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

NCT03598829 | Completed

• 1 other identifier: 18-004103
• Study Type: observational
• Target: 219
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthrofibrosis; Knee Osteoarthritis; Arthropathy of Knee

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

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

  1 year

Study Arms (1)

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.

Diagnostic Test: Tryptase, Serum test

Interventions

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

Also known as: Serum Tryptase, Tryptase, S, TRYPT, Mast Cell Tryptase, CPT Code 83520

Primary Total Knee Arthroplasty

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Males or females between the ages of 20 to 100 years who are surgical candidates for primary total knee replacement.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Matthew Abdel, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: July 26, 2018
• Study Start: July 1, 2018
• Primary Completion: November 15, 2023
• Study Completion: November 15, 2023
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)