Damaged Chondral or Osteochondral AreaNCT06368700
The HYALEX Pivotal Study
A study testing Hyalex Knee Cartilage System in people with Damaged Chondral or Osteochondral Area, run by Hyalex Orthopaedics, Inc. at 5 sites in United States.
Trial summary
A multicenter, open-label, single-arm, pivotal study to evaluate the safety and effectiveness of the HYALEX Freestyle Resurfacing System for replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients who require surgical treatment, will be enrolled in the study and undergo… Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Damaged Chondral or Osteochondral Area
- What is being tested?
- Hyalex Knee Cartilage System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 5 sitesUnited States
- Study dates
- 4 Apr 2024to Dec 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 22 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 22-70 years.
- Body Mass Index (BMI) ≤ 40.
- Up to two treatable joint surface lesion, ICRS Grade 3 or 4, located on the medial and/or lateral femoral condyle.
- Up to 2 implants (one implant per condyle) to treat up to 2 individual symptomatic lesions with a total summative area up to 4.52cm2 / condyle.
- Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale score between 20 and 65.
- Ligamentously stable knee.
- Failure of non-operative treatment (e.g., physical therapy, physician-directed at home exercise program, intra-articular injections, bracing) for at least 4 months prior to consideration for participation in the study.
Who cannot join
- HYALEX Implant, Surgical Technique, and Lesion Site Exclusions:
- Known allergy to polyurethanes, bone cement, acrylic, or titanium.
- Lack of 2mm of cartilage (ICRS Grade 0 to 2) 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.
Show all 21Show fewer
- Patient Orthopaedic Health Exclusions:
- Kellgren and Lawrence (KL) grade 3 or 4 on standing radiographs.
- Hip-knee-ankle (HKA) angle of greater than +/- 8 degrees (varus or valgus malalignment > 8 degrees) on standing X-ray.
- Lack of normally functioning contralateral knee that restricts activity.
- 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.
- 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 surgical cartilage treatment in the index knee within the last 6 months
- Previous intra-articular injections, including HA and steroids, within the last 3 months prior to the date of surgery.
- Patient Overall Health and Health History Exclusions:
- Any known history of inflammatory arthropathy or untreated or uncontrolled crystal-deposition arthropathy.
- Current cigarette smoker or user of other nicotine products.
- Known Type 1 or Type 2 insulin-dependent diabetes mellitus.
- Currently undergoing immunosuppressive therapy or long-term steroid use (corticosteroid, excluding inhalers) or within 3 months prior to surgery.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 4 recruiting
- Recruiting
The Ohio State University Wexner Medical Center - Sports Medicine
Columbus, Ohio, 43202
Jenna DeFranco, 614-293-2761, jenna.defranco@osumc.edu
Jelle van der List, M.D.
- Recruiting
Horizon Clinical Research
La Mesa, California, 91942
Dino Subasic, (619) 456-6012 ext. 1, dino@horizontrials.com
Scott Hacker, M.D.
- Recruiting
Ochsner Sports Medicine Institute
New Orleans, Louisiana, 70121
Joseph Laurent, (504) 842-0263, joseph.laurent@ochsner.org
Brian Godshaw, M.D.
- Completed
Hospital for Special Surgery
New York, New York, 10021
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Jessica Ballin, 503-418-9580, ballin@ohsu.edu
Dennis Crawford, M.D.
About this study
Official title: The HYALEX Freestyle™ Resurfacing System Pivotal Study: A Multicenter, Single-Arm, Pivotal Study of the HYALEX Freestyle Resurfacing Implant
A multicenter, open-label, single-arm, pivotal study to evaluate the safety and effectiveness of the HYALEX Freestyle Resurfacing System for replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients who require surgical treatment, will be enrolled in the study and undergo implantation of the HYALEX Freestyle Resurfacing Implant.
- Conditions
- Damaged Chondral or Osteochondral Area
- Being tested
- Hyalex Knee Cartilage System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyalex Knee Cartilage SystemDevice
Surgical implantation of the Hyalex Knee Cartilage System
| Study group | Role | What they receive |
|---|---|---|
| HYALEX Freestyle Resurfacing System | Experimental | Implantation of the HYALEX Implant Receives: Device: Hyalex Knee Cartilage System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Primary Endpoint
- A clinically significant improvement in KOOS Pain score;
- A clinically significant improvement in KOOS ADL score;
- Lack of treatment-related SAEs; and
- Absence of secondary surgical intervention defined as HYALEX Freestyle Resurfacing Implant removal or revision due to a treatment-related finding.
Measured: 12 months
Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) 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: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start4 Apr 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Damaged Chondral or Osteochondral AreaStudies 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
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hyalex Orthopaedics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368700
- Sponsor's protocol ID
- CL-00001
- Status last verified
- Apr 2026
- First submitted
- 11 Apr 2024
- Last updated
- 7 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 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HYALEX Freestyle™ Resurfacing System Pivotal Study: A Multicenter, Single-Arm, Pivotal Study of the HYALEX Freestyle Resurfacing Implant
- ClinicalTrials.gov ID
- NCT06368700
- Acronym / sponsor ID
- CL-00001
- Conditions
- Damaged Chondral or Osteochondral Area
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Hyalex Orthopaedics, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 16 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.
A multicenter, open-label, single-arm, pivotal study to evaluate the safety and effectiveness of the HYALEX Freestyle Resurfacing System for replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients who require surgical treatment, will be enrolled in the study and undergo implantation of the HYALEX Freestyle Resurfacing Implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HYALEX Freestyle Resurfacing System | Experimental | Device: Hyalex Knee Cartilage SystemImplantation of the HYALEX Implant |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 22-70 years.
- Body Mass Index (BMI) ≤ 40.
- Up to two treatable joint surface lesion, ICRS Grade 3 or 4, located on the medial and/or lateral femoral condyle.
- Up to 2 implants (one implant per condyle) to treat up to 2 individual symptomatic lesions with a total summative area up to 4.52cm2 / condyle.
- Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale score between 20 and 65.
Key exclusion criteria (21 listed)
- Known allergy to polyurethanes, bone cement, acrylic, or titanium.
- Lack of 2mm of cartilage (ICRS Grade 0 to 2) 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 |
|---|---|---|
| Hyalex Knee Cartilage SystemSurgical implantation of the Hyalex Knee Cartilage System | Device | HYALEX Freestyle Resurfacing System |
Primary outcome
Composite Primary Endpoint
Time frame: 12 months
* A clinically significant improvement in KOOS Pain score; * A clinically significant improvement in KOOS ADL score; * Lack of treatment-related SAEs; and * Absence of secondary surgical intervention defined as HYALEX Freestyle Resurfacing Implant removal or revision due to a treatment-related finding.
Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) at 12 months.
Time frame: 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 7 Oct 2026.
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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyalex Knee Cartilage System in people with Damaged Chondral or Osteochondral Area, run by Hyalex Orthopaedics, Inc. at 5 sites in United States.
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 7 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 7 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 5 sites in United States. 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?
Contact Chris Cain (408-439-5154, chris.cain@hyalex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Primary Endpoint (time frame: 12 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 7 Oct 2026.