Tourniquet vs. no Tourniquet During Total Knee Arthroplasty

• Sponsor: Rothman Institute Orthopaedics (Other)
• Overall Status: Completed
• CT.gov ID: NCT02907047
• Collaborator: (none)
• Location: 1
• Arms: 2
• Actual Duration (Months): 16

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Other: tourniquet inflated; Other: tourniquet not inflated	N/A

Study Design

• Study Type: Interventional
• Intervention Model: Parallel Assignment
• Actual Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Apr 1, 2017
• Actual Study Completion Date: Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Tourniquet These subjects will have their tourniquet inflated during key portions of the total knee arthroplasty procedure	Other: tourniquet inflated
Other: No tourniquet These subjects will not have their tourniquet inflated during key portions of the total knee arthroplasty procedure	Other: tourniquet not inflated

Outcome Measures

Primary Outcome Measures

1. timed up and go (TUG) score [4 weeks following surgery]

2. Stair Climb test [in hospital (usually less than 2 days), 4 weeks post-op, 6 months post-op]

   time, in seconds, to climb one flight of nine stairs

3. Visual Analog Scale: Pain [in hospital (usually less than 2 days), 4 weeks post-op, 6 months post-op]

Secondary Outcome Measures

1. blood loss [intra-operative]

   calculated blood loss determine by hemoglobin dilution

2. surgical field visualization [intra-operative]

   subjective rating provided by the surgeon

3. range of motion [in hospital (usually less than 2 days), 4 weeks post-op, 6 months post-op]

   measured, in degrees, using a goniometer

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rothman Institute	Philadelphia	Pennsylvania	United States	19148

Sponsors and Collaborators

• Rothman Institute Orthopaedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rothman Institute Orthopaedics
• ClinicalTrials.gov Identifier: NCT02907047
• Other Study ID Numbers: 16Austin01
• First Posted: Sep 20, 2016
• Last Update Posted: Jul 1, 2019
• Last Verified: Jun 1, 2019

• Additional relevant MeSH terms: Osteoarthritis

Study Results

No Results Posted as of Jul 1, 2019