Health TrialsbyHealthPanel

EB-OC for the Treatment of Focal Chondral/Osteochondral Defects in the Knee

ConditionsChondral DefectOsteochondral Defect
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEpibone, Inc.

About this trial

EB-OC is a tissue engineered osteochondral tissue graft comprising of a living tissue engineered cartilage layer attaching to a bone scaffold. The goal of this clinical trial is to learn about in the safety and efficacy of the EB-OC graft in participants who require repair of chondral/osteochondral defects of the knee. The main question it aims to answer is if the EB-OC graft works to regenerate osteochondral tissue comprising of native hyaline cartilage anchors to the regenerated bone. Participants will receive treatment of either the EB-OC Graft implantation in an arthrotomy procedure or abrasion chondroplasty. Researchers will compare results from the EB-OC graft to abrasion chondroplasty to assess overall safety and effectiveness.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Subject is male or female, between 18 and 65 years of age

Subject's body mass index (BMI) is ≤ 35 kg/m2.

Located on the femoral condyles or femoral trochlea

Each between 0.75 and 3 cm2 in area on screening images as confirmed by an independent radiologist

Disqualifiers

Lesions on the opposing surface of the tibia that are classified as ICRS grade 3 or 4.

Lesions on the opposing surface of the patella that are classified as ICRS grade 3 or 4 if a trochlear defect is being treated.

Any existing prosthetic implants in the index knee.

History of knee surgery in the index knee within 6 months prior to screening.

Trial design

Design model

Parallel

Treatments tested in this trial

  • EB-OC Graft Implantation

    Device

    The implantation of the EB-OC graft is completed via an arthrotomy, which is categorized as a minor surgery and is done on an outpatient basis, which means you can go home the same day. It is completed under general anesthesia and may last between one to two hours.

  • Abrasion chondroplasty

    Procedure/Surgery

    Abrasion chondroplasty is a minimally invasive procedure in which the surgeon uses a rotary burr to scrape off the bone tissue from the surface of the joint.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: EB-OC graftExperimental treatment 1 intervention
Group B: Abrasion ChondroplastyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of adverse event incidents as compared to control

Number of adverse event incidents based on clinical laboratory and vital signs during the 12-month period post-surgery as compared to control

Time frame
12 months
2

Adverse event incident rate (% pateint) as compared to control

Adverse event incident rate (% patient) based on clinical laboratory and vital signs during the 12-month period post-surgery as compared to control

Time frame
12 months
3

Number of adverse events based on electrocardiogram readout as compared to control

Number of adverse events based on Electrocardiogram (ECG) readout as compared to control

Time frame
Day 1, 1 week post Surgery
4

Incident rate of adverse event (% patient) based on electrocardiogram readout as compared to control

Incident rate of adverse event (% patient) based on Electrocardiogram (ECG) readout as compared to control

Time frame
Day 1, 1 week post Surgery

Secondary outcomes

1

Patient reported outcome KOOS scores

KOOS scores which assesses Pain, Symptoms, Activities of Daily Living, Sport and Recreation Function, and Quality of Life. Score of 0-100 with zero being worst and 100 being best outcome

Time frame
5 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
2

Patient reported outcome IKDC scores

IKDC Score (Subjective Knee Evaluation, Evaluator Global Assessment and Patient Global Assessment). Score of 0-100 with zero being worst and 100 being best outcome

Time frame
5 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
3

MRI AMADEUS score

MRI AMADEUS score of the treated defect at Screening. Score 0-100 with 0 represents worst case cartilage defect and 100 represents best intact cartilage and bone

Time frame
Screening, 12 months
4

MRI MOCART score

MRI MOCART scoring of the treated defect. Score ranging from 0-100 with 0 being worst and 100 being best.

Time frame
12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Epibone, Inc.

Lead sponsor

MCRA

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: