Cheaper collagen injection could rival standard knee OA treatment

NCT ID NCT07692009

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This trial tests whether a collagen-based injection (Fibroquel) works as well as a standard hyaluronic acid injection (Synvisc) for knee osteoarthritis. About 32 adults with moderate knee OA will receive three weekly injections of one treatment. The study measures knee function and pain over six months to see if the less expensive collagen option is a good alternative.

What this could mean

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

Active substance
collagen-polyvinylpyrrolidone (collagen-PVP, Fibroquel)
What this could lead to
If collagen-PVP works as well as Synvisc but costs less, it could offer a more affordable option for managing knee osteoarthritis pain and function.
What could go wrong
This is a small, early-phase study with only 32 participants, so results may not apply broadly. Both treatments are injectable and carry risks like joint pain or infection.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

32 people

The number who actually took part.

Started

Jan 2024

Finished

Jun 2026

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 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: * Voluntary acceptance to sign the informed consent form and commitment to attend all scheduled visits, follow the treatment plan, undergo medical evaluations, and complete all procedures of the clinical trial. * Participants must be between 40 and 70 years of age at the time of signing the informed consent form. * Clinical and radiographic diagnosis of primary knee osteoarthritis, Kellgren-Lawrence grade II and III. The reference radiographic study for Kellgren-Lawrence stratification must be no more than 6 months old. * Presence of knee joint pain with an intensity ≥4 on a scale of 0 to 10 in question 1 of the average pain experienced during the last week of the assessment (Spanish version of the MOS Pain Severity Scale - MOS-PSS). * Failure of conservative non-pharmacological treatment. * Failure of pharmacological treatment with NSAIDs and/or failure of intra-articular corticosteroid treatment. * BMI ≥25 and \<45 kg/m². * Commitment to comply with the activities and procedures of the clinical trial in a timely manner. * Maintaining the diet and any physical activity performed by the participant prior to signing the informed consent form for the clinical trial, without radical or significant changes throughout the duration of this clinical trial. * Women of reproductive potential must use a highly effective method of family planning. Exclusion criteria: * Participants with high-impact physical activity. * Participants with acute arthritis of the knee. * Participants on anticoagulants or with any contraindication to intra-articular infiltration (skin infection); participants requiring prophylactic doses of ASA. * Participants treated with oral or injectable glucocorticoids within the last 90 days. * Participants who have undergone intra-articular infiltration with glucocorticoids or viscosupplementation within the last 90 days. * Participants who have undergone arthroscopy within the last 6 months. * Participants with secondary osteoarthritis: Acromegaly, Hemochromatosis, and Hemophilia. * Participants with coexisting Rheumatoid Arthritis, Axial or Peripheral Spondyloarthritis, Systemic Lupus Erythematosus, Fibromyalgia, or any other rheumatic disease that may cause secondary osteoarthritis. * History of allergy to hyaluronic acid derivatives or any component constituent of the study treatments. * Presence of varus or valgus deformity \>15 degrees, or a flexion contracture \>20 degrees. * Women undergoing estrogen replacement therapy. * Pregnant or breastfeeding women. * Presence of any disease that, in the investigator's judgment, predisposes the patient to an additional risk by participating in this clinical trial (poorly controlled disease, psychiatric disorders, cancer, etc.). * Immediate relatives (parents, spouses, siblings, children) of the research team, or any member of the research team (Conflict of interest).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan

    Mérida, Yucatán, 97130, Mexico

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