肩と股関節における MICROAPTOR™ 縫合糸アンカーの安全性と性能
肩および股関節鏡視下不安定性修復におけるMICRORAPTOR REGENESORB、Knotless REGENESORBおよびKnotless PEEK縫合糸アンカー（およびMINITAPE縫合糸）の安全性と性能を評価するための前向き多施設市販後臨床フォローアップ研究
調査の概要
状態
詳細な説明
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Colorado
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Aurora、Colorado、アメリカ、80045
- University of Colorado
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Colorado Springs、Colorado、アメリカ、80920
- Colorado Springs Orthopaedic Group
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Florida
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Oakland Park、Florida、アメリカ、33334
- Holy Cross Orthopedic Institute
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Georgia
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Brookhaven、Georgia、アメリカ、30329
- Emory University - Brookhaven
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Maryland
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Annapolis、Maryland、アメリカ、21401
- Luminis Health Research Institute
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Ohio
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Columbus、Ohio、アメリカ、43202
- Ohio State University Wexner Medical Center
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Oklahoma
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Oklahoma City、Oklahoma、アメリカ、73114
- Oklahoma Sports and Science Orthopedics / The Physician's Group
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South Carolina
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Columbia、South Carolina、アメリカ、29203
- Palmetto/Prisma Health - University of South Carolina Orthopaedics
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Greenville、South Carolina、アメリカ、29615
- Steadman Hawkins Clinic of the Carolinas
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Virginia
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Virginia Beach、Virginia、アメリカ、23452
- Atlantic Orthopaedic Specialists
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Woodbridge、Virginia、アメリカ、22191
- Center for Advanced Orthopaedics / Nova Orthopedic & Spine Care
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Wisconsin
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Ashland、Wisconsin、アメリカ、54806
- Memorial Medical Center
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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
サンプリング方法
調査対象母集団
被験者は、以下の適応症のために骨への軟部組織の再付着を必要とします:
- 肩 - バンカート修復のための嚢安定化、前肩不安定性、SLAP 損傷修復、嚢シフトまたは嚢ラブラル再建、上腕二頭筋腱固定術、腱板回旋筋腱板修復 (ノットレス アンカーのみ)
- 股関節 - 寛骨臼関節唇修復/再建
説明
包含基準:
被験者は、以下の適応症のために骨への軟部組織の再付着を必要とします:
- 肩 - バンカート修復のための嚢安定化、前肩不安定性、SLAP 損傷修復、嚢シフトまたは嚢ラブラル再建、上腕二頭筋腱固定術、腱板回旋筋腱板修復 (ノットレス アンカーのみ)
- 股関節 - 寛骨臼関節唇修復/再建
- -被験者は、EC承認のインフォームドコンセントフォームに署名することにより、研究への参加に同意しました。
- -被験者は手術時の年齢が18歳以上です。
- -必要なすべての研究訪問を喜んで行うことができます。
- 指示に従うことができる。
除外基準:
- -インプラント材料に対する既知の過敏症。 物質の過敏症が疑われる場合は、移植前に適切な検査を行い、過敏症を除外する必要があります。
- 嚢胞性変化や重度の骨減少症などの骨の病理学的状態。これにより、アンカーの確実な固定が損なわれます。
- -縫合による確実な固定を損なう可能性のある、付着する軟部組織の病理学的状態。
- 粉砕された骨表面。これにより、アンカーの確実な固定が損なわれます。
- 適切なアンカーサポートを排除する、または排除する傾向がある、または治癒を遅らせる物理的状態。
- 感染の存在。
- 治癒期間中に活動を制限したり、指示に従う被験者の能力や意欲を制限する状態。
- 現在、たばこ製品（紙巻たばこ、無煙たばこ、電子タバコ、電子たばこなど）を使用しています。
- 同時両側手術。
- -以前のMICRORAPTOR REGENESORB、MICRORAPTOR Knotless REGENESORB、またはMICRORAPTOR Knotless PEEK移植。
- -訪問1から30日以内、または研究中の別の臨床試験の治療期間への参加。
- 妊娠中または授乳中の女性。
- -治療への不十分なコンプライアンスの歴史。
- -関節腔で行われた以前の同側手術。
- -治験責任医師の意見では、研究への安全な被験者の参加を妨げる医学的または身体的状態の被験者。
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：他の
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
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MICROAPTOR™ REGENESORB™ 縫合糸アンカー
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Smith & Nephew MICROAPTOR™ REGENESORB™ Suture Anchor は、軟組織を骨に確実に取り付けることを目的とした固定装置です。
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MICROAPTOR™ Knotless REGENESORB™ 縫合糸アンカー
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MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor は、インサーター上のアンカーと縫合糸スレッダーからなる固定装置です。
アンカーは次のコンポーネントで構成されています: 近位アンカー本体 (REGENESORB™)、および非吸収性 PEEK (ポリエーテル エーテル ケトン) 遠位アンカー チップ。
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MICROAPTOR™ Knotless PEEK 縫合糸アンカー
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MICRORAPTOR™ ノットレス PEEK 縫合糸アンカーはクラス IIb 装置で、インサーター上のアンカーと縫合糸通し装置で構成されています。
アンカーは、次のコンポーネントで構成されています: 近位アンカー本体 (PEEK)、および非吸収性 PEEK 遠位アンカー チップ。
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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 |
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Repair Failure Rate at 6 Months
時間枠：6 months
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Repair failure at 6 months was determined by physician diagnosis of recurrent shoulder dislocation, subluxation, and patient symptoms (e.g., pain).
