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Simple blood test may predict knee stiffness after replacement

NCT ID NCT03598829

Knowledge-focused Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study from the Mayo Clinic looked at 219 people getting total knee replacements to see if a blood test measuring an enzyme called tryptase could predict knee stiffness (arthrofibrosis) after surgery. Researchers measured tryptase levels before and after surgery and checked if higher levels were linked to more stiffness and pain. The goal is to find a simple way to identify patients at risk for this common complication.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a simple blood test to identify patients at higher risk for knee stiffness after replacement surgery, allowing for earlier treatment.
What could go wrong
This is an observational study, not a treatment trial. The blood test may not reliably predict stiffness, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

219 people

The number who actually took part.

Started

Jul 2018

Finished

Nov 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

20 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

osteoarthritis, knee

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arthrofibrosis Arthropathy of knee Knee osteoarthritis

Contacts and locations

Locations

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

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