Tourniquet and Quadricepsforce

NCT01808859 | Completed

• 1 other identifier: Biodex2013
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose for this study is to investigate the quadriceps (thigh) function preoperatively and 48 hours postoperatively during knee arthroplasty (total replacement of the knee joint) in a randomised study with or without the use of a Tourniquet (cuff around the thigh during surgery) (100 mm Hg \> systolic blood pressure).

Conditions

Osteoarthritis; Total Knee Arthroplasty

Keywords

Total Knee Arthroplasty; Thigh Tourniquet

Outcome Measures

Primary Outcomes (1)

• isometric quadriceps-force measured

  isometric quadriceps-force measured in an isokinetic dynameter (Biodex III). The patient is sitting in the dynameter-chair with 60° knee-flexion. After a pretest training, instruction and two suboptimal trials, the patient will do 5 maximal isometric knee-extensions. The highest value measured will be expressed as the quadriceps-force in Nm/Kg bodyweight \[1\]. The knee circumference will be measured 1 cm proximal to the base of the patella with the patient relaxed in the supine position and the knee extended \[13\] The Quadriceps circumference will be measured 10 cm proximal to the base of the patella with the patient in supine position and the knee extended.

  pre operatively and 48 hrs post op

Secondary Outcomes (1)

• Pain

  pre opertively and 48 hrs post op

Other Outcomes (2)

• The bloodloss

  within 30 min after end of surgery

• length of hospital stay

  the time att which surgery ends untill the time of discharge

Study Arms (2)

Tourniquet

EXPERIMENTAL

The Torniquet will be inflated to 100 mmHg over systolic pressure just before skin incision. The tourniquet will be deflated when the last stich/agraf is fixed

Device: Tourniquet

No tourniquet

NO INTERVENTION

The patients operated on in the non-tourniquet group will have the same surgery and surgical technique but without tourniquet hyperbaric bupivacaine 12.5-15 mg Celecoxib 400 mg and paracetamol 1 g will be given preoperatively. Postoperatively celecoxib 200 mg x 2 and paracetamol 1 g/6 h is given is given for 2 weeks.

Interventions

Tourniquet DEVICE

hyperbaric bupivacaine 12.5-15 mg Celecoxib 400 mg and paracetamol 1 g will be given preoperatively. Postoperatively celecoxib 200 mg x 2 and paracetamol 1 g/6 h is given is given for 2 weeks.

Tourniquet

Eligibility Criteria

• Age: 41 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients \> 40 \< 80 years planed for a total knee arthroplasty The patient will be given a written informed consent to participate in this clinical investigation.
• The patient understand the clinical investigation and will cooperate with the investigational team

You may not qualify if:

• Preoperatively \<90 flexion, \> 10 extensionsdeficit. Rheumatoid arthritis, other forms of inflammatory disease or autoimmune disorders Immunosuppresed patient Systemic corticosteroid used in previous 6 month Previous major knee surgery as osteotomy, knee related fractures, BMI\<35 Diabethic neuropathy Preopratively opiod or garbabentine treatment Psychiatric disorders Planed for simultaneous bilateral knee arthroplasty

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Dept Orthopedic surgery, Hässleholm Hospital

Hässleholm, Skåne County, 281 25, Sweden

Location

Related Publications (6)

• Holm B, Kristensen MT, Bencke J, Husted H, Kehlet H, Bandholm T. Loss of knee-extension strength is related to knee swelling after total knee arthroplasty. Arch Phys Med Rehabil. 2010 Nov;91(11):1770-6. doi: 10.1016/j.apmr.2010.07.229.

  PMID: 21044725 BACKGROUND

• Meier W, Mizner RL, Marcus RL, Dibble LE, Peters C, Lastayo PC. Total knee arthroplasty: muscle impairments, functional limitations, and recommended rehabilitation approaches. J Orthop Sports Phys Ther. 2008 May;38(5):246-56. doi: 10.2519/jospt.2008.2715. Epub 2007 Dec 14.

  PMID: 18448878 BACKGROUND

• Mizner RL, Petterson SC, Stevens JE, Vandenborne K, Snyder-Mackler L. Early quadriceps strength loss after total knee arthroplasty. The contributions of muscle atrophy and failure of voluntary muscle activation. J Bone Joint Surg Am. 2005 May;87(5):1047-53. doi: 10.2106/JBJS.D.01992.

  PMID: 15866968 BACKGROUND

• Smith TO, Hing CB. Is a tourniquet beneficial in total knee replacement surgery? A meta-analysis and systematic review. Knee. 2010 Mar;17(2):141-7. doi: 10.1016/j.knee.2009.06.007. Epub 2009 Jul 19.

  PMID: 19616954 BACKGROUND

• Ledin H, Aspenberg P, Good L. Tourniquet use in total knee replacement does not improve fixation, but appears to reduce final range of motion. Acta Orthop. 2012 Oct;83(5):499-503. doi: 10.3109/17453674.2012.727078. Epub 2012 Sep 14.

  PMID: 22974220 BACKGROUND

• Harsten A, Bandholm T, Kehlet H, Toksvig-Larsen S. Tourniquet versus no tourniquet on knee-extension strength early after fast-track total knee arthroplasty; a randomized controlled trial. Knee. 2015 Mar;22(2):126-30. doi: 10.1016/j.knee.2014.12.010. Epub 2014 Dec 31.

  PMID: 25648580 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

Tourniquets

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: February 28, 2013
• First Posted: March 11, 2013
• Study Start: February 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: July 1, 2014
• Last Updated: November 6, 2014

Record last verified: 2014-11

Locations

SE (1)