A Prospective Clinical Trial Comparing Serum Mast Cell Tryptase (SMCT) Levels to Arthrofibrosis Rates Among Primary Total Knee Arthroplasty (TKA) Patients
- Conditions
- Knee OsteoarthritisArthrofibrosisArthropathy of Knee
- Registration Number
- NCT03598829
- Lead Sponsor
- Mayo Clinic
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 219
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum mast cell tryptase values 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 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.
- Secondary Outcome Measures
Name Time Method Evaluate the impact of allergic or inflammatory co-morbidities on serum mast cell tryptase levels 1 year We will aim to examine to what extent allergic or inflammatory conditions influence changes in serum mast cell tryptase levels for patients undergoing total knee replacement. This aids in determining if underlying patient health affects how useful tryptase measurements could be as a marker for risk of arthrofibrosis, or if there is an association between these conditions and increased risk for arthrofibrosis.
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States