Second Line Treatment of Knee Osteochondral Lesion With Treated Osteochondral Graft

NCT02430558 | Terminated Phase 1 DMC

• 1 other identifier: 2015-A00002-47
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• improvement of IKDC score

  18 months

Secondary Outcomes (3)

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  18 months

• recellularization of tissue (arthroscopy and histology)

  18 months

• integration of the tissue by imagery

  18 months

Study Arms (1)

OD-PHOENIX

EXPERIMENTAL

treatment of 1 to 5 osteochondral allograft cylinders in mosaic

Biological: OD-PHOENIX

Interventions

OD-PHOENIX BIOLOGICAL

Decellularized, freeze-dried, irradiated osteochondral allograft

Also known as: Osteochondral allograft

OD-PHOENIX

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• TBF Genie Tissulaire: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2015
• First Posted: April 30, 2015
• Study Start: April 5, 2016
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: September 27, 2022

Record last verified: 2022-09