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Knee scaffold implants show promise in small study

NCT ID NCT06475963

Knowledge-focused Sponsor: Istituto Ortopedico Rizzoli 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 followed 41 patients who received a scaffold implant for partial meniscal tears in the knee. Researchers collected data from telephone surveys and medical records to see how well patients were doing over time. The goal was to understand if this treatment helps with pain, function, and quality of life.

What this could mean

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

Active substance
scaffold implant
What this could lead to
If results are positive, this could support the use of scaffolds to repair meniscal tears and potentially delay knee osteoarthritis.
What could go wrong
This is a small, completed observational study with no control group, so it cannot prove the scaffold is better than other treatments. 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

41 people

The number who actually took part.

Started

Mar 2021

Finished

Jul 2025

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

Patients will be recruited from all subjects treated surgically with scaffolds (Actifit) for partial meniscal defects from January 01, 2009 to December 31, 2019

Ages

18 to 65 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: * Acute irreparable meniscal injuries requiring partial meniscectomy or chronic meniscal tissue loss (traumatic or degenerative) greater than 25%; Intact anterior and posterior meniscal horn respectively; * Peripheral meniscal rim (1 mm or more) along the entire circumference of the involved meniscus; * Knee stability or anterior cruciate ligament injury stabilized at the time of surgery; * Male or female patients between the ages of 18 and 65 years; * Healthy contralateral knee; * Normal axial alignment of the knee (mechanical tibio-femoral angle \< 3°) * Patients treated surgically with scaffolds (Actifit) for partial meniscal defects from January 01, 2009 to December 31, 2019 Exclusion Criteria: * Patients no longer available; * Concomitant posterior cruciate ligament (PCL) injury; * Advanced cartilage injuries according to Outerbridge classification (IV); * Incorrect axial alignment of the lower limb; * Documented allergy to polyurethane; * Local or systemic infection; * History of previous anaphylactoid reaction; * Systemic administration of corticosteroids or immunosuppressive drugs within 30 days prior to surgery; * Evidence of osteonecrosis in the involved knee; * Positive history of rheumatoid arthritis, inflammatory arthritis and autoimmune diseases; * Neurological disorders or conditions that may affect the rehabilitation protocol; * Pregnancy.

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Conditions

The condition(s) this trial relates to.

Knee Injuries osteoarthritis, knee

As listed by the trial registrant

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

Knee injuries Knee osteoarthritis Meniscus lesion

Contacts and locations

Locations

  • Istituto Ortopedico Rizzoli

    Bologna, 40136, Italy

More trials for these conditions

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