膝の深部骨軟骨病変の治療のためのMaioRegen Prime研究 (OSTEOCONFIRM)
膝関節の骨軟骨病変の治療におけるMaioRegenTM Prime対デブリードマン（外科的標準治療（SSOC））の多施設前向き無作為化研究 - OSTEOCONFIRM研究
The present study aims to compare the efficacy and the safety of MaioRegen Prime to Debridement (SSOC) in patients with deep osteochondral lesions of the knee joint. The foreseen population involves patients with osteochondral lesions with different etiology, dimension, shape, and location.
The evaluation will be performed through clinical, subjective and objective assessments.
調査の概要
詳細な説明
This is multicenter, prospective, randomized clinical trial, subjects will be randomized (2:1) to MaioRegen Prime or debridement.
All randomized patients will be followed with post-operative visits at 15 days, 6 weeks, 3, 6, 12, 18 and 24 months after surgery and annually post-24 months visit (until last patient reaches 24 months).
During screening period and at follow-up visits commonly used specific scores will be evaluated: IKDC Subjective Knee Evaluation Form, IKDC Knee Examination Form, KOOS, Tegner Score, VAS pain, PROMIS-29, ICRS Cartilage Repair Assessment and MRI related scores.
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：Simal Trikam, Clinical Trial Manager
- 電話番号：+44 7889983972
- メール：strikam@mcra.com
研究連絡先のバックアップ
- 名前：Roberta Miale, MEng
- 電話番号：+39 0546645438
- メール：roberta.miale@finceramica.it
研究場所
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California
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La Mesa、California、アメリカ、91942
- まだ募集していません
- Grossmont Orthopaedic Medical Group
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主任研究者：
- Scott Hacker
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Colorado
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Steamboat Springs、Colorado、アメリカ、80487
- 募集
- Steamboat Orthopaedic & Spine Institute
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主任研究者：
- Alexander Meininger
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Illinois
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Oak Brook、Illinois、アメリカ、60523
- 募集
- Genesis Orthopedics & Sports Medicine
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主任研究者：
- Hythem Shadid
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Michigan
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Ann Arbor、Michigan、アメリカ、48109
- 募集
- University of Michigan Med school
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主任研究者：
- John Grant
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Ohio
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Cincinnati、Ohio、アメリカ、45219
- 募集
- University of Cincinnati Medical Center
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主任研究者：
- Brian Grawe
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Columbus、Ohio、アメリカ、43210
- 募集
- Ohio State University
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主任研究者：
- David Flanigan
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Oregon
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Portland、Oregon、アメリカ、97239
- 募集
- Oregon Health & Science University in Portland
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主任研究者：
- Dennis Charles Crawford
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Tennessee
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Jackson、Tennessee、アメリカ、38305
- 募集
- Clinical Research Solutions
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主任研究者：
- Jason Hutchison
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Texas
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Rockwall、Texas、アメリカ、75087
- 募集
- North Texas Medical Research Institute
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主任研究者：
- Mohammad Umar Burney
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BO
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Bologna、BO、イタリア、40136
- 募集
- IRCCS Rizzoli Orthopedic Institute
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主任研究者：
- Stefano Zaffagnini
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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
受講資格のある性別
説明
Inclusion Criteria:
- Informed consent prior to any study-related procedures;
- Male or female patients aged between 18 and 60 years (inclusive);
- Body Mass Index (BMI) ≤ 35;
- Up to 3 treatable osteochondral lesions localized in femoral condyles and/or trochlea (the patient might have other lesion in other parts of the joint, but they should not be more severe than ICRS Grade II lesions as determined by baseline MRI);
- Knee osteochondral lesion(s) (Grade IVa and IVb according to ICRS Classification) or not re-fixable knee Osteochondritis Dissecans lesions as determined by baseline MRI;
- Lesions with an overall treatable area 1-7 cm2 (as determined by baseline MRI). In case of multiple lesions (maximum 3 lesions) in the same knee compartment a minimum distance of 3 mm is required);
- IKDC Subjective score at baseline (pre-op evaluation) is less than 70;
- Non-responsive to physical therapy for at least 6 weeks;
- Patients physically and mentally willing and able to comply with the post-operative rehabilitation protocol and scheduled clinical and radiographic visits.
