Short- Versus Long-duration Tourniquet Use During Total Knee Replacement (TKR)

NCT01162720 | Terminated DMC

• 2 other identifiers: FairfieldHJCD2008-15
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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).

Conditions

Arthroplasty, Replacement, Knee

Keywords

Primary knee replacement; Unilateral knee replacement

Outcome Measures

Primary Outcomes (2)

• Oxford Knee score

  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.

  10 weeks post surgery

• Donor blood transfusion rate

  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.

  Within the acute hospitalisation period (from Day 0 (surgery day), to day of discharge)

Secondary Outcomes (5)

• Knee range of motion (ROM)

  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

• Quadriceps lag

  Lag will be assessed on Day 4 post surgery, and at 2, 10, 26 and 52 weeks post surgery.

• timed stair test

  Measured at 2, 10,26 and 52 weeks post-surgery

• Knee pain

  Measured on Day 4 post surgery

• Analgesic consumption

  Measured over course of acute care (summation of day 0 to day of discharge)

Study Arms (2)

Short duration tourniquet

EXPERIMENTAL

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.

Procedure: Short duration tourniquet

Long duration tourniquet

ACTIVE COMPARATOR

Patients randomised to this arm will have the tourniquet applied from commencement of surgery and removed just prior to skin closure.

Procedure: Long duration tourniquet

Interventions

Long duration tourniquet PROCEDURE

Patients randomised to this arm will have the tourniquet applied at the commencement of surgery and removed prior to wound closure.

Long duration tourniquet

Short duration tourniquet PROCEDURE

Patients assigned to this arm will have the tourniquet applied during cement fixation of the prosthesis only (ie removed just prior to wound closure).

Short duration tourniquet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary, unilateral knee replacement;
• capacity to understand the protocol;

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fairfield Hospital, Australia: lead

Study Sites (1)

Fairfield Hospital

Sydney, New South Wales, 2176, Australia

Location

Related Publications (3)

• 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.

  PMID: 17403789 BACKGROUND

• 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.

  PMID: 9119854 BACKGROUND

• 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.

  PMID: 22571508 DERIVED

Study Officials

• Jay Dave, MBBS

  Surgeon at Fairfield Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 6, 2010
• First Posted: July 15, 2010
• Study Start: November 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 30, 2011

Record last verified: 2011-03

Locations

AU (1)