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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Total Knee Arthroplasty | All patients enrolled in this study were part of the same recruitment group who whose SMCT levels will be observed pre and postoperatively. Primary TKA patients are having their native knee replaced. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tryptase, Serum test | Diagnostic 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Males or females between the ages of 20 to 100 years who are surgical candidates for primary total knee replacement.
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Abdel, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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IPD will not be shared, as Mayo Clinic is the only institution involved in this research study and results reporting will be done via summary metrics and statistical analysis. Research participants did not consent for IPD to be shared outside of Mayo Clinic.
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|
| 1 year |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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