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NCT03598829 Clinical Trial

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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03598829
Other study ID # 18-004103
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 1, 2018
Est. completion date July 2024

Study information
Verified date August 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 222
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 100 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary SMCT values Serum mast tryptase values will be assessed post-operatively 1 year
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