高グレード部分層涙液における REGENETEN™ 生体誘導インプラント システムの使用 (IMPACT)
高度部分厚涙液の治療における再吸収性コラーゲンインプラントの安全性と有効性の評価。前向き、多施設、無作為化、対照試験 (IMPACT 研究)
The purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique 'Completion and Repair' for surgically treating partial-thickness rotator cuff tears.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
The primary objective of this study is to evaluate the functional recovery of patients with high grade (>50%) partial thickness tears at 3 months when treated with either Isolated Bioinductive Repair (IBR) or Completion and Repair (CAR).
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Mary Ozokwere
- 電話番号：+1 469-560-0727
- メール：Mary.Ozokwere@smith-nephew.com
研究連絡先のバックアップ
- 名前：Judith Horner
- 電話番号：+44 (0) 7834614336
- メール：judith.horner@smith-nephew.com
研究場所
-
-
Georgia
-
Rome、Georgia、アメリカ、30165
- 募集
- Harbin Clinic
-
主任研究者：
- Brandon Bushnell
-
コンタクト：
- Terri Brannon
-
-
Illinois
-
Rockford、Illinois、アメリカ、61107
- 募集
- OrthoIllinois LTD
-
主任研究者：
- Scott Trenhaile
-
コンタクト：
- Catherine Ayala
-
-
Maryland
-
Baltimore、Maryland、アメリカ、21215
- 引きこもった
- Sinai Hospital Baltimore
-
-
Ohio
-
Garfield Heights、Ohio、アメリカ、44125
- 引きこもった
- Cleveland Clinic - Sports Health
-
-
Pennsylvania
-
Pittsburgh、Pennsylvania、アメリカ、15213
- 募集
- University of Pittsburgh
-
主任研究者：
- Albert Lin
-
コンタクト：
- Alec Howard
-
-
Texas
-
Bedford、Texas、アメリカ、76021
- 積極的、募集していない
- Texas Orthopedic Specialists
-
The Woodlands、Texas、アメリカ、77385
- 引きこもった
- Houston Methodist The Woodlands
-
-
Wisconsin
-
Ashland、Wisconsin、アメリカ、54806
- 引きこもった
- Memorial Medical Center
-
-
-
-
-
Bath、イギリス
- 募集
- Sulis Hospital
-
主任研究者：
- Andrew Chambler
-
Bristol、イギリス
- 募集
- North Bristol NHS Trust
-
コンタクト：
- Steven Barnfield
-
主任研究者：
- Iain Packham
-
Salford、イギリス、M6 8HD
- 引きこもった
- Northern Care Alliance NHS Foundation Trust
-
-
Surrey
-
Chertsey、Surrey、イギリス、KT16 0PZ
- 募集
- Ashford & St Peter's Hospitals NHS Foundation Trust
-
主任研究者：
- Ali Narvani
-
コンタクト：
- Timnit Tekie
-
-
-
-
-
Milan、イタリア
- 募集
- IRCCS Istituto Ortopedico Galeazzi,
-
コンタクト：
- Vincenzo Guarrella
-
主任研究者：
- Ettore Taverna
-
Roma、イタリア
- 募集
- Fondazione Policlinico Universitario Campus Bio-Medico
-
コンタクト：
- Giuseppe Longo
-
主任研究者：
- Giuseppe Longo
-
-
-
-
Victoria
-
Richmond、Victoria、オーストラリア、3121
- 募集
- OrthoSport Victoria
-
主任研究者：
- Soong Chua
-
コンタクト：
- Haydn Klemm
-
-
-
-
Alberta
-
Calgary、Alberta、カナダ、T2R 2G5
- 募集
- Access Orthopaedics
-
コンタクト：
- Kristie More
-
主任研究者：
- Ian Lo
-
-
Manitoba
-
Winnipeg、Manitoba、カナダ
- 積極的、募集していない
- Pan Am Clinic
-
-
Ontario
-
Hamilton、Ontario、カナダ
- 募集
- Research St. Joseph's
-
主任研究者：
- Moin Khan
-
コンタクト：
- Danielle Dagher
-
-
-
-
-
Madrid、スペイン、28034
- 募集
- Hospital Ramón y Cajal
-
コンタクト：
- Miguel Angel Ruiz Iban
-
主任研究者：
- Miguel Angel Ruiz Iban
-
Madrid、スペイン、28040
- 募集
- Hospital Fundación Jiménez Díaz
-
コンタクト：
- Cristina Delgado del Cano
-
主任研究者：
- Emilio Calvo
-
-
参加基準
適格基準
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:
- The subject must provide written informed consent.
