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

NCT ID: NCT03598829

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

219 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2023-11-15

Brief Summary

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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.

Detailed Description

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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

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Knee Osteoarthritis Arthropathy of Knee Arthrofibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Tryptase, Serum test

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Serum Tryptase Tryptase, S TRYPT Mast Cell Tryptase CPT Code 83520

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Matthew P. Abdel, M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthew Abdel, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

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18-004103

Identifier Type: -

Identifier Source: org_study_id