Persona Ti-Nidium の市販後臨床フォローアップ (TKA)
Persona® Ti-Nidium® Personalized Total Knee System Persona Ti-Nidium Total Knee System と機器を使用した、安全性、性能、および臨床的利点のデータを提供するための市販後の臨床フォローアップ研究
The main objectives of this study are to evaluate overall clinical performance and safety of the Persona Ti-Nidium implant in total knee arthroplasty.
調査の概要
状態
詳細な説明
The study design is a prospective, multicenter data collection model of the 510(k) cleared Persona Ti-Nidium Total Knee System. The study will require each site to obtain institutional review board (IRB) approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.
All study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty. Investigators will collect clinical data for a required 10 years. Follow-up clinical visits include Early Post-op, 6 months, 1 year, 2, 3, 5, 7 and 10 years post-operatively.
The objective of this study is to evaluate clinical performance, benefits and safety of the Persona Ti-Nidium implant in total knee arthroplasty.
Specific assessments include:
- Confirming the long-term safety, performance and clinical benefits of the Persona Ti-Nidium total knee system and instrumentation in primary and revision TKA.
- Verifying that, under normal use, the performance and clinical benefits of this device and its instrumentation conform to those intended by the manufacturer by recording patient-reported clinical outcomes measures (PROMs) and radiographic outcomes (if available).
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Colorado
-
Parker、Colorado、アメリカ、80134
- Denver Hip & Knee, Inc.
-
-
Maryland
-
Hyattsville、Maryland、アメリカ、20782
- MedStar Health Research Institute
-
-
Mississippi
-
Jackson、Mississippi、アメリカ、39202
- Mississippi Sports Medicine and Orthopaedic Center
-
-
New Mexico
-
Albuquerque、New Mexico、アメリカ、87110
- New Mexico Orthopaedic Associates
-
-
North Carolina
-
Durham、North Carolina、アメリカ、27708
- Duke University
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、アメリカ、19107
- Rothman Orthopaedic Institute
-
-
South Dakota
-
Rapid City、South Dakota、アメリカ、57701
- Monument Health Rapid City Hospital, Inc.
-
-
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:
- Patient is of legal age and skeletally mature
- Patient is willing and able to provide written Informed Consent by signing and dating the IRB-approved Informed Consent document
- Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol
- Patient qualifies for total knee arthroplasty based upon physical exam and medical history, and meets the approved indications for use of the Persona Ti-Nidium Knee System and Vivacit-E polyethylene articulating surface
- Independent of study participation, patient is a candidate for the commercially available Persona Ti-Nidium Knee and Vivacit-E polyethylene articulating surface, implanted in accordance with product labeling
Study Device Inclusion Criteria:
The Persona Ti-Nidium Total Knee is intended for patients with severe pain and disability due to the following:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Collagen disorders, and/or avascular necrosis of the femoral condyle.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- Moderate valgus, varus, or flexion deformities.
Exclusion Criteria:
- Patient is unwilling to sign the Informed Consent
- Patient is currently participating in any other surgical intervention or pain management study
- Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent)
- Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions
- Patient has a condition which would, in the judgement of the Investigator, place the patient at undue risk or interfere with the conduct of the study
- Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation
Study Device Exclusion Criteria
- Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint
- Insufficient bone stock on femoral or tibial surfaces
- Skeletal immaturity
- Neuropathic arthropathy
- Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
- A stable, painless arthrodesis in a satisfactory functional position
- Severe instability secondary to the absence of collateral ligament integrity
- Rheumatoid arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
- The kinematic alignment surgical technique is contraindicated for patients with greater than 5° valgus deformity with medial collateral ligament (MCL) insufficiency
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：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Persona Ti-Nidium
Primary total knee arthroplasty subjects that receive the Zimmer Biomet Persona Ti-Nidium Total Knee System |
Primary Knee Total Arthroplasty |
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 |
|---|---|---|
|
Oxford Knee Score (OKS)
時間枠：10 years
|
A patient reported functional outcome score for knee arthroplasty. This score ranges from 0-48, with higher scores indicating a better outcome. |
10 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Knee Society Score (KSS) Expectations (pre and post op)
時間枠：10 years
|
This is a 3 question form regarding a patient's expectations of the total knee replacement. The pre-op form assesses the patient's expectations of the knee replacement, and the post-op form addresses how the replacement is meeting said expectations. The score ranges from 3-15, with higher scores indicating a better outcome. |
10 years
|
|
EuroQol Five Dimension Five Level (EQ-5D-5L) Outcomes Measure
時間枠：10 years
|
A questionnaire completed by the patient and assesses his/her general health status. This score ranges from -0.573 to 1, with higher recorded scores indicating better overall health. |
10 years
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Hillary Overholser、Zimmer Biomet Assoc Director
研究記録日
主要日程の研究
研究開始 (実際)
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
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。