Tourniquet vs. no Tourniquet During Total Knee Arthroplasty

Osteoarthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02907047
• Other study ID #: 16Austin01
• Status: Completed
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: October 1, 2017

Study information

• Verified date: June 2019
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to correlate functional outcomes and perioperative complications with tourniquet use during total knee arthroplasty.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 1, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. All unilateral primary knee arthroplasties performed by investigators participating in this study will be eligible for inclusion

2. Diagnosis of osteoarthritis

Exclusion Criteria:

1. Revision surgery

2. Bilateral knee surgery

3. Age <18 or >80

4. BMI >40

5. Baseline lower extremity strength less than 5/5

6. Vascular calcifications

7. History of chronic narcotic use, defined as more than 5mg of oxycodone q4 hours

8. Functionally limiting spine disease

9. Other functionally limiting lower extremity disorder (i.e. symptomatic ipsilateral hip disease)

10. Patients who cannot perform the baseline functional tests

11. Allergy/contraindication to protocol medications

12. Post-traumatic arthritis

13. Inflammatory arthritis

14. Pregnancy

15. Prisoners

16. Patients receiving care as part of a worker's compensable injury

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Other:
• tourniquet inflated

• tourniquet not inflated

Locations

Country	Name	City	State
United States	Rothman Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	timed up and go (TUG) score		4 weeks following surgery
Primary	Stair Climb test	time, in seconds, to climb one flight of nine stairs	in hospital (usually less than 2 days), 4 weeks post-op, 6 months post-op
Primary	Visual Analog Scale: Pain		in hospital (usually less than 2 days), 4 weeks post-op, 6 months post-op
Secondary	blood loss	calculated blood loss determine by hemoglobin dilution	intra-operative
Secondary	surgical field visualization	subjective rating provided by the surgeon	intra-operative
Secondary	range of motion	measured, in degrees, using a goniometer	in hospital (usually less than 2 days), 4 weeks post-op, 6 months post-op