Clinical Study to Evaluate Adaptos®Ortho Wedge Bone Graft Substitute in High Tibial Osteotomy: A Randomized, Controlled, Partially Blinded, Multi-Center Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Biomendex Oy
- 入组人数
- 87
- 试验地点
- 10
- 主要终点
- Radiographic bone regeneration of the osteotomy defect, comparison between three treatment arms.
研究概览
简要总结
The aim of this study is to obtain performance and safety data of the new investigational device, dual-part Adaptos®Ortho Wedge, for its intended use in orthopaedic surgery. The study intervention is medial open wedge high tibial osteotomy (OWHTO) with loadbearing plate fixation, where a bone graft substitute material Adaptos®Ortho Wedge is evaluated when used as a bone void filler. Investigational device is expected to support bone formation in osteotomy gap and to resorb in the body.
The comparator arms are treated with medial OWHTO with plate fixation, either without a bone graft (the bone defect is left empty, non-augmented osteotomy) or by using a comparator product (chronOS® Wedge, semi-circular) as a bone void filler.
详细描述
The study aims to evaluate the clinical performance and safety of Adaptos®Ortho Wedge (Biomendex Oy) bone graft material, when used for filling the medial osteotomy gap of the knee during OWHTO surgery.
This is partially randomized, subject and outcome assessor-blinded, controlled, multi-center study. The total study duration for each patient is planned to be 12 months. In total 6 visits per patient are scheduled in this study.
The study has three arms, and patients of all study arms are treated with medial OWHTO surgery to treat unicompartmental medial misalignment of the knee. Participants in the experimental arm (Arm 1) receive the investigational device, the osteotomy gap is filled with Adaptos®Ortho Wedge bone graft substitute. Participants in the control arm (Arm 2) receive the OWHTO treatment, where the osteotomy gap is left empty (no bone graft). Participants in the comparator device arm (Arm 3) receive the OWHTO treatment, where the osteotomy gap is filled with chronOS® Wedge bone graft substitute. In all three groups the metallic fixation plate (TomoFix®) is used for load bearing and for stabilizing the defect. The study device chronOS® Wedge (DePuy Synthes) and TomoFix® (DePuy Synthes) are CE-marked. The products are used within the indication.
The subject will be followed for twelve months following OWHTO.The radiological bone regeneration in the bony defect will be assessed at 6-weeks and 3-, 6-, and 12-months post-surgery.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged between 25 and 65 years at the time of enrolment.
- •Subjects that sign and date a written, informed consent form (ICF) prior to the initiations of any trial procedures, after the nature of the trial has been explained according to regulatory requirements.
- •Subjects who can comply with trial procedures and are available for the duration of the trial.
- •Accepts all treatment arms.
- •Subjects with varus malalignment of the knee, scheduled to have medial open-wedge high tibial osteotomy (OWHTO) but are otherwise in good health at the time of entry into the trial as determined by medical history, physical/clinical examination, and clinical judgement of the investigator.
- •Full knee range of motion (ROM) (at least 5-120 degrees).
- •Preoperatively planned osteotomy 5-13 degrees of the proximal tibia done based on the weight-bearing x-ray of the full leg in AP view using Miniaci Method.
- •Body Mass Index (BMI) ≤30
排除标准
- •Previous knee area osteotomy or lower limb arthroplasty of the investigational knee.
- •Presence of the following unfavourable conditions: osteoporosis, infectious/inflammatory joint disease, infections, or inflammation in the operation area, clinically relevant, not medically managed, severe acute or chronic medical illness, immune-compromised, metabolic/systemic bone disorder, untreated malignant myeloma, Burkitt's lymphoma, lateral osteoarthritis (Kellgren-Lawrence grade >1)
- •Smoking or use of other nicotine products
- •Inability to follow the procedures of the study, e.g. due to language problems, dementia, psychiatric disorder or behaviour etc. of the participant
- •Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment.
- •Women who are pregnant or breast feeding or planning to become pregnant during the study.
- •Any use of calcitonin, bisphosphonates or recombinant PTH 1-34, 1-84 or other PTH fragments/analogues 6 months prior to surgery or during the study (12 months po).
- •Enrolment of the investigator, his/her family members, employees, and other dependent persons.
- •Involved in study of another investigational product that may affect outcome.
结局指标
主要结局
Radiographic bone regeneration of the osteotomy defect, comparison between three treatment arms.
时间窗: Change from baseline to 12 months.
Radiographic bone regeneration assessments of the native x-ray of the standing anteroposterior (AP) radiographs of the knee, evaluated in the mediolaterally divided five zones of the osteotomized gap area (Brosset 2011), with rating of six bone remodeling phases (phases 0-5, with the score of 5 for the best outcome).The primary endpoint is the sum of the remodeling phase scores (0-5) in each of the five zones of the osteotomized gap area (range 0-25). Assessment longitudinally at 6-weeks and repeatedly at 3-, 6-, and 12-months post-surgery. Primary evaluation is done 12 months after surgery.
次要结局
未报告次要终点