Arthrofibrosis, Arthropathy of Knee, Knee Osteoarthritis
Conditions
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.
Interventions
DIAGNOSTIC_TESTTryptase, 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
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed