Acceptability and Safety of 3D Printed Wrist-based Splints Compared to Plaster Casts for the Treatment of Non-surgical Distal Radius- and Scaphoid Fractures: a Randomized Feasibility Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change in "Patient Reported Splint Evaluation Questionnaire (PRSEQ)"
研究概览
简要总结
Non-invasiveness, avoidance of complications and comfort are important issues in the clinical management of conservatively treated distal radius and scaphoid fractures. To date, applying a plaster cast for approximately 6 weeks of immobilization is the gold standard. However, new 3D-technologies such as the design of Patient Specific Anatomical Braces (PSAB) will lead to a new paradigm of treatment. Swibrace has developed such anatomical, light, elegant and yet resistant braces. First, the fractured limb is scanned, the data then sent to a specifically designed software, printed in a 3D-printer and finally sent to the hospital for the patient's fitting. As these PSAB have not yet been tested on patients, the primary purpose of this study is to evaluate whether patient satisfaction with a 3D-printed PSAB differs from the one of traditionally treated patients in a plaster cast.
(A pre-clinical study will be conducted with 10 healthy volunteers testing the 3D splint for 72h. Only if splint satisfaction will be ≥ 70% as measured by the self-designed "Adult Rated Splint Evaluation Questionnaire" (ARSEQ), the 3D splint will be tested in patients. Otherwise, adjustments to the splint will be made based on the healthy volunteers' feedback prior to its testing in patients.)
详细描述
A criteria sample of 10 adult patients per group (Swibrace 3D splint and plaster cast) will be recruited in one University hospital in Switzerland and randomly assigned to either the 3D-splint or plaster cast group.
(For the pre-clinical study, the investigators aim to recruit 10 healthy volunteers testing one of the two 3D splint models (radius or scaphoid fracture splint).)
Study intervention:
Patients wear the Swibrace 3D splint for 6 weeks of immobilization of the wrist for distal radius fractures, including the basis of the thumb for scaphoid fractures. X-rays after week 1, 3 and 6 are planned to document bone healing, together with weekly visits at the hand therapy unit to measure patient satisfaction and hand function. This results in 2-3 surgeon and 6 hand therapy visits at the Inselspital Bern, where regular check-ups on the patient's comfort in the splint are made.
The control intervention is the same as the study intervention, but the participants wear the "gold-standard" plaster cast instead of the newly designed Swibrace 3D-splint. For the pre-clinical study, there is no control intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Masking is not feasible in this feasibility study, as the participants are not allowed to take off their splint (3D or plaster cast) during the bone healing time of 6 weeks. Care providers will take care of the patients prior to splint removal. Both the patients and the care providers are outcome assessors in this study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent as documented by signature
- •≥ 18 years old
- •Understanding of German language (written and oral)
- •Showing up at the Inselspital Bern emergency department with a stable, nondisplaced distal radius or scaphoid fracture that classifies a conservative immobilization treatment (as decided by the present surgeon on duty)
排除标准
- •Known or suspected non-compliance
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- •< 18 years old
- •Vulnerable persons
研究组 & 干预措施
3D-splint group
Patients wear the Swibrace 3D splint for 6 weeks of immobilization of the wrist for distal radius fractures, including the basis of the thumb for scaphoid fractures. X-rays after week 1, 3 and 6 are planned to document bone healing, together with weekly visits at the hand therapy unit to measure patient satisfaction and hand function. This results in 2-3 surgeon and 6 hand therapy visits at the Inselspital Bern, where regular check-ups on the patient's comfort in the splint are made.
干预措施: Swibrace 3D-splint (Device)
Plaster cast group
The control intervention is the same as the study intervention, but the participants wear the "gold-standard" plaster cast instead of the newly designed Swibrace 3D-splint.
干预措施: Plaster cast (Device)
结局指标
主要结局
Change in "Patient Reported Splint Evaluation Questionnaire (PRSEQ)"
时间窗: Part 1 will be filled out during (at week 2, 4, 6) and Part 2 after the splint wearing time (week 6).
The investigators designed this questionnaire to the best of their knowledge due to lack of pre-existing orthosis satisfaction questionnaires suitable for the study purposes. The PRSEQ will be completed by the participating patients. It consists of two parts: Part 1 consist of 5 main topics: (1) pain because of the splint, (2) personal experiences with the splint, (3) personal safety, (4) specific and (5) usual activities in the splint. Pictures from the splint are given to allow ticking pressure marks and skin irritations where they appeared. Part 2 consists of 3 main topics: (6) satisfaction with the splint, (7) personal attitude and (8) satisfaction with the scanning procedure. Each main topic includes several sub-questions, where the patient rates his/her answers on a 11-point-Likert scale (0-10).
次要结局
- Hand therapy evaluation - applying the "assessment of patient satisfaction"(Assessed during 6 hand therapy visits on a weekly basis until week 6, starting in week 1)
- Hand therapy evaluation - finger range of motion as assessed by a hand-held goniometer(Assessed during 6 hand therapy visits on a weekly basis until week 6, starting in week 1)
- Questionnaire "assessment of clinical effectiveness" as rated by specialized hand surgeons and orthopedists(Administered once at the end of the study after 6 weeks)
- Hand therapy evaluation - sensibility as measured by the "Ten Test"(Assessed during 6 hand therapy visits on a weekly basis until week 6, starting in week 1)
- Hand therapy evaluation - pain as measured by the "Numeric Rating Scale"(Assessed during 6 hand therapy visits on a weekly basis until week 6, starting in week 1)
- Bone position - x-ray evaluation by specialized hand surgeons and orthopedists(2-3 regular x-rays will take place during the bone healing phase after 1 week of splint wearing, if necessary in week 2 and after 6 weeks as assessed by physicians)
- Composite endpoint "adherence" assessed as the "number of clinical visits that were missed" / "number of drop-outs" and "number of patients crossing over to the plaster cast group"(Ongoing during the whole study period of 6 weeks)