A Prospective Clinical Trial Comparing Serum Mast Cell Tryptase (SMCT) Levels to Arthrofibrosis Rates Among Primary Total Knee Arthroplasty (TKA) Patients

Mayo Clinic219 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

219

Conditions

Knee Osteoarthritis Arthropathy of Knee Arthrofibrosis

Interventions

Tryptase, Serum testDIAGNOSTIC_TEST

Blood draw lab test which measures concentration of Tryptase in the sample. Tryptase is the one of the primary secretions of active mast cells and is used as a measure of inflammatory activity. Normal Reference Value: \<11.5 ng/mL

Eligibility

Sex: ALLMin age: 20 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Serum mast cell tryptase values

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.

Time frame: 1 year

Evaluate serum mast cell tryptase association with arthrofibrosis

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.

Time frame: 1 year

Secondary Outcomes

Evaluate the impact of allergic or inflammatory co-morbidities on serum mast cell tryptase levels

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.

Time frame: 1 year

Data from ClinicalTrials.gov

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