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Could donor tissue replace metal knee implants?

NCT ID NCT07769632

Cure Sponsor: AlSalam Hospital 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Last updated Aug 20, 2026 · Updated 2 times

Summary

This trial is testing a new type of knee replacement for younger patients with severe knee osteoarthritis. Instead of the standard metal and plastic implant, surgeons will use a graft made of donor bone, cartilage, and meniscus to replace the damaged parts of the knee. The goal is to see if this biological approach can provide better range of motion, allowing patients to sit on the floor and maintain an active lifestyle. The study will measure how well the graft fuses with the patient's own bone and assess pain, stiffness, and physical function using the WOMAC score.

What this could mean

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

Active substance
allogenic bone and cartilage graft
What this could lead to
If successful, this could offer a more natural knee replacement option that preserves greater range of motion, potentially allowing patients to sit on the floor and maintain an active lifestyle.
What could go wrong
This is a very early, small trial (10 participants). The graft may fail to fuse with the native bone, and there are risks of infection, rejection, or the procedure not providing lasting benefit.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 10 people

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

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Oct 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

45 to 70 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: * Being between 45 and 70 years of age of either gender. (OAK is common in this Age group) * Diagnosed with OAK with Kellgren and Lawrence Grading III and IV. * No ligamentous laxity and varus or valgus deformity. (In standard TKR patients with ligamentous laxity Constrained Condylar Knee (CCK) with intramedullary stem is used). * Patients who wish to have an active lifestyle. * Agreeing to participate and signing informed consent voluntarily. Exclusion Criteria: * Previous knee surgery within six months. * Uncontrolled Diabetes Mellitus * Chronic Kidney Disease. (Patients on hemodialysis) * Metabolic bone disease. (Severe osteoporosis with T Score of -\<3.5) * Patients who will not consent to follow-up. * Mental disorders and drug dependency (Patients who cannot understand the consent or the procedure of the TOCR).

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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

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

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • AlSalam Specialist Hospital

    Manama, 80278, Bahrain

More trials for these conditions

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