Proof of Concept: Clinical Validation Study of Personalized Orthopedic Splints With 3D Technology in Patients With Rhizarthrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Pain measured: Change of pain in patients with clasic orthrosis compared to the orthrosis designed using 3D technology
研究概览
简要总结
Osteoarthritis of the hand is a chronic joint disease that usually affects one or more of the finger joints and it is a major cause of disability. Radiology and the Eaton-Littler classification (Stages I-II-III-IV) are used for its diagnosis. The treatment of stages I, II and in some cases of stage III, is based on pharmacological and rehabilitation measures, including the use of orthoses or splints.
The development of Biosplint 3D will allow a qualitative leap forward in the search for an intelligent solution for patients with rhizarthrosis (Degenerative alteration of the trapezius-metacarpal joint (TMJ) characterized by a progressive deterioration of the articular surfaces and new bone formation in them).
The aim of the study is to assess the feasibility of applying a personalized splint versus a conventional one. It is not a design aimed at evaluating the efficacy of such treatment. It is a prospective study with two arms, open with 1:1 allocation.
The study includes a recruitment visit and two follow-up visits, one at a month and a final visit at 3 months. Patients with a new diagnosis of osteoarthritis of the trapeziometacarpal joint are included. One group of patients wears the usual splint indicated by the personalized doctors of the Service and the other group wears the 3D bi-splint.
The main variable is pain, which will be measured by a visual analog scale (VAS). In addition, the DASH questionnaire (Disabilities of the Arm, Shoulder and Hand) and questions about patient satisfaction with the use of splints will be used.
详细描述
Osteoarthritis of the TMJ is a disease present in a large part of the general population. The symptomatic prevalence is estimated at 6-8% of the population, although its radiological prevalence would be 29-76%. Its diagnosis is basically clinical, although radiological tests are very useful to confirm it and to typify the evolution of the disease.
The TMJ has a great range of mobility, since it basically serves to oppose the thumb to the rest of the fingers and to carry out grasping or pinching actions, which is why it is of great use and of great utility in everyday life. This range of movements is favored by being a not very congruent joint, but this fact also explains the tendency to instability, which can lead to abnormal movements between the joint surfaces, which ultimately lead to the development of osteoarthritis of the joint. joint. Over time, a subluxation occurs and the first metacarpal tends to approach the rest of the fingers, producing an adduction. This osteoarthritis leads to pain and functional disability. The pain is usually greater when the joint is stressed, during pincer movements.
• Conventional orthoses
Currently there are several types of splints on the market made of temperature-moldable plastic material, a splint that has multiple disadvantages in terms of manufacture:
- Polypropylene shrinks with heat, so it must be taken into account when designing. In addition, special care must be taken when heating and thermoforming it since the orthosis can collapse more easily. If it is not heated, it may not thermoform well.
- You cannot make rectifications, so you have to be careful with the mold and make screeds or modifications before adapting the polypropylene, since once it has been fused no changes can be made.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of osteoarthritis of the trapeziometacarpal joint.
- •Radiological stage of Eaton-Littler classification I / II.
- •Patients in whom the placement of a discharge splint is clinically indicated.
- •Score between 3 and 7 on the VAS pain scale (range 0 to 10).
排除标准
- •Previous treatment of osteoarthritis of the trapeziometacarpal joint.
- •Refuses to participate in the study.
- •Disabilities that prevent the completion of the questionnaires.
- •Presence of severe deformations in the hand.
- •Presence of other alterations, such as carpal tunnel syndrome, tendonitis or chronic inflammatory arthropathies.
结局指标
主要结局
Pain measured: Change of pain in patients with clasic orthrosis compared to the orthrosis designed using 3D technology
时间窗: Pain measurement by visual analog scale is performed at the baseline visit, at the second visit (one month later) and at the third follow-up visit (end of the study) which will take place at the third month of follow-up (between 11-14 weeks).
By visual analog scale from 0 (no pain) to 10 (unbereable pain)
次要结局
- 3D orthoses change functionality(Functionality is performed at the baseline visit, at the second visit (one month after) and at the third follow-up visit (end of the study), which will take place at the third month of follow-up (between 11-14 weeks).)
- Satisfaction and compliance are equally superior in the 3D orthosis.(Satisfaction is performed at the second visit (one month after) and at the third follow-up visit (end of the study), which will take place at the third month of follow-up (between 11-14 weeks).)