In the event of suspected repair failure, MRI or CT scan must confirm the root cause (i.e., intraarticular labrum failure or fixation repair failure) and assess glenoid bone loss.
The repair failure rate was defined as the number of participants with confirmed repair failure divided by the total number of participants in the study device group at the 6-month follow-up.
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6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Repair Failure Rate at 12 Months
時間枠：12 months
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Repair failure at 12 months was determined by physician diagnosis of recurrent shoulder dislocation, subluxation, and patient symptoms (e.g., pain).
In the event of suspected repair failure, MRI or CT scan must confirm the root cause (i.e., intraarticular labrum failure or fixation repair failure) and assess glenoid bone loss.
The repair failure rate was defined as the number of participants with confirmed repair failure divided by the total number of participants in the study device group at the 12-month follow-up.
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12 months
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Visual Analogue Scale (VAS) Pain Change From Baseline
時間枠：Baseline to 6 months, 12 months, and 24 months
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Pain was assessed using a Visual Analogue Scale (VAS) where participants indicated their pain level by marking a point that represented their perceived pain intensity.
Scores ranged from 0 to 100, with 0 representing no pain and 100 representing the worst imaginable pain (i.e., a worse outcome).
A decrease in VAS Pain score indicated a reduction in pain (i.e., a better outcome) and an increase indicated worsening in pain (i.e., a worse outcome).
The mean change in pain score was recorded on the VAS from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group.
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Baseline to 6 months, 12 months, and 24 months
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Repair Failure Rate at 24 Months (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY)
時間枠：24 months
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Repair failure at 24 months was collected only for participants that received the MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor.
Repair failure was determined by physician diagnosis of recurrent shoulder dislocation, subluxation, and patient symptoms (e.g., pain).
In the event of suspected repair failure, MRI or CT scan must confirm the root cause (i.e., intraarticular labrum failure or fixation repair failure) and assess glenoid bone loss.
The repair failure rate was defined as the number of participants with confirmed repair failure divided by the total number of participants in the study device group at the 24-month follow-up.
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24 months
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Anchor Absorption/Replacement by Bone (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY): Acetabular Labral Condition
時間枠：Baseline, 6 months, and 24 months
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Hip Magnetic Resonance Imagining (MRI) was performed on participants that received the MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor to determine anchor absorption/replacement by bone at baseline, 6 months, and 24 months based on acetabular labral condition classification. The number of participants acetabular labral condition was classified as one of the following:
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Baseline, 6 months, and 24 months
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Anchor Absorption/Replacement by Bone (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY): Joint Effusion
時間枠：Baseline, 6 months, and 24 months
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Hip Magnetic Resonance Imagining (MRI) was performed on participants that received the MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor to determine anchor absorption/replacement by bone at baseline, 6 months, and 24 months based on joint effusion classification. The number of participants joint effusion was classified as one of the following:
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Baseline, 6 months, and 24 months
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Anchor Absorption/Replacement by Bone (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY): Bone Marrow Edema
時間枠：Baseline, 6 months, and 24 months
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Hip Magnetic Resonance Imagining (MRI) was performed on participants that received the MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor to determine anchor absorption/replacement by bone at baseline, 6 months, and 24 months based on the presence of bone marrow edema.