Exclusion Criteria:
- IKDC subjective score at Baseline is more than or equal to 70;
- KOOS Pain Subscale score at baseline is less than 20 or more than 65 (scale: maximum pain = 0, pain free = 100);
- Osteochondral tibial plateau and/or patella defects;
- Patients affected by advanced osteoarthritis in the index knee (Kellgren and Lawrence classification 3 or 4);
- Bony defect depth deeper than 5 mm, according to baseline MRI, measured from the original subchondral bone plate level;
- Uncontained defects: lack of vital bone wall at least 2 mm thick, completely surrounding the lesion - based on MRI;
- Patients with untreated patellofemoral malalignment or who have undergone realignment procedures within 6 months;
- Patients with bone fracture or uncorrected malalignment more than 5 degrees varus or valgus according to standing X-ray.
- Patients previously treated for total or partial meniscectomy in the specific index knee compartments (more than 50% of the meniscus in the index compartments is missing);
- Patient requiring total or partial meniscectomy to be performed concomitantly, involving more than 50% of one or both menisci in the index knee compartment (lack of functional remaining meniscus, at least 5mm rim at the end of the procedure); and patient requiring ligamentoplasty and high tibial osteotomy (HTO) to be performed concomitantly;
- Untreated knee ligament instability or treated within 6 months;
- Kissing (counterposed) osteochondral lesions;
- Significant instability of the index knee according to IKDC Knee Examination Form 2000: Grade C (abnormal) or D (severely abnormal).
- Patients affected by any concomitant painful or disabling disease of the spine, hips, or lower limbs, including the contralateral knee, that would interfere with the evaluation of the index knee;
- Patients affected by bilateral knee lesions that need treatment;
- Intra-articular steroid injections within 3 months;
- Any previous cartilage repair procedure (such as: microfracture, Osteochondral autograft transplantation system (OATS), Autologous Matrix Induced Chondrogenesis, (AMIC), Autologous Chondrocyte Implantation (ACI) with or without use of a scaffold (matrix) in the index knee within one year or debridement within 6 months;
- Patients affected by osteoporosis (established through x-ray tests, called DEXA scans, bone density, etc. Criteria for osteoporosis: T-score is < - 2.5 SD), chondrodysplasia, or osteogenesis imperfecta;
- Patients affected by known allergy to equine collagen or calcium-phosphates;
- Patients who underwent chemotherapy in the past 12 months;
- Patients with a known history of any significant systemic disease (such as but not limited to: HIV, hepatitis, HTLV, syphilis, coagulopathies, insulin dependent diabetes mellitus etc.) or affected by a significant malignancy;
- Participation in other clinical trials within 90 days prior to the study or concurrent with the study;
- Patient who is pregnant (or intends to become pregnant within one-year post-op) or breastfeeding;
- Known drugs or alcohol abuse;
- Any evidence of active infection anywhere in the body. Urinary Tract Infection (UTI) patients can be included following antibiotic treatment, and provided that two consecutive cultures are negative (taken within at least 2 weeks of each other);
- Any known history of intra-articular or osseous infection of the index knee;
- Patients affected by a known history of inflammatory arthropathy or crystal-deposition arthropathy;
- Prisoners;
- The existence of any surgical or medical condition that, in the judgement of the Investigator, might compromise patient safety or the outcome of the study;
- Any medical conditions or implants that would prevent the participant from undergoing an MRI, including but not limited to pacemakers, clips, cochlear implants, or metal shrapnel.
