A Prospective Randomized Clinical Trial Using Dehydrated Human Amnion/Chorion Membrane (dHACM) in Total Knee Replacement Patients to Reduce Post-operative Scarring.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Increased range of motion between both groups as measured by goniometer
研究概览
简要总结
The overall objective of this study is to evaluate the effectiveness of dHACM in reducing scar tissue formation in total knee replacement patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are adults ages 18 or older.
- •Are diagnosed with advanced osteoarthritis as determined by clinical exam and necessitate total knee replacement.
- •Have a willingness to comply with follow-up examination.
- •Have ability to give full written consent.
排除标准
- •Has had a previous total or partial joint replacement performed at the same site
- •Has a planned bilateral procedure at this time. Bilateral patients can be enrolled if the procedures are staged.
- •Has signs or symptoms of any other disease which could result in allograft failure, or has experienced allograft failure in the past.
- •Has used any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.
- •Is pregnant or may become pregnant during the study.
- •Is a prisoner.
- •Has any condition(s) which seriously compromises the subject's ability to participate in this study, or has a known history of poor adherence with medical treatment.
- •Is currently taking medications which could affect allograft incorporation (supervising physician's discretion).
- •Is confined to bed or a wheelchair.
- •Has clinical signs and symptoms of local infection at the site.
- •Has autoimmune disease or a known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
- •Has current diagnosis of cancer at the site.
- •Has had prior radiation therapy treatment at the site.
- •Is currently taking anticoagulant therapy.
- •Is unable to sign or understand informed consent.
- •Has a history of drug or alcohol abuse within last 12 months.
- •Is allergic to Aminoglycoside antibiotics (such as gentamicin and/or streptomycin).
研究组 & 干预措施
dHACM
Total knee arthroplasty, per the usual practice of the physician with application of dHACM between the underlying fascia and the overlying skin layers to reduce scar formation
干预措施: Total Knee Arthroplasty (Procedure)
dHACM
Total knee arthroplasty, per the usual practice of the physician with application of dHACM between the underlying fascia and the overlying skin layers to reduce scar formation
干预措施: Application of dHACM (Other)
Control
Total knee arthroplasty, per the usual practice of the physician without application of dHACM.
干预措施: Total Knee Arthroplasty (Procedure)
结局指标
主要结局
Increased range of motion between both groups as measured by goniometer
时间窗: 6 weeks
次要结局
- Incidence of need for manual manipulation of affected knee(6 weeks)