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.
調査の概要
状態
詳細な説明
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?
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：John Green, MD
- 電話番号：402-717-0820
- メール：JohnGreen1@creighton.edu
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：1. Obtains dental clearance and undergoes routine antibiotic prophylaxis
|
|
|
実験的：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. |
|
実験的：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. |
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Periprosthetic joint infection (PJI) within 12 months, defined using Musculoskeletal Infection Society criteria (Parvizi, et al).
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
• Periprosthetic joint infection at 24, 36, 48, 60 and 120 months, defined using Musculoskeletal Infection Society criteria (Parvizi, et al).
時間枠：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)
時間枠：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
時間枠：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.
時間枠：3-5 years
|
3. To compare reoperation and revision arthroplasty rates for infection. |
3-5 years
|
|
• Causative organisms of PJI
時間枠：3-5 years
|
4. To characterize microbiologic profiles of PJIs. |
3-5 years
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- CommonSpirit IRB 2447281-1
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Results will otherwise be disseminated through academic journals as well as poster or podium presentations at academic meetings.
IPD 共有サポート情報タイプ
- SAP
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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