Second Line Treatment of Knee Osteochondral Lesion With Treated Osteochondral Graft

NCT ID: NCT02430558

Last Updated: 2022-09-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-05
• Study Completion Date: 2021-06-15

Brief Summary

Patient with IKDC score < 65, pretreated with mosaicplasty or ACI ( with matrix or not) within > 18 months, with one or two osteochondral lesions are recruited to have treated osteochondral allografts in mosaicplasty.

Conditions

Cartilage Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OD-PHOENIX

treatment of 1 to 5 osteochondral allograft cylinders in mosaic

Group Type: EXPERIMENTAL

OD-PHOENIX

Intervention Type: BIOLOGICAL

Decellularized, freeze-dried, irradiated osteochondral allograft

Interventions

OD-PHOENIX

Decellularized, freeze-dried, irradiated osteochondral allograft

Intervention Type: BIOLOGICAL

Other Intervention Names

Osteochondral allograft

Eligibility Criteria

Inclusion Criteria

• Male and female patients between the ages of 18 and 55

• osteochondral lesions of the knee due to trauma or osteochondritis dissecans or removal treatment ( lesion post autograft)
• Osteochondral lesion > grade II- ICRS
• One lesion or 2 concomitant lesions (tibial plateau, patella and condyles )at least one lesion has been pretreated by mosaicplasy or ACI. These treatment would have to have been made at least 18 months before inclusion
• Presence of disabling and clinically meaningful symptoms (subjective IKDC < 65, no improvement for 3 months)
• No significant obesity (BMI < 30)
• Accompanying ligamentous and meniscal lesions, joint malalignment and patella femoral instability are authorized and corrected concurrently.
• Patient able to understand, sign and date the informed consent form
• Patient affiliated with a national health insurance system or who is the beneficiary of such as system
• Women of childbearing age may not be included in the clinical trial unless their pregnancy test is negative. If this test is negative, they will be asked to use an effective birth control method during the entire the study.

Exclusion Criteria

• - Pregnant or breast feeding women: Women of childbearing age will be asked to undergo a pregnancy test before being enrolled into the study and to use an effective birth control method.
• Presence of osteoarthritis, rheumatoid arthritis, any other condition of knee joint that, in the surgeon's opinion, is likely to compromise the allograft's outcome
• Excessive laxity or recurrent instability that could affect the score evaluation without concomitant ligamentoplasty
• Presence of an ulcerative disease, heavy smoking, tuberculosis, chronic psychiatric disorder or disease requiring long-term treatment with a medication that would affect bone or joint metabolism
• Persons with cancer or a history of cancer
• Persons deprived of their freedom by a judicial or administrative decision
• Adults subject to legal protection measures or who are unable to provide their consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TBF Genie Tissulaire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2015-A00002-47

Identifier Type: -

Identifier Source: org_study_id