A Prospective Clinical Trial Comparing Serum Mast Cell Tryptase (SMCT) Levels to Arthrofibrosis Rates Among Primary Total Knee Arthroplasty (TKA) Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 219
- 试验地点
- 1
- 主要终点
- Serum mast cell tryptase values
研究概览
简要总结
This research is being done to see if the amount of an enzyme in blood (called serum mast cell tryptase) changes before and after surgery. The investigators would like to see if these amounts are related to knee stiffness and pain in subjects that undergo a total knee replacement.
详细描述
Arthrofibrosis (AF), characterized by pain and limited mobility, affects a notable percentage of patients post-total knee arthroplasty (TKA). Despite various treatment advancements, the condition remains challenging to manage. Prior research has indicated a relationship between elevated serum mast cell tryptase (SMCT) levels and increased fibrosis in animal models, suggesting that SMCT could serve as a biomarker for arthrofibrosis in humans. This study aims to 1) assess pre- and postoperative SMCT levels in TKA patients, 2) evaluate SMCT's association with arthrofibrosis and clinical outcomes, and 3) determine the impact of allergic or inflammatory co-morbidities on SMCT levels.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Investigators will include all patients with osteoarthritis who are surgical candidates for primary TKA. Investigators will include all eligible male or female patients between the ages of 20 years to 100 years old. All included study participants must be able to give an informed consent.
排除标准
- •Significant femoral or tibial deformity due to congenital or traumatic etiologies, inflammatory arthritis, post-septic arthritis, osteomyelitis, prior infection of knee joint, osteoporosis, dislocated or fragmented patella
- •Patients taking mast cell inhibitors and/or degranulation inhibitors for any reason.
- •The presence of infections, highly communicable diseases (e.g. AIDS), active tuberculosis, venereal disease, hepatitis.
- •Significant neurological or musculoskeletal disorders or disease that may adversely affect normal gait or weight bearing.
- •Presence of previous prosthetic knee replacement devices (of any type)
- •Metastatic disease
- •Psychiatric illness
- •Drug or alcohol abuse
- •Inability to participate in standard postoperative rehabilitation protocol
结局指标
主要结局
Serum mast cell tryptase values
时间窗: 1 year
Serum mast tryptase values will be assessed pre and postoperatively to evaluate changes that can be expected in patients who are undergoing total knee replacement.
Evaluate serum mast cell tryptase association with arthrofibrosis
时间窗: 1 year
For patients who developed arthrofibrosis after total knee replacement, we will examine if a significant change in serum mast cell tryptase accompanies this outcome. This will help evaluate if tryptase levels may be useful as a marker of risk for arthrofibrosis.
次要结局
- Evaluate the impact of allergic or inflammatory co-morbidities on serum mast cell tryptase levels(1 year)
研究者
Matthew P. Abdel, M.D.
Principal Investigator
Mayo Clinic