Does Wrapping With Bone Marrow Injection Enhance Healing of Meniscal Sutures Into the Non-vascular Area: A Prospective Randomised Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Failure rate
研究概览
简要总结
This study will compare meniscal healing of non-vascularised area augmented or not by bone marrow injected under a protective collagen membrane (meniscal wrapping)
详细描述
Historically, meniscus was considered as none essential for knee joint, and its removal by meniscectomy was the first-line treatment. Many studies have shown a negative progress towards osteoarthritis after meniscus ablation. This approach has gradually changed to preserve this meniscal capital, making way for new treatments as sutures. However the vascular organization of the meniscus is crucial for its cure. The healing potential of lesions in the meniscus non-vascularised aera is considered insufficient, and are often treated by a partial meniscectomy, resulting in a high risk of osteoarthritis. It appears therefore necessary to develop new strategies, as meniscal wrapping, to preserve meniscus presenting this type of damage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic or traumatic tears of medial or lateral meniscus;
- •Tearing affecting: only 2/3 central (= avascular zone) over more than 1 cm OR extending from the peripheral third (= vascularized area) within the avascular zone over more than 1 cm. In this case, preservation of the peripheral third over a width of at least 4 mm from the capsule;
- •Single or multiple tears.
排除标准
- •Meniscal tears that can not be sutured, reduced / approximated
- •Tear creating a meniscal root avulsion
- •Partial meniscal tears
- •Meniscal tears already sutured
- •Cartilage damage in the compartment> grade 2 (ICRS classification)
- •Mechanical axis (varus / valgus) ≥ 2 °
- •Untreated ligament deficiency
- •Osteotomy and / or concomitant ligament reconstruction, with the exception of ACL reconstruction.
- •Compromised general health condition (score ASA score> 2)
- •Active smoking, drug use
- •Allergy to porcine collagen
- •Poor compliance
研究组 & 干预措施
Suturing meniscal augmented
Non-vascularised area meniscus tear was sutured and bone marrow was injected under a protective collagen membrane (ChondroGide)
干预措施: suturing meniscal augmented (Procedure)
Suturing meniscal
Non-vascularised area meniscus tear was only sutured
干预措施: suturing meniscal (Procedure)
结局指标
主要结局
Failure rate
时间窗: up to 24 months
Number of readmission for meniscus tear
Change in integrity and healing of meniscus repair
时间窗: 12 and 24 months after treatment
Arthrography (arthro-CT)
International Knee Documentation Committee Score (IKDC)
时间窗: baseline and 3, 12 and 24 months after treatment
Change in physical pain and function as assessed by IKDC score from baseline to 24 months post-surgery
SF-12 Survey
时间窗: baseline and 3, 12 and 24 months after treatment
Change in functional health and well-being as assessed by SF-12 Survey from baseline to 24 months post-surgery
Knee injury and Osteoarthritis Outcome Score (KOOS)
时间窗: baseline and 3, 12 and 24 months after treatment
Changes in the 5 subscales of KOOS as assessed from baseline to 24 months post-surgery
次要结局
- Change in integrity of meniscus and adjacent tissues (cartilage, bone, synovial tissue)(12 months after treatment)
- Rate of suture type-associated complications(up to 24 months)
研究者
Dr. Robin Martin
Principal Investigator
Centre Hospitalier Universitaire Vaudois