- Subject is > eighteen (18) years of age (no upper limit).
- Subject has an isolated high-grade (>50% or >6mm) (Ellman grade III) partial thickness tear of supraspinatus or supraspinatus with infraspinatus.
- Subject has failed a minimum of 3 months of conservative management for treatment of partial thickness rotator cuff tear.
- Subject willing and able to make all required study visits.
- Subject able to follow instructions and deemed capable of completing all study questionnaires.
Exclusion Criteria:
- Subjects with insufficient tendon tissue quality for management and protection of the tendon injury using the isolated REGENETEN Bioinductive Implant system.
- Subjects where the prescribed Physical Therapy guidelines stated in the protocol are not suitable for their rehabilitation.
- Subjects with Samilson-Prieto osteoarthritis grade 2 and greater.
- Subjects with current or prior infection of the ipsilateral shoulder.
- Subjects with known hypersensitivity to bovine-derived materials.
- Subjects with known inflammatory arthropathy, history of inflammatory arthropathy, chronic joint disease or chronic pain of upper extremities (shoulder(s), arm(s)).
- Subjects with prior shoulder surgery on index shoulder, including subacromial decompression, biceps tenodesis/tenotomy, and acromioclavicular joint (ACJ) excision/distal clavicle excision (DCE).
- Subjects with a planned surgery on the contra-lateral shoulder within the study period.
- Systemic steroid use (oral, IV) or local steroid injection within 3 months of the date of surgery.
- Subjects with a full thickness rotator cuff tear.
- Subjects with a subscapularis tear requiring repair.
- Subjects requiring a concomitant labral fixation procedure, concomitant surgery for bone defects requiring bone implantation or for superior labral tear from anterior to posterior (SLAP).
- Subjects requiring a concomitant os acromiale fixation procedure.
- Subjects with glenohumeral joint instability (multiple dislocations/subluxations).
- Subjects with condition(s) that contraindicate or complicate outcomes of Isolated Bioinductive Repair or completion and repair e.g., > Hamada 3 rotator cuff arthropathy on X-ray, Goutallier atrophy > Grade 3, proximal humeral fracture or scapular fracture, avascular necrosis of the humeral head.
- Subjects with neurologic conditions effecting either upper extremity.
- Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications.
- Subjects who are pregnant or breast feeding.
- Subjects who are currently involved in any injury litigation relating to the index shoulder.
- Subjects with current workers compensation claim.
- Subjects who are enrolled, or plan to enroll, in another clinical trial during this study that would affect the outcomes of this study.
- Subjects with a history of poor compliance with medical treatment, physical therapy (PT)/rehabilitation, or clinical study participation.
- Subject who, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, and drug or alcohol abuse.
- Subjects who do not meet the indication or are contraindicated according to specific Smith+Nephew REGENETEN System's Instructions for Use (IFUs).
- Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55.
- Subjects who have participated previously in this clinical trial and who have healed or been withdrawn
- Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
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：ランダム化
- 介入モデル：並列代入
- マスキング：独身
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Isolated Bioinductive Repair
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. |
Isolated Bioinductive repair with REGENETEN™ Bioinductive Implant
他の名前：
|
|
アクティブコンパレータ：Completion and Repair
Surgical treatment of partial-thickness rotator cuff tears using the standard surgical technique 'Completion and Repair'. |
Standard surgical repair using the 'Completion and Repair' technique. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Western Ontario Rotator Cuff (WORC)
時間枠：Change from baseline to 3 months post-intervention
|
The WORC Index is self-administered, and includes a 5 different domains (physical symptoms, sports and recreation, work, social function, and emotions). Each question uses a visual analog scale (VAS) representing a 100-point scale ranging from 0 to 100. The maximum score is 2100 (worst possible symptoms). Zero (0) represents no symptoms at all. The final score can also be presented as a percentage by subtracting the total from 2100, dividing by 2100, and multiplying by 100. This will give you an overall percentage. The total final WORC Index scores can, therefore, range from 0% (lowest functional status level) to 100% (highest functional status level). |
Change from baseline to 3 months post-intervention
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Western Ontario Rotator Cuff (WORC)