The number of participants with bone marrow edema were categorized as 'Absent' or 'Present'.
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Baseline, 6 months, and 24 months
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Rowe Shoulder Score Change From Baseline (Shoulder Participants ONLY)
時間枠：Baseline to 6 months, 12 months, and 24 months
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The Rowe shoulder score for shoulder instability evaluated using a 3-item instrument completed by the investigator or qualified, delegated study staff. Its questions addressed the categories of shoulder stability (0 to 50 points), motion (0 to 20 points), and function (0 to 30 points). Scores ranged from 0 to 100 with a score of 90-100 points indicating an excellent evaluation, 75-89 points indicating a good evaluation, 51-74 points indicating a fair evaluation, and =< 50 points indicating a poor evaluation. An increase in Rowe score indicated reduced shoulder instability (i.e., a better outcome) and a decrease indicated worsening instability (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group. |
Baseline to 6 months, 12 months, and 24 months
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Western Ontario Shoulder Instability Index (WOSI) Score Change From Baseline (Shoulder Participants ONLY)
時間枠：Baseline to 6 months, 12 months, and 24 months
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Western Ontario Shoulder Instability Index (WOSI) was a participant completed instrument. Its categories included "physical symptoms", "sports, recreation, work", "pain", "lifestyle", and "emotion", with questions within each category scored from 0 to 100 using a visual analog scale. Scores were combined to produce an overall score that ranged from 0 to 2100 with a score of 0 indicating better shoulder function and 2100 indicating worse shoulder function. A decrease in WOSI score indicated improving shoulder function (i.e., a better outcome) and an increase indicated worsening shoulder function (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group. |
Baseline to 6 months, 12 months, and 24 months
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Constant-Murley Shoulder Scale Change From Baseline (Should Participants ONLY)
時間枠：Baseline to 6 months, 12 months, and 24 months
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Constant-Murley Shoulder (CMS) scale assesses four aspects related to shoulder pathology: pain, activities of daily living (ADL), range of motion (ROM), and strength. The total score ranged from 0 to 100, with a higher score indicating better shoulder function. An increase in CMS score indicated improving shoulder function (i.e., a better outcome) and a decrease indicated worsening function (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group. |
Baseline to 6 months, 12 months, and 24 months
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Hip Outcome Score Activities of Daily Living (HOS-ADL) Score Change in Baseline (Hip Participants ONLY)
時間枠：Baseline to 6 months, 12 months, and 24 months
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The Hip Outcome Score Activities of Daily Living (HOS-ADL) subscale consisted of 17 items that addressed specific activities related to hip function. Scores ranged from 0 to 100 with 0 representing the least function and 100 representing the most function. An increase in HOS-ADL score indicated improved hip function (i.e., a better outcome) and a decrease indicated worsening function (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group. |
Baseline to 6 months, 12 months, and 24 months
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Modified Harris Hip Score (mHHS) Change From Baseline (Hip Participants ONLY)
時間枠：Baseline to 6 months, 12 months, and 24 months
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Modified Harris Hip Score (mHHS) is a joint specific score covering domains of pain, function, functional activities, absence of deformity, and hip range of motion. Scores ranged from 0 to 100, with 0 representing worse disability and 100 representing less disability. An increase in mHHS indicated improved hip joint function (i.e., a better outcome) and a decrease indicated worsening function (i.e., a worse outcome). The mean change in score was recorded from baseline to each scheduled post-operative visit at 6 months, 12 months, and 24 months as specified depending on the treatment group. |
Baseline to 6 months, 12 months, and 24 months
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協力者と研究者
スポンサー
捜査官
- スタディチェア：Mary Ozokwere、Smith & Nephew, Inc.
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
本研究に関する用語
その他の研究ID番号
- 2018.20.SMD.MRPTKT.PRO
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
米国で製造され、米国から輸出された製品。
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。