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

Mayo Clinic

Status: Completed

Conditions: Knee Osteoarthritis; Arthropathy of Knee; Arthrofibrosis

Treatments: Diagnostic Test: Tryptase, Serum test

Study type: Observational

Funder types: Other

Identifiers

NCT03598829

18-004103

Details and patient eligibility

About

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.

Full 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.

Enrollment: 219 patients

Sex: All

Ages: 20 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

219 participants in 1 patient group

Primary Total Knee Arthroplasty

Description:

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.

Treatment:

Diagnostic Test: Tryptase, Serum test