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：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 |
|---|---|
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実験的：MaioRegen Prime
Medical Device: MaioRegen Prime implant |
three layered biomimetic osteochondral scaffold implant for osteochondral lesions of the knee |
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アクティブコンパレータ：Surgical Standard of Care (SSOC)
Debridement |
Debridement |
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 |
|---|---|---|
|
Superiority of MaioRegen Prime vs Debridement
時間枠：baseline, 24 months
|
The primary endpoint is the success rate defined as a composite binary endpoint, where a patient is a success if they meet all of the following criteria:
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baseline, 24 months
|
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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24ヶ月の追跡期間中のMaioRegen治療またはデブリードマン治療に関連する重篤な有害事象のない患者の割合
時間枠：ベースライン、24ヶ月
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ベースライン、24ヶ月
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MaioRegen治療またはデブリードマン治療後の24ヶ月追跡期間における関連再介入のない患者の割合
時間枠：ベースライン、24か月
|
ベースライン、24か月
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International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score at 24 months of MaioRegen Prime compared to debridement
時間枠：baseline, 24 months
|
Subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathologies. All questions examines 3 categories: symptoms, sports activity, and knee function. The IKDC Subjective Knee Evaluation Form is graded by adding the results of each item's scores, and then converting the result to a scale from 0 to 100. Higher scores indicate higher levels of function and lower levels of symptoms, (i.e., a better outcome). |
baseline, 24 months
|
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Rate of responder in IKDC Subjective Knee Evaluation at 24 months of MaioRegen Prime compared to debridement as defined as improvement in IKDC Subjective Knee Evaluation of ≥15 points
時間枠：baseline, 24 months
|
The new IKDC Subjective Knee Evaluation Form, published in 2000, is considered one of the most reliable assessment tools in the evaluation of knee pathologies. All questions examines 3 categories: symptoms, sports activity, and knee function. The IKDC Subjective Knee Evaluation Form is graded by adding the results of each item's scores, and then converting the result to a scale from 0 to 100. Higher scores indicate higher levels of function and lower levels of symptoms, (i.e., a better outcome). |
baseline, 24 months
|
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Change from baseline in average overall KOOS score (Knee Injury and Osteoarthritis Outcome Score)
時間枠：baseline, 12, 18, and 24 months
|
KOOS score consists of 5 subscales and covers: pain (9 items), symptoms (7 items, two of which are related to stiffness), functions and activities of daily living (17 items), physical function, sports and leisure activities (5 items) and quality of life in relation to the knee (4 items). Each question uses a 0 (no problem/difficulty) to 4 (extreme problem/difficulty) response, which is then converted into the final 0-100 score for each subscale, indicating the percentage of the total possible score achieved, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome). |
baseline, 12, 18, and 24 months
|
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Change from pre-injury and from baseline in Tegner score
時間枠：baseline, 12 months, 18 months, 24 months
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Tegner activity level scale allows to know the level of physical activity carried out by the patients. Tegner's activity scale classifies the activity according to work and sports activities on a scale from 0 to 10, where 0 is being on sick leave/disabled due to knee issues, and 10 is elite, international competitive sports. |
baseline, 12 months, 18 months, 24 months
|
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Change from baseline in IKDC (International Knee Documentation Committee) Knee Examination Objective Form
時間枠：baseline, 12 months, 18 months, 24 months
|
The IKDC objective examination form uses a 0-100 scale, calculated by summing seven parameters related to knee function. The presence of effusions and degree of knee motion are assessed; the worst value of any of these parameters determines the final IKDC grade. There are four grades (A, B, C, D) that identify a knee rated as normal, near normal, abnormal, and severely abnormal, respectively. |
baseline, 12 months, 18 months, 24 months
|
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Change from baseline in VAS (visual analogue scale) pain
時間枠：baseline, 12 months, 18 months, 24 months
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The VAS scale is a 0-cm line tool to measure pain intensity, with "no pain" at 0 and "worst pain imaginable" at 10, where patients mark their pain level |
baseline, 12 months, 18 months, 24 months
|
|
PROMIS-29 (Patient-Reported Outcomes Measurement Information System): Patient's QOL (quality of life) improvement
時間枠：baseline, 12 months, 18 months and 24 months
|
The PROMIS-29 uses a T-score metric (mean 50, SD 10) to assess 7 domains (Physical Function, Fatigue, Depression, Anxiety, Pain Interference, Sleep Disturbance, and Social Participation) with 4 questions with an additional pain intensity numeric rating scale (NRS, 0-10 score). There is no total score, but each axis forms its own score. |
baseline, 12 months, 18 months and 24 months
|
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MRI evaluation: MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) 2.0 Knee Score
時間枠：baseline, 12 months, 24 months
|
MOCART 2.0 score allows the assessment of both cartilage tissue repair and the structures surrounding it. It is a 0-100 point MRI-based system for evaluating cartilage repair, updating the original MOCART by focusing on nine key variables like defect filling (in 25% increments), integration to native cartilage, surface, signal intensity, bony changes (overgrowth/defect), marrow edema, and subchondral cysts. 100 represents the best score and a score of 0 represents the worst score. |
baseline, 12 months, 24 months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Safety Outcome
時間枠：24 monhs
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Adverse Events rate per type, severity, seriousness, and relatedness to the treatment, including Serious Adverse Events and Serious Adverse Device Effect, Adverse Device Effect, Unanticipated Adverse Device Effect, Re-operations, Complaint and Treatment Failures up to 24 months will be evaluated and adjudicated by CEC members. |
24 monhs
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研究の完了 (推定)
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QC基準を満たした最初の提出物
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