Cartilage InjuryNCT06344481
The Hyalex First-in-Human Study
A study testing Surgical (Hyalex Cartilage Knee Implant) in people with Cartilage Injury, run by Hyalex Orthopaedics, Inc. at 2 sites in Poland.
Trial summary
The Hyalex First-in-Human Study is a prospective, multicenter, open-label, single-arm, 2-phase, first-in-human study to evaluate the safety and technical performance of the HYALEX Knee Cartilage System for replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients who… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Cartilage Injury
- What is being tested?
- Surgical (Hyalex Cartilage Knee Implant)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesPoland
- Study dates
- 7 Mar 2024to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21-65 years.
- Body Mass Index (BMI) ≤ 35.
- Singular treatable joint surface lesion, ICRS Grade 3 or 4, located on the medial or lateral femoral condyle.
- Symptomatic, single treatable area 1 - 3.8cm2.
- Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale score between 20 and 65.
- Stable knee.
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- Non-responsive to a minimum of 3 weeks of conservative treatment, consisting of non-steroidal anti-inflammatory drugs and/or physical therapy.
- 21-65 years.
- Body Mass Index (BMI) ≤ 35.
- Up to three treatable joint surface lesion(s), ICRS Grade 3 or 4, located on the medial or lateral femoral condyle(s).
- Symptomatic total treatable area 1 - 10cm2.
- Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale score between 20 and 65.
- Stable knee.
- Non-responsive to a minimum of 3 weeks of conservative treatment, consisting of non-steroidal anti-inflammatory drugs and/or physical therapy.
Who cannot join
- HYALEX Implant, Surgical Technique, and Lesion Site Exclusions:
- Known allergy to polyurethanes, bone cement, acrylic, or titanium.
- Lack of 2mm of healthy cartilage (ICRS Grade 0 or 1) and 2mm of vital bone wall on all sides of the implant site.
- Osteochondral defect affecting subchondral bone more than 11mm in depth from adjacent non-defect articular surface.
- Bipolar cartilage lesions involving patellar or tibial lesions ICRS Grade 3 - 4 opposite the lesion intended for treatment.
- Insufficient bone stock or bone density determined intra-operatively preventing implant press fit.
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- Patient Orthopaedic Health Exclusions:
- Kellgren and Lawrence (KL) grade 3 or 4 on standing radiographs as defined:
- Hip-knee-ankle (HKA) angle of greater than +/- 5 degrees (varus or valgus malalignment > 5 degrees) on standing X-ray.
- Lack of normally functioning contralateral knee that restricts activity.
- Insufficiency fracture of the femoral condyle or tibial plateau.
- Recent Osteochondritis Dissecans within 1 year.
- Diagnosis of a concomitant knee injury which the investigator believes may interfere with study participation or confound effectiveness assessment.
- Any known systemic cartilage and/or bone disorder, such as but not limited to osteoporosis, chondrodysplasia or osteogenesis imperfecta.
- A symptomatic musculoskeletal condition in the lower limbs that could impede effectiveness measurements in the target knee.
- Any known tumor of the treatment knee.
- Prior radiation therapy to the knee joint.
- Clinically significant or symptomatic vascular or neurological disorder of the lower extremities affecting gait or function.
- Untreated ACL and/or PCL deficiency or complex ligamentous instability of the study knee according to IKDC Grade C (abnormal) or D (severely abnormal).
- Previous Surgery and Intervention Exclusions:
- Previous surgery in the past 6 months on the index knee except for:
- Diagnostic knee arthroscopy and/or debridement / chondroplasty, and
- Meniscectomy
- Previous intra-articular injections, including HA and steroids, within the last 3 months prior to the date of surgery.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Prospective, Multicenter, Single-Arm, 2-Phase First-in-Human Feasibility Study of the HYALEX® Cartilage System
The Hyalex First-in-Human Study is a prospective, multicenter, open-label, single-arm, 2-phase, first-in-human study to evaluate the safety and technical performance of the HYALEX Knee Cartilage System for replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients who require surgical treatment.
- Conditions
- Cartilage Injury
- Being tested
- Surgical (Hyalex Cartilage Knee Implant)
- Keywords
- Knee, Cartilage, Lesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical (Hyalex Cartilage Knee Implant)Device
Implantation of Hyalex Cartilage Knee Implant.
| Study group | Role | What they receive |
|---|---|---|
| Hyalex Cartilage System | Experimental | Implantation of Hyalex Cartilage Knee Implant Receives: Device: Surgical (Hyalex Cartilage Knee Implant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from implant rejection and infection.
Assess the safety (implant rejection, infection) and tolerability of the Hyalex Cartilage Implant.
Measured: Through 24 months.
Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) from baseline at 12 months.
The KOOS assesses patient pain, other symptoms, function in daily living, function in sport and recreation, and knee related quality of life. Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
Measured: Through 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start7 Mar 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hyalex Orthopaedics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marcin Domzalski, MD, Principal investigator, SPORTO, Łódź, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344481
- Sponsor's protocol ID
- CL-00003
- Status last verified
- Oct 2026
- First submitted
- 21 Mar 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-Arm, 2-Phase First-in-Human Feasibility Study of the HYALEX® Cartilage System
- ClinicalTrials.gov ID
- NCT06344481
- Acronym / sponsor ID
- CL-00003
- Conditions
- Cartilage Injury
- Keywords
- Knee, Cartilage, Lesion
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Hyalex Orthopaedics, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Hyalex First-in-Human Study is a prospective, multicenter, open-label, single-arm, 2-phase, first-in-human study to evaluate the safety and technical performance of the HYALEX Knee Cartilage System for replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients who require surgical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyalex Cartilage System | Experimental | Device: Surgical (Hyalex Cartilage Knee Implant)Implantation of Hyalex Cartilage Knee Implant |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 21-65 years.
- Body Mass Index (BMI) ≤ 35.
- Singular treatable joint surface lesion, ICRS Grade 3 or 4, located on the medial or lateral femoral condyle.
- Symptomatic, single treatable area 1 - 3.8cm2.
- Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale score between 20 and 65.
Key exclusion criteria (24 listed)
- Known allergy to polyurethanes, bone cement, acrylic, or titanium.
- Lack of 2mm of healthy cartilage (ICRS Grade 0 or 1) and 2mm of vital bone wall on all sides of the implant site.
- Osteochondral defect affecting subchondral bone more than 11mm in depth from adjacent non-defect articular surface.
- Bipolar cartilage lesions involving patellar or tibial lesions ICRS Grade 3 - 4 opposite the lesion intended for treatment.
- Insufficient bone stock or bone density determined intra-operatively preventing implant press fit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical (Hyalex Cartilage Knee Implant)Implantation of Hyalex Cartilage Knee Implant. | Device | Hyalex Cartilage System |
Primary outcome
Freedom from implant rejection and infection.
Time frame: Through 24 months.
Assess the safety (implant rejection, infection) and tolerability of the Hyalex Cartilage Implant.
Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) from baseline at 12 months.
Time frame: Through 12 months.
The KOOS assesses patient pain, other symptoms, function in daily living, function in sport and recreation, and knee related quality of life. Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcin Domzalski, MD principal investigator
SPORTO, Łódź, Poland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical (Hyalex Cartilage Knee Implant) in people with Cartilage Injury, run by Hyalex Orthopaedics, Inc. at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from implant rejection and infection. (time frame: Through 24 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.