Clinical Outcomes Related to Hallux Valgus Correction Surgery Recovery Using Semiconductor Embedded Therapeutic Sleeves: A Randomized, Double-Blind, Placebo-Controlled Clinical Investigation
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Change in participant Foot and Ankle Outcome Score (FAOS)
研究概览
简要总结
This study is looking to test a non-compressive semiconductor embedded ankle sleeve and sock for post hallux valgus correction surgery rehabilitation. Hallux valgus (HV), commonly known as a bunion, is one of the most prevalent forefoot deformities. It affects approximately 23% of adults aged 18 to 65 and 36% of those over 65. Given the high incidence of HV, various surgical correction methods have been developed, with first tarsometatarsal (TMT) arthrodesis (Lapiplasty Arthrodesis) and first metatarsophalangeal (MTP) arthrodesis demonstrating the highest success rates in restoring function and preventing recurrence. Post-surgical symptoms typically include pain, swelling, and tenderness, but with proper rehabilitation and preventive measures, patients generally return to activity within weeks to months.The semiconductor embedded fabric increases blood circulation through activation of the embedded elements with body heat while worn and releases far infrared waves as well as negative ions. This energy has an effect inside the body that increases oxygen and nutrient flow to tissues, and can help to decrease pain and inflammation. This study is testing this technology to see if it can be used as a non-pharmacological treatment for rehabilitation post hallux valgus correction 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, Investigator)
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
- 否
入选标准
- •Patients undergoing hallux valgus correction surgery including Lapiplasty Arthrodesis, MTP fusion, and TMT+MTP arthrodesis (double first ray arthrodesis).
- •Patients aged 18-75
- •Patients who are willing and able to adhere to follow-up schedule and protocol guidelines.
- •Patients who are willing and able to sign corresponding research subject consent form.
排除标准
- •Patient has a history of neurological conditions, including multiple sclerosis or Parkinson's disease
- •Patient has severe medical condition, including recent myocardial infarction, unstable angina, heart failure, severe anemia
- •Patient has had prior surgical treatment of the foot within the last 5 years
- •Patient has external hardware (wires) protruding from the foot post-surgery
- •Patient has had prior injections (PRP or Stem Cell) in the foot within the last 1 year
- •Patient has rheumatoid arthritis
- •Patient has chronic pain conditions unrelated to foot condition
- •Patient has auto-immune or auto-inflammatory diseases
- •Patient has used tobacco within the last 90 days
- •Patient has poorly controlled diabetes as determined by A1C levels > 7.0
- •Patient has an active infection (local or systemic)
- •Patient is unwilling or unable to sign the corresponding research subject consent form
- •Patient meets any other criteria or has any other condition that, in the opinion of the investigator, would prevent them from completing the study or that, in the opinion of the investigator, would confound study results.
研究组 & 干预措施
Placebo Device
Identical device absent of semiconductors
干预措施: Placebo ankle sleeve and sock (Device)
Active Device
Semiconductor Embedded Ankle Sleeve and Sock
干预措施: Semiconductor embedded ankle sleeve and sock (Device)
结局指标
主要结局
Change in participant Foot and Ankle Outcome Score (FAOS)
时间窗: 3 months
Changes in participant function and pain as determined by the Foot and Ankle Outcome score (FAOS) FAOS: Lowest score: 0 (extreme symptoms/limiations) Highest score: 100 (no symptoms or limitations)
次要结局
- Change in participant Foot Function Index (FFI)(3 months)
- Changes in participant American Orthopedic Foot and Ankle Society-Hallux Valgus Score (AOFAS)(3 months)
- Participant-reported changes in pain(3 months)
- Changes in oral medication intake compared to placebo group(3 months)
- Changes in swelling of the foot compared to placebo group(3 months)
- Changes in participant soft tissue thickness compared to placebo group(3 months)