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One-Shot collagen jab could soothe aching knees

NCT ID NCT04998188

Symptom relief 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 study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 whether a single injection of collagen into the knee joint can reduce pain and improve function in people with knee osteoarthritis. Researchers will compare the collagen injection to a placebo (saline) injection in 204 adults. The main goal is to see if collagen provides better pain relief over 6 months.

What this could mean

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

Active substance
collagen injection
What this could lead to
If it works, this could provide a simple, one-time injection to reduce knee pain from osteoarthritis.
What could go wrong
This is an early-stage trial comparing collagen to a placebo (saline). The effect may be small or no better than placebo, and results are limited to 6 months.

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

About 204 people

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

Started

Feb 2022

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: 1. Unilateral involvement; 2. Signs and symptoms of degenerative pathology of knee cartilage; 3. Radiographic and MRI signs of degenerative pathology of the knee cartilage (Kellgren-Lawrence 1-4 grades); 4. Failure, defined as the persistence of symptoms, after at least one course of conservative treatment (pharmacological, physiotherapeutic or infiltrative treatment); 5. Ability and consent of patients to actively participate in clinical follow-up; Exclusion Criteria: 1. Patients who have undergone intra-articular injections of another substance in the previous 6 months; 2. Patients undergoing knee surgery within the previous 12 months; 3. Patients with malignant neoplasms; 4. Patients with rheumatic diseases; 5. Patients with diabetes; 6. Patients with hematologic diseases (coagulopathies); 7. Patients on anticoagulant therapy; 8. Patients with metabolic disorders of the thyroid gland; 9. Patients abusing alcoholic beverages, drugs or medications; 10. Body Mass Index \> 35; 11. Pregnant or lactating women. 12. Patients with established hypersensitivity to bovine collagen or vitamin C. 13. Patients with joint or peri-articular infections, emarto, erythema, or psoriatic patches in the knee joint area

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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.

Knee osteoarthritis

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

  • Istituto Ortopedico Rizzoli

    RECRUITING

    Bologna, 40136, Italy

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