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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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?
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: John Green, MD
- Número de teléfono: 402-717-0820
- Correo electrónico: JohnGreen1@creighton.edu
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Periprosthetic joint infection (PJI) within 12 months, defined using Musculoskeletal Infection Society criteria (Parvizi, et al).
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
• Periprosthetic joint infection at 24, 36, 48, 60 and 120 months, defined using Musculoskeletal Infection Society criteria (Parvizi, et al).
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 3-5 years
|
3. To compare reoperation and revision arthroplasty rates for infection. |
3-5 years
|
|
• Causative organisms of PJI
Periodo de tiempo: 3-5 years
|
4. To characterize microbiologic profiles of PJIs. |
3-5 years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- CommonSpirit IRB 2447281-1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Results will otherwise be disseminated through academic journals as well as poster or podium presentations at academic meetings.
Tipo de información de apoyo para compartir IPD
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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