Clinical and Radiological Comparison of Hallux Valgus Correction Using the Metal Screw or the Human Allogeneic Cortical Bone Screw, a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- clinical result of Hallux Valgus treatment
研究概览
简要总结
The goal of this clinical trial is to compare the treatment of Hallux Valgus using the conventional method (metal screw) with the new method (human allogeneic cortical bone screw (Shark Screw®) in adult patients with confirmed Hallux Valgus.
The main questions it aims to answer are:
Can the new method obtain comparable results as the conventional method in regard to union rate and time to union? Are the number of complications lower with the new method? Participants will be operated either with the metal screw or with the Shark Screw®. The assignment to the groups is randomized.
详细描述
The planned prospective study will investigate whether the use of the human allogenic cortical bone screw (Shark Screw® leads to comparable results in the union rate and the prevention of recurrences as with metal screws. Furthermore, it will be investigated whether rotational stability is possible with the bone screw. The measurement of the HVA angle and the IMA angle should provide information on whether the correction is stable over time. A comparison of the AOFAS forefoot score before and after the operation for both methods is a further measure to check whether the human allogenic cortical bone screw can deliver similar results.
Initial studies on the use of the allogenic bone screw in hand and foot surgery show particularly good integration behavior of the human allogenic cortical bone screw . A retrospective study by Hanslik-Schnabel et al has shown initial positive results in the treatment of hallux rigidus. In addition, a gait analysis is performed pre- and postoperatively to provide information on possible differences between the two groups in the context of 3D gait analysis/pedobarography and is also matched with another healthy cohort.
At the preoperative time point and after 12 and 24 months, a 3D gait analysis with a foot model is conducted to record the joint kinematics and kinetics. In the study by Canseco et al. , the proximal gait pattern changes remained unchanged. Hwang reported hyper-external rotation in the subtalar joint, excessive eversion in the subtalar joint, and lack of movement in the hallux MP joint in the terminal standing phase.
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)
盲法说明
does get the information only after 2 years at the end of teh study
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between 18 and 85
- •confirmed Hallux Valgus
排除标准
- •<18 years and >85 years
- •Known underlying oncological disease
- •Pregnant women or breastfeeding mothers
- •Alcohol and drug abuse
- •Foreseeable compliance problems
- •Foreseeable loss of responsibility as a study doctor
- •Neoplastic diseases
- •Active osteomyelitis
- •Ulcerations in the area of the skin of the surgical site
- •Immunosuppressive medication that cannot be discontinued
结局指标
主要结局
clinical result of Hallux Valgus treatment
时间窗: 2 years
The primary objective of the study is the longitudinal evaluation of clinical outcomes (pain, appearance) over 2 years after hallux correction using a human, allogenic, bone screw or metal screw.
次要结局
- Intermetatarsal angle (IMA) change(2 years)
- change in forefoot-American Orthopaedic Foot and Ankle Society (AOFAS)(2 years)
- Hallux-Valgus angle (HVA) change(2 years)
- radiological (bony union)result of Hallux Valgus treatment(1 years)
- gait analysis(2 years)
研究者
Forian Wenzel-Schwarz
principal investigator
Orthopedic Hospital Vienna Speising