時間枠：Pre-op, 6 weeks, 3, 6, 12 and 24 months
|
The WORC Index is self-administered, and includes a 5 different domains (physical symptoms, sports and recreation, work, social function, and emotions). Each question uses a visual analog scale (VAS) representing a 100-point scale ranging from 0 to 100. The maximum score is 2100 (worst possible symptoms). Zero (0) represents no symptoms at all. The final score can also be presented as a percentage by subtracting the total from 2100, dividing by 2100, and multiplying by 100. This will give you an overall percentage. The total final WORC Index scores can, therefore, range from 0% (lowest functional status level) to 100% (highest functional status level). |
Pre-op, 6 weeks, 3, 6, 12 and 24 months
|
|
Constant-Murley Score
時間枠：Pre-Op, 3, 6, 12 and 24 months
|
The Constant-Murley Score is a validated assessment of pain and shoulder functionality. The Constant Score is divided into 4 subscales: pain (15 points; VAS score range of 0-15), activities of daily living (20 points; range 0=worst, 5=best), strength (25 points; 1 point given per 0.5 kg of weights raised), and range of motion - forward flexion, external rotation, abduction and internal rotation of the shoulder (40 points; range 0=worst, 10=best). The higher the score, the higher the quality of function. |
Pre-Op, 3, 6, 12 and 24 months
|
|
Subjective Shoulder Value (SSV) score
時間枠：Pre-Op, 6 weeks, 3, 12 and 24 months
|
The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100% (0% to 100% scale with 100% being normal). |
Pre-Op, 6 weeks, 3, 12 and 24 months
|
|
EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS & index scores
時間枠：Pre-Op, 3 and 6 weeks, 3, 6, 12 and 24 months
|
To assess the subject's health state. The EQ-5D-5L is composed of the EQ- 5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. For instance, 'slight problems' (e.g. 'I have slight problems in walking about') is always coded as '2'. The digits for the five dimensions are combined in a 5-digit code. The EQ- 5D-5L index value is derived by using the vendor supplied calculator to convert each 5-digit EQ- 5D-5L profile. The EQ VAS corresponds to a 20 cm vertical, visual analogue scale ranging from 'the best health you can imagine' to 'the worst health you can imagine'. A higher number is a better outcome. |
Pre-Op, 3 and 6 weeks, 3, 6, 12 and 24 months
|
|
Change in Western Ontario Rotator Cuff (WORC)
時間枠：Change from Pre-op to 6 weeks, 3, 6, 12 and 24 months
|
The WORC Index is self-administered, and includes a 5 different domains (physical symptoms, sports and recreation, work, social function, and emotions). Each question uses a visual analog scale (VAS) representing a 100-point scale ranging from 0 to 100. The maximum score is 2100 (worst possible symptoms). Zero (0) represents no symptoms at all. The final score can also be presented as a percentage by subtracting the total from 2100, dividing by 2100, and multiplying by 100. This will give you an overall percentage. The total final WORC Index scores can, therefore, range from 0% (lowest functional status level) to 100% (highest functional status level). |
Change from Pre-op to 6 weeks, 3, 6, 12 and 24 months
|
|
Change in Constant-Murley Score
時間枠：Change from Pre-Op to 6 weeks, 3, 12 and 24 months
|
The Constant-Murley Score is a validated assessment of pain and shoulder functionality. The Constant Score is divided into 4 subscales: pain (15 points; VAS score range of 0-15), activities of daily living (20 points; range 0=worst, 5=best), strength (25 points; 1 point given per 0.5 kg of weights raised), and range of motion - forward flexion, external rotation, abduction and internal rotation of the shoulder (40 points; range 0=worst, 10=best). The higher the score, the higher the quality of function. |
Change from Pre-Op to 6 weeks, 3, 12 and 24 months
|
|
Change in Subjective Shoulder Value (SSV) score
時間枠：Change from Pre-Op to 6 weeks, 3, 12 and 24 months
|
The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100% (0% to 100% scale with 100% being normal). |
Change from Pre-Op to 6 weeks, 3, 12 and 24 months
|
|
Percent Achieving Minimal Clinically Important Difference (MCID) for Constant-Murley Score
時間枠：Pre-Op, 3, 6, 12 and 24 months
|
The Constant-Murley Score is a validated assessment of pain and shoulder functionality. The Constant Score is divided into 4 subscales: pain (15 points; VAS score range of 0-15), activities of daily living (20 points; range 0=worst, 5=best), strength (25 points; 1 point given per 0.5 kg of weights raised), and range of motion - forward flexion, external rotation, abduction and internal rotation of the shoulder (40 points; range 0=worst, 10=best). The higher the score, the higher the quality of function. |
Pre-Op, 3, 6, 12 and 24 months
|
|
Percent Achieving MCID for Western Ontario Rotator Cuff (WORC)
