date
Final
65
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Fairfield Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2176 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Fairfield Hospital, Australia
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/study/NCT01162720
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].
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.
Public notes

Contacts
Principal investigator
Name 0 0
Jay Dave, MBBS
Address 0 0
Surgeon at Fairfield Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01162720