MARS MRI リビジョン THA セラミック大腿骨頭とチタン製スリーブ付き
メタル アーティファクト低減シーケンス MRI 再置換術 セラミック製大腿骨頭とチタン製スリーブによる人工股関節全置換術
Revision total hip replacement using a ceramic head utilizes a titanium sleeve which introduced another articulation into the system that may lead to a local soft tissue reaction. The purpose of this study is to determine the frequency, size and types of MRI documented local tissue reactions in individuals doing well after a revision total hip replacement and ceramic bearing surface that utilizes a titanium sleeve.
調査の概要
状態
条件
詳細な説明
Metal-on-metal total hip arthroplasty (THA) were heralded as a solution for two of the most common problems in hip arthroplasty in the last decade, instability and osteolysis. Unfortunately, their failures have led to diminished enthusiasm for this bearing surface. Adverse local tissue reactions (ATLRs) have been well documented as a means of pain and failure in this population. A recent report revealed that the most commonly used bearing surface in total hip arthroplasty, metal-on-polyethylene, may have up to a 28% incidence of MRI abnormalities in asymptomatic hips. Revision THA using a ceramic head utilizes a titanium sleeve which introduced another articulation into the system that may lead to a local soft tissue reaction. The purpose of this study is to determine the frequency, size and types of MRI documented local tissue reactions in asymptomatic individuals after a revision THA and ceramic bearing surface that utilizes a titanium sleeve. To our knowledge, this has not been studied previously and may provide important baseline features of this diagnostic tool with this particular bearing surface. We hypothesize that there will be fluid collections in a small but clinically significant portion of asymptomatic patients.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Colorado
-
Denver、Colorado、アメリカ、80210
- Colorado Joint Replacement
-
-
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
サンプリング方法
調査対象母集団
Patients who received a revision total hip surgery utilizing a ceramic femoral head with a titanium sleeve
説明
Inclusion Criteria:
- Patients who received a revision total hip surgery utilizing a ceramic femoral head with a titanium sleeve
- Patient whose age ranges from 18-99
- Patients who are not experiencing groin pain, thigh pain, or pain with ROM of the hip
- Patients who are at least 2 years after a revision THA
- Acetabular implant (cup) was placed in the appropriate position
- Patients with a Harris Hip Score of >90
Exclusion Criteria:
- Patients who do not meet the above criteria
- Patients unable to have an MRI (i.e. pacemaker, metal implants or issues with claustrophobia requiring sedation)
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
- 観測モデル:CASE_ONLY
- 時間の展望:PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Revision Total Hip Arthroplasty
Patients who received a revision total hip surgery utilizing a ceramic femoral head with a titanium sleeve |
metal artifact reduction sequence (MARS) MRI to assess for fluid collections, ATLRs or other abnormalities Labs to look at titanium levels in blood Labs to look at cobalt levels in blood Labs to look at chromium levels in blood |
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 |
|---|---|---|
|
MARS MRI abnormalities
時間枠:2 Years Post Revision Total Hip Replacement
|
Local Tissue Reactions or Fluid collections on the MARS MRI Scan |
2 Years Post Revision Total Hip Replacement
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Titanium Lab Value
時間枠:2 Years Post Revision Total Hip Replacement
|
Titanium levels in blood |
2 Years Post Revision Total Hip Replacement
|
|
Chromium Lab Value
時間枠:2 Years Post Revision Total Hip Replacement
|
Chromium levels in blood |
2 Years Post Revision Total Hip Replacement
|
|
Cobalt Lab Value
時間枠:2 Years Post Revision Total Hip Replacement
|
Cobalt levels in blood |
2 Years Post Revision Total Hip Replacement
|
協力者と研究者
捜査官
- 主任研究者:Jason M Jennings, MD、Colorado Joint Replacement
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。