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临床试验/NCT05068297
NCT05068297Unknown不适用

The Impact of Germanium-Embedded Knee Brace on Patient Recovery After ACL Reconstruction: a Blinded and Randomized Controlled Trial

Total Sports Medicine & Orthopedics0 个研究点目标入组 100 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
Short Form 36 (SF-36)

研究概览

简要总结

Anti-inflammatory brace technology has demonstrated superior clinical outcomes in the management of knee osteoarthritis and accelerate recovery time for Major League Soccer players. Authors have postulated that embedding germanium into cotton garments increases circulation and augments the inflammatory process through a transdermal micro-electromagnetic field. In addition to immunomodulatory effects, knee braces immobilize and stabilize the joint through tactile feedback from the skin. Thus, a germanium-embedded knee brace may provide inflammatory control to augment pain and edema while concomitantly enhancing proprioception. ACL Reconstruction rehabilitation goals during the acute post-operative phase include diminishment of pain and edema as well as restoration of knee range-of-motion. The presented study intends to assess the impact of a germanium-embedded knee brace on patient recovery after ACL reconstruction.

Single-center blinded randomized controlled clinical trial to study effectiveness of germanium-infused knee brace on rehabilitation in patient population undergoing ACL reconstruction. Patients will be randomized into germanium-infused knee brace group and compared to a replica knee brace group. Inclusion criteria will include skeletally mature individuals undergoing primary ACL reconstruction. Exclusion criteria will include autoimmune disorders and history of surgery on ipsilateral joint. The presented protocol intends to assess the impact of a germanium-embedded knee brace on patient recovery after ACL reconstruction. The primary outcome measure was chosen for its implications for the design and conduct of the study,1 including well-validated outcome instrument for comparison, facilitation of a priori power analysis, randomization, and blinding. Secondary outcomes were chosen for their pertinence to surgeon decision-making during patient rehabilitation.

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)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-100 years old
  • Male or female
  • Compliant patient
  • BMI less than 35
  • Undergoing ACL reconstruction within 30 days

排除标准

  • Rheumatoid Arthritis
  • Poorly controlled diabetes (HgA1c > 7.5)
  • Previous blood clots
  • BMI greater than 35
  • Varicosities on operative leg

结局指标

主要结局

Short Form 36 (SF-36)

时间窗: 4 weeks

A well-validated patient reported outcome and the most commonly used outcome instrument in orthopaedics.

次要结局

  • Knee Range of Motion(6 weeks)
  • Pain Estimation(6 weeks)
  • Leg Circumference(6 weeks)

研究者

发起方
Total Sports Medicine & Orthopedics
申办方类型
Other
责任方
Sponsor

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