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The Impact of Smoking on Outcomes and Complications in Total Joint Arthroplasty: A Prospective Crossover Study

The Impact of Smoking on Outcomes and Complications in Total Joint Arthroplasty: A Prospective Crossover Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04592302
Enrollment
1200
Registered
2020-10-19
Start date
2016-12-01
Completion date
2021-07-31
Last updated
2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking, Total Joint Arthroplasty

Brief summary

The purpose of this study is to examine the impact of smoking cessation on total joint arthroplasty patients with respect to perioperative complications and outcomes. The investigators will examine patients who are asked to stop smoking in any manner they choose and also refrain from nicotine replacement therapy, and those who are allowed to continue smoking during the perioperative period for their total knee or total hip replacement.

Interventions

DIAGNOSTIC_TESTBlood Draw

2-4 weeks before surgery a blood draw will be taken to test for nicotine levels in the body

Sponsors

Rothman Institute Orthopaedics
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

1. Primary elective total joint arthroplasty patients undergoing surgery with a Rothman Institute arthroplasty surgeon. 2. Participant is a current smoker. 3. Diagnosis of osteoarthritis, inflammatory arthritis, and post-traumatic arthritis. Exclusions criteria: 1. Age \< 18 2. Revision surgery 3. Prior infection in hip or knee at the surgical site 4. BMI \>40 (It is currently the standard of care in our practice to require patients to have a BMI \< 40 due to an increased risk of infection. This will not represent a change in practice.) 5. Diabetics with Hgb A1C \>8 (It is currently the standard of care in our practice to require patients to have a Hgb A1C \<8 due to an increased risk of infection. This will not represent a change in practice.) 6. Patients using chewing tobacco, cigars, or other form of oral tobacco product 7. Patients using e-cigarettes or vaporizers

Design outcomes

Primary

MeasureTime frameDescription
Wound healing3 monthsThe primary objective of this study is to examine the impact of smoking cessation on total joint arthroplasty patients with respect to combined complications. For the purpose of the study combined complications will include: major in-hospital complications (MI, CVA, PE, pneumonia, return to the operating room, mortality), wound complications, readmission at 90 days, 90-day major complications (MI, CVA, PE, pneumonia, return to the operating room, mortality), and wound complications (prolonged hospitalization due to a wound issue, prolonged drainage \> 7 days, superficial or deep SSI

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026