Clinical Outcome After Episealer Talus Implant in Treatment of Osteochondral Lesion of the Talus
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Implant survival
研究概览
简要总结
Autologous Chondrocyte Implantation (ACI) is an appealing technique whereby cartilage is harvested from the joint in a first operation. This biopsy is processed, individual cells are freed and cultivated and, in a second procedure, injected into the defect that has been covered by a periosteal graft). A second generation includes a matrix (MACI) into which the cells are injected/cultivated. Recently, collagen membranes are used to cover the cells or cover a micro-fractured defect. Good results have been reported although return to previous sports remains a challenge . Long term results are lacking. More important is the fact that these treatments are directed towards restoring the articular cartilage whereas the patient's symptoms are generated by the bone and not the cartilage.
Treatment of an OCD with a small metallic implant has been tested in recent years. Results have been promising by some reports, while a high revision rates was reported by others. A recent 2-8 years follow-up study revealed a survival rate of 95 %
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteochondral lesion (both primary and secondary lesions) ⌀ 10-15 mm on the medial or lateral talar dome
- •age between 18 and 65 years
- •BMI < 35
- •patients who have given their willingness to reach the Institute for checkups.
- •patients previously treated with conservative therapies, which proved unsuccessful
排除标准
- •non-focal defect
- •on-going infection in the ankle joint
- •inflammatory arthritis or radiographic osteoarthritis in the ankle joint (=no joint space narrowing) Osteophytes without joint space narrowing (=Gr1 (van Dijk classification)) is not a contra indication.
- •sensitivity to cobalt-chrome alloys and titanium materials
- •inadequate bone stock where the Episealer is to be inserted
- •existing prosthesis in the area of treatment or opposing surface
- •osteochondral lesion on opposing tibial surface
- •pain of unknown etiology
- •demineralised bone
- •instability. Instability is defined as recurrent giving way with or without laxity
- •severe malalignment in the ankle joint >5 degrees malalignment as compared to the contralateral ankle joint, as measured on the standing X-Ray
- •Ipsilateral symptomatic foot, knee or hip disease which affects the mobility of the patient
- •other diseases or medication that may affect the bone anchoring of the Episealer
- •uncooperative patient that is not willing to follow instructions
- •muscular insufficiency
- •vascular insufficiency
- •medical, hormonal, hematological, immunological or metabolic illnesses
- •Pregnancy
研究组 & 干预措施
Sperimental
Implantation of Episealer Talus Implant
干预措施: Implantation of Episealer Talus Implant (Procedure)
结局指标
主要结局
Implant survival
时间窗: after 5 years
Implant survival rate at 60 months follow-up
FOOT AND ANKLE OUTCOME SCORE - pain
时间窗: after 12 months from the intervention
The FAOS (Foot and Ankle outcome score) is a 42-item questionnaire, 9 for pain
FOOT AND ANKLE OUTCOME SCORE -symptoms
时间窗: after 24 months from the intervention
The FAOS (Foot and Ankle outcome score) is a 42-item questionnaire, 7 items for symptoms
FOOT AND ANKLE OUTCOME SCORE - Pain
时间窗: after 24 months from the intervention
The FAOS (Foot and Ankle outcome score) is a 42-item questionnaire, 9 for pain
次要结局
未报告次要终点
研究者
Stefano Zaffagnini
Principal Investigator
Istituto Ortopedico Rizzoli