NCT03598829

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 219 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 20 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Knee Osteoarthritis
• Arthropathy of Knee
• Arthrofibrosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Tryptase, Serum 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

Timeline

• Start date: 2018-07-01
• Primary completion: 2023-11-15
• Completion: 2023-11-15
• First posted: 2018-07-26
• Last updated: 2025-12-18

Locations

1 site across 1 country: United States