A Study to Assess Pre- and Postoperative Serum Mast Cell Tryptase Levels in Primary TKA Patients to Determine Whether There is an Association with the Development of Post-operative Stiffness
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-004103
NCT ID: NCT03598829
Sponsor Protocol Number: 18-004103
About this study
This study aims to assess pre- and postoperative serum mast cell tryptase levels in primary TKA patients to determine whether there is an association with the development of post-operative stiffness.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patients with osteoarthritis who are surgical candidates for primary TKA
- Male or female patients between the ages of 20 years to 100 years old
- Able to give 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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Matthew Abdel, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available