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New dissolvable nail aims to fix knee fractures without metal hardware

NCT ID NCT06423378

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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 tests a special nail made from a material that integrates with bone to treat knee fractures caused by bone weakness (subchondral insufficiency). Ten adults aged 18-75 with knee pain for at least 3 months will receive the implant. Researchers will measure pain and function improvements over time.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

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

18 to 75 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: * Agree to study participation and consent obtained. * Able to attend all postoperative clinical visits, undergo imaging procedures, and complete relevant questionnaires. * Subjects between the ages of 18 to 75 years. * Body Mass Index \< 40. * Has knee pain in the study knee lasting at least 3 months and has had at least moderate pain recorded on a standard of care (SOC) preoperative Knee Injury and Osteoarthritis Outcome Score (KOOS) and/or Numeric Pain Reported Scale (0-10) questionnaire. The study team may utilize these verbal pain scores collected during the clinic intake process for screening purposes. If the patient was not administered the verbal pain score, the patient will be consented, administered the pain survey, and withdrawn if moderate pain score was not recorded. * At least 3-months without steroid injection or any other non-surgical intervention administered to study knee. * Candidate for knee arthroscopy due to meniscal tear, loose body, unstable articular cartilage or mechanical symptoms. * Uni-compartmental Kellgren-Lawrence grade 2-3 osteoarthritis in the study tibia or femur. * Bone Marrow Lesion (BML) confirmed on magnetic resonance imaging in the femur, tibia or both. * Cartilage lesion on the tibial or femoral condyle(s) of a grading ≤4 by either the International Cartilage Repair Society or Outerbridge classifications verified at the time of arthroscopy. Exclusion Criteria: * Imaging evidence of the study knee that includes any of the following: 1. Kellgren-Lawrence grade 4 osteoarthritis. 2. Collapse of subchondral bone. 3. Avascular Necrosis (AVN). 4. Osteochondral defect overlying the BML 5. BML located at ACL or PCL insertions * Clinical evidence of the study knee that includes any of the following: 1. History of rheumatoid arthritis, septic arthritis, reactive arthritis, gout or pseudogout, secondary arthropathy (e.g., hemochromatosis, hemophilia, or psoriasis). 2. Osteochondritis dissecans. 3. Frank ligamentous instability. 4. Neuromuscular deficiency or other that would limit the ability to do a functional assessment. * Bi-cortical nail implantation cannot be achieved, including where the required nail length is not yet available. * Current tobacco use or has quit within 3 months of study enrolment. * Substance abuse history. * Diabetes mellitus, HbA1c\>8 * High surgical risk due to pre-existing conditions. * Currently pregnant or has plans to become pregnant prior to surgery. * Active infection or history of chronic infection in study knee. * Will require concomitant procedures within study knee, including but not limited to ligament reconstruction, tendon repair, meniscus repair, microfracture, osteotomy, or osteochondral transplantation (Meniscal tears, including chronic, are acceptable if no repair is required) * Significant malalignment (varus or valgus) of the knee (\>8°) * Use of augmentation or concomitant biologic therapy during surgery. * Contraindications to magnetic resonance imaging. * Any condition which in the view of the treating physician makes it inadvisable for the subject to participate in the study.

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As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

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