時間枠：Pre-op, 6 weeks, 3, 6, 12 and 24 months
|
The WORC Index is self-administered, and includes a 5 different domains (physical symptoms, sports and recreation, work, social function, and emotions). Each question uses a visual analog scale (VAS) representing a 100-point scale ranging from 0 to 100. The maximum score is 2100 (worst possible symptoms). Zero (0) represents no symptoms at all. The final score can also be presented as a percentage by subtracting the total from 2100, dividing by 2100, and multiplying by 100. This will give you an overall percentage. The total final WORC Index scores can, therefore, range from 0% (lowest functional status level) to 100% (highest functional status level). |
Pre-op, 6 weeks, 3, 6, 12 and 24 months
|
|
Percent Achieving MCID for Subjective Shoulder Value (SSV) score
時間枠：Pre-Op, 6 weeks, 3, 12 and 24 months
|
The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100% (0% to 100% scale with 100% being normal). |
Pre-Op, 6 weeks, 3, 12 and 24 months
|
|
Patient Satisfaction
時間枠：6 weeks, 3, 6, 12 and 24 months
|
Comprise of 2 questions:
Question rated by the patient with Strongly Agree, Agree, Neither Agree nor Disagree, Disagree, Strongly Disagree. |
6 weeks, 3, 6, 12 and 24 months
|
|
Pain, Visual analog scale (VAS) Score
時間枠：Pre-Op, 3 and 6 weeks, 3, 12 and 24 months
|
Pain is assessed on a 100-point scale ranging from 0 to 100, with zero (0) representing no pain and 100 representing the worst pain imaginable. |
Pre-Op, 3 and 6 weeks, 3, 12 and 24 months
|
|
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Sugaya Score
時間枠：12 months
|
The Sugaya score is classified into 5 categories: Type I to Type V. Type I indicates sufficient thickness with homogenously low intensity. Type II indicates sufficient thickness with partial high intensity. Type III indicates insufficient thickness without discontinuity. Type IV indicates presence of a minor discontinuity, suggesting a small full-thickness tear. Type V indicates the presence of a major discontinuity, suggesting a medium or large full-thickness tear. |
12 months
|
|
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via MRI assessment of percent filling
時間枠：12 months
|
Percent tissue infil is graded at site of original tear and classified as 0% to < 25%, 25% to < 50%, 50% to < 75%, 75% to < 100% and 100%. |
12 months
|
|
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via MRI assessment of the signal intensity pattern
時間枠：12 months
|
The Signal Intensity Pattern will be graded into 3 categories. Type I: Heterogeneous high signal intensity with fluid-like bright foci, Type II: Heterogeneous high signal intensity without fluid-like bright foci, Type III: Heterogeneous or homogeneous low signal intensity. |
12 months
|
|
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Rotator cuff tendon thickness
時間枠：12 months
|
Tendon thickness will be measured in millimeters (mm). |
12 months
|
|
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Goutallier classification
時間枠：12 months
|
The Goutallier classification will be used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranges from a grade of 0 indicating a completely normal muscles without any fatty streaks to a grade of 4 which indicates that more fat than muscle is present. |
12 months
|
|
Incidence of Revision Surgery
時間枠：1, 3 and 6 weeks, 3, 6, 12 and 24 months
|
Number of subjects requiring revision surgery |
1, 3 and 6 weeks, 3, 6, 12 and 24 months
|
|
Time to return to work
時間枠：Up to 24 months
|
Number of weeks taken to return to work following surgery |
Up to 24 months
|
|
Time to return to driving
時間枠：Up to 24 months
|
Number of weeks taken to return to driving following surgery |
Up to 24 months
|
|
Time to return to sports
時間枠：Up to 24 months
|
Number of weeks taken to return to sport following surgery |
Up to 24 months
|
|
Total operative time
時間枠：Inter-operative time
|
Time expressed in minutes |
Inter-operative time
|
|
Physical Therapy Utilization
時間枠：Up to 24 months
|
Number visits following index surgery |
Up to 24 months
|
|
Cumulative days of opioid use
時間枠：Day 1-14
|
Self-reported opioid use diary completed by the patient on a daily basis, from day 0-14, documenting opioid use. Consumption daily (YES/NO) x14 days, 'Have you taken any opioid medication today for shoulder pain?' |
Day 1-14
|
|
Duration of shoulder immobilization following index surgery
時間枠：1, 3 and 6 weeks, 3 months
|
Number of days |
1, 3 and 6 weeks, 3 months
|
協力者と研究者
捜査官
捜査官
- スタディチェア：Laura Mills、Smith & Nephew, Inc.
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
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
その他の研究ID番号
- REGENETEN.2021.04
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?
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
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。