Overview

The aim of the study is to compare whether JointRep® plus microfracture is more effective than microfracture alone when treating symptomatic focal articular cartilage lesions in the knee (femoral condyles or trochlea).

Eligibility

Inclusion Criteria:

• Be between 18-65 years old
• Have one or two focal articular cartilage lesion(s) (ICRS Grade 3 or 4A) on the femoral condyles or trochlea of the index knee; patellar tracking must be normal if the index lesion(s) is on the trochlea. Individually, a lesion can be between 2-7cm2. If more than one lesion is present, the sum of the two lesions should not exceed 10cm2.
• Within 6 months prior to treatment, have a Magnetic Resonance Imaging (MRI) or arthroscopic confirmation of lesion(s) in the index knee.
• For patients older than 40 y.o, to have a radiological Kellgren and Lawrence (K&L) grading from a standing knee radiograph taken less than 6 months previously, Grade 1 or
• If not, an actual test will be performed as part of the visit 1 procedures.
• Have a clinically stable knee, with no ligament deficiencies (<5mm side-to-side difference on Lachman and varus/valgus stress testing & Grade 0 or 1 on Pivot shift test) and the meniscal rims are intact (a maximum of 50% resection is allowed)
• Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
• VAS pain great than or equal to 4 in the last week.
• Be willing and able to comply with all study procedures including all preoperative, post-operative and rehabilitation requirements
• If female and of child-bearing potential, must report double-barrier, contraceptive use (e.g. use of birth-control pill and condom) for at least 2 months prior to treatment and in the 12 months following treatment.
• If female and of child-bearing potential, have a negative pregnancy test prior to the surgical procedure and no intention of becoming pregnant in the 12 months following treatment.

Exclusion Criteria:

• Have a Body Mass Index (BMI) >35kg/m2
• Have more than two lesions (ICRS grade 3 or 4A) on any surface in the index knee
• Have "kissing" or opposing lesion(s) (ICRS grade 3 or 4A) of the condyle, tibia or patella in the index knee; additional linear lesions which bear Grade 3 or 4 characteristics may be acceptable if they are determined by the Investigator to be incidental, not clinically relevant, and consistent with the subject demographic
• Have malalignment of >5 degrees varus or valgus in the index knee based on standard AP x-rays requiring an osteotomy
• Have had any surgical treatment for cartilage repair in the index knee within 1 year prior to treatment
• Have had intra-articular injections within 3 months in the index knee
• Have a diagnosis of a concomitant knee injury which may confound assessment of the index knee (e.g., important meniscal injury)
• Have significant pain emanating from other lower body joints in the ipsilateral (hip, ankle) or contralateral (hip, knee, ankle) limb.
• Have known allergies to shellfish
• Have a known history of crystalloid or inflammatory arthropathy
• Have any condition that is unrelated to the index knee and significantly impairs walking ability (e.g., spinal stenosis, sciatica)
• Have advanced musculoskeletal disease
• Have active coagulation disorders
• Are currently using antibiotics
• Are participating concurrently in another clinical investigation, or have participated in a clinical investigation within the last 90 days, or intend to participate in another clinical investigation during the course of the study
• Are currently abusing drugs or alcohol or have a history of the same within the last 12 months
• Have any mental or psychological disorder that would impair their ability to complete the study questionnaires
• Are currently breastfeeding or planning to breastfeed any time during the course of the study
• Are currently a prisoner
• Have significant comorbidities or conditions associated with high-risk for surgical or anesthetic survival (e.g., renal failure, peripheral vascular disease, unstable cardiac disease, poorly controlled diabetes, immunosuppression, etc.)
• Have any medical condition or other circumstances, in the judgment of the investigator, that might interfere with the ability to return for follow-up visits, including any systemic illness, neuromuscular, neurosensory, or musculoskeletal deficiency that would render the subject unable to perform appropriate post-operative rehabilitation
• Have any condition which, in the judgment of the Investigator, would preclude adequate evaluation of the device's safety and performance

Intra-operative Exclusion Criteria:

        Subjects who meet any of the following intra-operative screening criteria will be excluded
        from participation in this study:
          -  Have lesion(s) in the index knee that are not contained (intact shoulders) and/or
             exceed 7 cm² in total size after debridement for a single lesion and 10cm2 for more
             than one lesion, if within the same condyle or the trochlea. If only a single lesion
             suitable to be included is identified, it might be between 2-7cm2.
          -  Minor concomitant procedures are allowed such as, but not limited to:
               1. Removal of loose bodies
               2. Plica excision
               3. Minor synovial removing
               4. Minor chondroplasty (debridement)
               5. Lysis of adhesions
               6. Meniscal trimming/suturing which respects the exclusion criteria.