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New treatment option for Damaged Chondral or Osteochondral Area
Official title The HYALEX Pivotal Study
ClinicalTrials.gov ID: NCT06368700
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 70
You may be able to join if
- (Phase 1):
- 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.
You likely can't join if
- 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. Patient Orthopaedic Health Exclusions:
See the full eligibility criteria
- (Phase 1):
- 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.
- 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. 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 how well it works 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.
The study team makes the final eligibility decision.
Where it's taking place
- La Mesa, California, United States
- New Orleans, Louisiana, United States
- New York, New York, United States
- Portland, Oregon, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Mesa, California, United States; New Orleans, Louisiana, United States; New York, New York, United States; Portland, Oregon, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.