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Knee replacement study tests new alignment method, but stalls after just one patient

NCT ID NCT06617338

Knowledge-focused Sponsor: University of Louisville Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study aimed to see if using a patient's healthy knee as a guide for aligning a new knee joint during replacement surgery leads to better results than the standard method. Researchers planned to compare two groups of people with arthritis in one knee, using CT scans to plan the surgery. However, the study was stopped early after only one person enrolled, so no meaningful conclusions can be drawn.

What this could mean

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

Active substance
CT scan
What this could lead to
If successful, this approach could help surgeons better align knee replacements, potentially improving function and satisfaction.
What could go wrong
The study was terminated early with only 1 participant, so no reliable conclusions can be drawn. The approach may not work for everyone.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

1 person

The number who actually took part.

Started

Dec 2024

Finished

Mar 2026

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.

Ages

21 to 89 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: 1. Patient age is 21-89 at time of surgery 2. Patient is indicated to undergo a unilateral primary TKA, secondary to osteoarthritis 3. Patient's contralateral knee is non-arthritic 4. Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document 5. Patient is able to read and speak English. Exclusion Criteria: 1. Patient is under the age of 21 2. Patient's primary diagnosis is not osteoarthritis 3. Patient is unable to read and speak English 4. History of previous DVT/PE 5. History of stroke, CABG, or A fib 6. Current smoker

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Conditions

The condition(s) this trial relates to.

osteoarthritis osteoarthritis, knee

As listed by the trial registrant

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

Osteoarthritis (OA) of the knee

Contacts and locations

Locations

  • UofL Health

    Louisville, Kentucky, 40202, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.