The Role of Cryopreserved Human Amniotic Membrane in the Surgical Repair of Peroneal Tendons: An Infrared Thermography Model
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months
研究概览
简要总结
Peroneal tendon tears are a common etiology encountered by foot and ankle surgeons. Like all flexor tendon repairs adhesions are one of the more common challenges after surgery. Peroneal tendon gliding is key to their function as effective plantar flexors and evertors of the hindfoot. Scarring and adhesion correlate directly with the amount of inflammatory reaction at the wound site (Adzick 1994). Our goal is to have a surgical technique that allows for standard suture repair of the tendon yet allows for smooth gliding of the tendon with minimal adhesions. A prospective review on the surgical repair of the peroneal tendons utilizing Clarix™1k (Amniox Medical, Marietta, GA), cryopreserved Human Amniotic Membrane (C-HAM) graft will be performed. The investigators hypothesize that the use of cryopreserved Human Amniotic Membrane in conjunction with a peroneal tendon repair will decrease that amount of inflammation, overall recovery time of surgically repaired peroneal tendon tears, and adhesions.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring surgical repair of the peroneal tendon
- •Patients who voluntarily consent to research participation
- •Patients over the age of 18
排除标准
- •Patients who display a high surgical risk as determined by the investigative surgeon
- •Previous surgical repair of the peroneal tendon less than 2 years prior to surgery
- •Peroneus brevis tears in zone 3 or 4 that may hinder recovery in the investigator's opinion
- •Patients with allergy or history of drug reactions to Ciprofloxacin or Amphotericin B
- •Patients who are pregnant or breast feeding.
- •Patients who have had a clinically diagnosed autoimmune disease
- •Patients who are unwilling to restrict pre and postoperative anti-inflammatories with the exception of ecotrin 325 mg QD for DVT prophylaxis during the postoperative immobilization period
- •Patients with an active infection
- •Patients who have a medical history that would likely make the patient an unreliable research participant
- •Patients requiring surgical repair of the peroneus longus tendon
研究组 & 干预措施
Clarix™1k graft
Group 1 will have standard peroneal repair surgery with the addition of the Clarix™1k tissue.
干预措施: Clarix™1k graft (Biological)
Control arm without Clarix™1k graft
Group 2 will have standard peroneal repair surgery without the use of the Clarix™1k tissue.
结局指标
主要结局
Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months
时间窗: Baseline,12 months
Ankle pain measured via visual analog scale (VAS), function measured by American Orthopaedic Foot and Ankle Society (AOFAS) ankle hindfoot scale and Foot Function Index (FFI), activity limitation measured by AOFAS scale. Images taken via thermal camera to measure inflammation were not interpretable. VAS pain scale: 0-100, with a lower number representing a better score FFI scale: 0-100, with a lower number representing a better score AOFAS scale: 0-100, with a higher number representing a better score
次要结局
未报告次要终点
研究者
Greg Berlet
MD
Orthopedic Foot and Ankle Center, Ohio