NCT01670617Unknown不适用
A Stratified, Post-Market Study of DeNovo NT for the Treatment of Femoral and Patellar Articular Cartilage Lesions of the Knee
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 18
- 主要终点
- Improvement in KOOS scores
研究概览
简要总结
The purpose of this study is to evaluate the long-term relief of pain and return to function for patients receiving DeNovo NT for cartilage lesions in the knee. DeNovo NT is a marketed product and has been used in more than 7,500 patients over the last 7 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary signature of the IRB approved Informed Consent,
- •Male or female subjects between the ages of 18 to 55 years,
- •If female: Actively practicing a contraception method and willing to continue for a minimum of 1 year postoperatively, practicing abstinence and willing to continue for a minimum of 1 year postoperatively, or sterile
- •One or two contained lesion(s) of the femur or patella ≥ ICRS Grade 3 or OCD lesions with healed bone base with no loss of bone greater than 6mm
- •Has peripheral cartilage debridement to healthy cartilage that results in at least one lesion with an area of ≥ 2 cm2 and ≤ 7.5 cm2,
- •Lesion(s) to be treated must be contained/shouldered > 70% of the periphery,
- •Ligaments in the affected knee are stable,
- •Ipsilateral knee compartment has intact menisci
- •The contralateral knee is asymptomatic, stable, and fully functional,
- •Is refractory to conservative non-surgical management or minimal surgical intervention and ≥ 3 months from the start of either treatment,
- •Must record a response, at the preoperative study visit, of moderate to extreme pain for any one of the KOOS Pain Scale questions, P2 through P
- •Must be physically and mentally willing and able, in the Investigator's opinion at the time of enrollment, to be compliant with the protocol
排除标准
- •Clinical disease diagnosis of the indexed affected joint that includes
- •Osteoarthritis or avascular necrosis,
- •Rheumatoid arthritis, or history of septic or reactive arthritis,
- •Gout or a history of gout or pseudogout in the affected knee,
- •Bipolar articular cartilage involvement (or kissing lesions)
- •Has more than two clinically relevant chondral lesion(s) on the index knee,
- •Osteochondritis dissecans of the knee with significant bone loss
- •Associated damage to the underlying subchondral bone requiring bone graft,
- •Has well-defined subchondral cyst(s),
- •Has current or impending subchondral avascular necrosis,
- •History of secondary arthropathies (i.e., sickle cell disease, hemochromatosis, or autoimmune disease),
- •Uncontrolled diabetes,
- •Displays a high surgical risk due to unstable cardiac and/or pulmonary disease,
- •Has HIV or other immunodeficient state
- •Is at substantial risk for the need of organ transplantation
- •Is pregnant or breast-feeding,
- •Body Mass Index >35 (BMI=kg/m2),
- •Is participating concurrently in another clinical trial
- •Is receiving prescription pain medication other than NSAIDs or acetaminophen for conditions unrelated to the index knee condition, chronic use of anticoagulants, or taking corticosteroids,
- •Has a neuromuscular, neurosensory, or musculoskeletal deficiency that limits the ability to perform objective functional assessment of either knee,
- •Active joint infection or history of chronic joint infection at the surgical site,
- •Prior total meniscectomy of either knee,
- •Has severe patellofemoral malalignment/maltracking or patellar instability
- •Radiographically has >5 degrees of malalignment
- •Has received, within the past 3 months HA or cortisone injections in knee,
- •Has undergone prior tendon repair, meniscus repair, ligament repair or distal realignment/osteotomy surgery in the index knee, < 6 months prior to surgery,
- •Failed marrow stimulation or ACI treatment performed < 12-mo before baseline,
- •Index knee has been surgically treated for cartilage repair with OATs, mosaicplasty or osteochondral allograft,
- •Involves concomitant procedures in the affected knee with the exception of incidental loose body removal, debridement, synovectomy, retinacular release, and/or partial meniscectomy
- •Has contraindications for Magnetic Resonance Imaging (MRI),
- •Has an allergy to Polymyxin B sulfate or Bacitracin antibiotics,
- •Is receiving workman's compensation or currently involved in litigation relating to the index knee
研究组 & 干预措施
DeNovo NT Graft
Other
DeNovo NT Graft stratified by lesion location - femur or patella
干预措施: Particulated Juvenile Articular Cartilage (Other)
结局指标
主要结局
Improvement in KOOS scores
时间窗: Between baseline and 24 months post surgery
Improvement in Knee Injury and Osteoarthritis Outcomes Survey (KOOS) scores
次要结局
- Incidence and time to reoperation/revision(5 years)
- Mean IKDC Knee Examination grades(Annually to 5 years post surgery)
- MRI Evaluation(Preop, 12 Months and 24 Months post surgery)
- Incidence of adverse events(Annually to 5 years post surgery)
- X-ray Evaluation(Preop, 12 months and 24 months post surgery)
研究者
研究点 (18)
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