NL-OMON41787已完成不适用
Evaluation of an Acellular Osteochondral Graft for Cartilage LEsions European Post Market Study - The EAGLE European Post Market Study
DSM Biomedical0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. The patient is * 18 years old and skeletally mature (i.e. closed epiphyses).
- •2. The patient is male or a non-pregnant female who does not intend to become pregnant during the next 12 months.
- •3. The patient has a pre-procedure KOOS Pain subscale score is * 70.
- •4. The patient has an ICRS grade 3 or 4 focal articular cartilage lesion on the medial femoral condyle, lateral femoral condyle or trochlea, which measures 15mm in diameter. Note: only one knee per patient may be treated with BioMatrix CRD.
- •5. The cartilage lesion is amenable to treatment with a single BioMatrix CRD or an osteochondral autograft. Note: when an osteochondral autograft is harvested to repair the cartilage lesion, the harvest site defect is to be filled with BioMatrix CRD.
- •6. The patient has >= 50% of the meniscus remaining bilaterally with a stable rim.
- •7. The patient has the mental capacity and the willingness to comply with the post-operative rehabilitation plan, specified follow-up evaluations and can be contacted by telephone by site personnel.
- •8. The patient is willing and able to sign the informed consent document.
排除标准
- •1. The patient is contraindicated for MRI (i.e. pacemaker, defibrillator, cochlear
- •2. The patient has had a previous cartilage repair procedure (i.e., microfracture, OATS, ACI) at the intended BioMatrix CRD implantation site. Note: patients having prior debridement only at the intended BioMatrix CRD implantation site are eligible.
- •3. The patient had surgery in the injured knee within the last 6 months.
- •4. The patient has clinically significant (> 5 degrees) varus or valgus malalignment in either knee. Note: concurrent osteotomy is permissible.
- •5. The patient has >= grade 2 joint space narrowing on the Kellgren-Lawrence scale.
- •6. The patient has documented history or peri-operative diagnosis of osteoarthritis in the injured knee.
- •7. The patient has inflammatory arthropathy (i.e., rheumatoid arthritis, systemic lupus or active gout) or any synovial proliferative disorder. Note: patients noted to have pseudogout are eligible.
- •8. The patient has osteomyelitis or other active infection in either lower limb.
- •9. The patient has had cortisone or hyaluronic acid knee injections in the past 3 months
- •10. The patient has a body mass index greater than 35.
- •11. The patient has a history of substance abuse (e.g., recreational drugs, narcotics, or alcohol).
- •12. The patient was diagnosed with cancer within the last 2 years and received treatment with chemotherapy or received radiation therapy to the injured lower extremity.
- •13. The patient has a known allergy to the materials in the BioMatrix CRD.
- •14. The patient is currently involved in a study of an investigational product for a similar purpose.
- •15. The patient has a known co-morbidity that reduces life expectancy to less than 24 months.
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