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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
NA
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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01162720