Is Routine Dental Clearance or Antibiotic Prophylaxis Before Dental Procedures Necessary in Total Joint Arthroplasty? A Randomized Controlled Noninferiority Trial
This study is a prospective, randomized, controlled, noninferiority trial with parallel assignment that will afford simultaneous assessment of the omission of dental clearance and the omission of post-operative antibiotics for dental procedures.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
A noninferiority design is chosen because elimination of a preoperative requirement may offer substantial benefits in cost, access, and timeliness of care; provided infection risk is not meaningfully increased.
Study Questions
- Is omission of routine preoperative dental clearance non-inferior to mandatory dental clearance with respect to prosthetic joint infection risk following elective primary hip or knee arthroplasty?
- Is omission of routine postoperative antibiotic prophylaxis non-inferior to prescription of routine antibiotic prophylaxis with respect to prosthetic joint infection risk following elective primary hip or knee arthroplasty?
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: John Green, MD
- Telefonnummer: 402-717-0820
- E-Mail: JohnGreen1@creighton.edu
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria
- Age ≥19 years (19 is age of majority in Nebraska)
- Scheduled for elective primary THA or TKA (i.e. no revision or conversion procedures)
- Ability to provide informed consent
Exclusion Criteria
- Revision arthroplasty
- Arthroplasty for fracture or performed urgently (i.e. incomplete work up)
- Active or previous infection of the operative joint
- Active systemic infection
- On chronic antibiotic therapy
All patients who meet the above criteria will be offered inclusion in the study either at their pre-operative clinic visit or over the phone.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Kein Eingriff: 1. Obtains dental clearance and undergoes routine antibiotic prophylaxis
|
|
|
Experimental: 2. Omits dental clearance and undergoes routine antibiotic prophylaxis
|
Dental Clearance Group Participants will undergo standardized preoperative dental evaluation. Any dental treatment recommended by the treating dental provider must be completed prior to surgery, with written clearance documented before proceeding. No Dental Clearance Group Participants will proceed directly to arthroplasty without mandatory dental evaluation. Acute dental symptoms arising preoperatively will be managed according to standard clinical practice. Routine Antibiotic Prophylaxis Group Participants will receive antibiotic prophylaxis before every dental procedure, including routine cleanings:
No Antibiotic Prophylaxis Group Participants will receive no routine antibiotic prophylaxis prior to any dental procedure, including cleanings. All other dental care will proceed per standard practice. |
|
Experimental: 3. Obtains dental clearance and omits routine antibiotic prophylaxis
|
Dental Clearance Group Participants will undergo standardized preoperative dental evaluation. Any dental treatment recommended by the treating dental provider must be completed prior to surgery, with written clearance documented before proceeding. No Dental Clearance Group Participants will proceed directly to arthroplasty without mandatory dental evaluation. Acute dental symptoms arising preoperatively will be managed according to standard clinical practice. Routine Antibiotic Prophylaxis Group Participants will receive antibiotic prophylaxis before every dental procedure, including routine cleanings:
No Antibiotic Prophylaxis Group Participants will receive no routine antibiotic prophylaxis prior to any dental procedure, including cleanings. All other dental care will proceed per standard practice. |
|
Experimental: 4. Omits dental clearance and routine antibiotic prophylaxis
|
Dental Clearance Group Participants will undergo standardized preoperative dental evaluation. Any dental treatment recommended by the treating dental provider must be completed prior to surgery, with written clearance documented before proceeding. No Dental Clearance Group Participants will proceed directly to arthroplasty without mandatory dental evaluation. Acute dental symptoms arising preoperatively will be managed according to standard clinical practice. Routine Antibiotic Prophylaxis Group Participants will receive antibiotic prophylaxis before every dental procedure, including routine cleanings:
No Antibiotic Prophylaxis Group Participants will receive no routine antibiotic prophylaxis prior to any dental procedure, including cleanings. All other dental care will proceed per standard practice. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Periprosthetic joint infection (PJI) within 12 months, defined using Musculoskeletal Infection Society criteria (Parvizi, et al).
Zeitfenster: 12 Months
|
1. To determine whether omission of routine preoperative dental clearance is non-inferior to mandatory dental clearance in preventing periprosthetic joint infection within 12 months following primary TJA. |
12 Months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
• Periprosthetic joint infection at 24, 36, 48, 60 and 120 months, defined using Musculoskeletal Infection Society criteria (Parvizi, et al).
Zeitfenster: 120 months
|
5. To determine whether the omission of dental clearance or omission of routine dental clearance is non-inferior to routine use of these perioperatively at longer term follow up (2, 5 and 10 years). |
120 months
|
|
• Time from scheduling to surgery (i.e. delay caused by dental clearance)
Zeitfenster: 3-5 years
|
1. To compare time from surgical scheduling to operative date. |
3-5 years
|
|
• Rate of patients requiring dental procedure before getting dental clearance
Zeitfenster: 3-5 years
|
2. To determine the rate of dental intervention in patients requiring clearance. |
3-5 years
|
|
• Number of reoperations and which procedure is performed for PJI.
Zeitfenster: 3-5 years
|
3. To compare reoperation and revision arthroplasty rates for infection. |
3-5 years
|
|
• Causative organisms of PJI
Zeitfenster: 3-5 years
|
4. To characterize microbiologic profiles of PJIs. |
3-5 years
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- CommonSpirit IRB 2447281-1
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
Results will otherwise be disseminated through academic journals as well as poster or podium presentations at academic meetings.
Art der unterstützenden IPD-Freigabeinformationen
- SAFT
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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