Second Line Treatment of Knee Osteochondral Lesion With Treated Osteochondral Graft

Cartilage Injury Clinical Trial

— ODPHOENIX2  

Official title:

Second Line Treatment of Knee Osteochondral Lesion With Decellularized Treated Osteochondral Allograft. Phase IIa Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02430558
• Other study ID #: 2015-A00002-47
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: April 5, 2016
• Est. completion date: June 15, 2021

Study information

• Verified date: September 2022
• Source: TBF Genie Tissulaire
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: June 15, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cartilage Injury

Intervention

Biological:
• OD-PHOENIX
Decellularized, freeze-dried, irradiated osteochondral allograft

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
TBF Genie Tissulaire

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement of IKDC score		18 months
Secondary	Knee Injury and Osteoarthritis Outcome Score (KOOS)		18 months
Secondary	recellularization of tissue (arthroscopy and histology)	arthroscopy and histology	18 months
Secondary	integration of the tissue by imagery		18 months