A Prospective Randomized Trial Comparing Tendon Wrapping With Amniotic Membrane and Tenolysis Versus Tenolysis Alone for Treatment of Tendon Adhesions of the Hand and Wrist
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Passive Range of Motion (PROM)
研究概览
简要总结
Tendon adhesions of the hand remain a ubiquitous problem facing hand surgeons and hand therapists alike. Despite their commonality, no consensus exists as to the best means of preventing adhesions, or the most ideal methods to treat them once they have occurred. The purpose of this study is to compare patient outcomes after standard operative tenolysis performed for adhesions of the hand to outcomes after tenolysis with the use of allograft human amniotic membrane.
详细描述
Patients who are scheduled to undergo operative tenolysis of the flexor and/or extensor tendons of the hand will be recruited. Our target enrollment is 40 patients (20 control plus 20 experimental), based on the power analysis detailed in the next paragraph. Enrolled patients will be randomized to either standard operative tenolysis, or tenolysis with placement of AlloWrap. Randomization will be performed by computerized random number generator. All surgeries will be performed by one senior fellowship-trained hand surgeon. Baseline measurements of total active motion (TAM), passive range of motion (PROM), and survey scores of the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) and Patient Rated Wrist Evaluation (PRWE) will be recorded pre-operatively. In addition, patients' pain level will be assessed using the visual analog scale (VAS) both at rest, and during the examination. These same values will be re-evaluated at post-operative follow-up visits at 2 weeks, 1 month, 3 months and 6 months. PROM will also be evaluated intra-operatively by the surgeon, and documented.
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, 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
- •All adult patients deemed candidates for operative tenolysis of the hand or wrist
排除标准
- •Patients younger than 18 years at the time of surgery;
- •Any patient who would not be able or willing to comply with the protocol or perform assessments;
- •Patients with medical conditions that may preclude placement of human biological membrane;
- •Patients who have previously undergone tenolysis on the operative hand;
- •Patients that will have multiple surgeries that are deemed as possible confounders, particularly those requiring an additional incision;
- •Is physically or mentally compromised (i.e. being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease) in a manner that would compromise his or her ability to participate in the clinical study;
- •Is a prisoner;
- •Is a transient.
结局指标
主要结局
Passive Range of Motion (PROM)
时间窗: 6 months
Total Active Motion (TAM)
时间窗: 6 months
次要结局
- Patient-Rated Wrist Evaluation (PRWE)(6 months)
- Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)(6 months)
- Complications(2 weeks, One month, 3 months, 6 months)