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



Status:Enrolling by invitation
Conditions:Arthritis, Osteoarthritis (OA), Orthopedic
Therapuetic Areas:Rheumatology, Orthopedics / Podiatry
Healthy:No
Age Range:20 - 100
Updated:7/27/2018
Start Date:July 1, 2018
End Date:July 1, 2021

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Trial Summary
Trial Overview
Inclusion Criteria
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.


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
We found this trial at
1
site
The Mayo Clinic
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
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