OD-PHOENIX in Talus Osteochondral Lesion | NCT02736318

Studies
OD-PHOENIX in Talus Osteochondral Lesion

NCT02736318

Sponsor

TBF Genie Tissulaire

Status

Terminated

Last Update Posted

Jan 14, 2022Actual

Enrollment

12Actual

Phase

Phase 1Phase 2

Conditions

Talus Osteochondral Defect

Interventions

OD-PHOENIX

Countries

Belgium
Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low accrual rate

Expanded Access Info

Start Date

Jan 27, 2017Actual

Primary Completion Date

Sep 7, 2021Actual

Completion Date

Sep 7, 2021Actual

First Submitted Date

Apr 1, 2016

First Submission Date that Met QC Criteria

Apr 7, 2016

First Posted Date

Apr 13, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 28, 2021

Last Update Posted Date

Jan 14, 2022Actual

Description Module

Brief Summary

Treatment of osteochondral lesion of Talus with a devitalized viro-inativated sterile osteochondral graft. To avoid having to harvest autograft material from the knee, a processed allogeneic osteochondral can be used instead autograft. The surgical technique is to implant in the osteochondral defect one to three products in the defect.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
processed osteochondral allograft	Experimental	Implantation of 1 to 3 osteochondral products in osteochondral lesion of talus.	Biological: OD-PHOENIX

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OD-PHOENIX	Biological	Decellularized, freeze-dried, irradiated osteochondral allograft	processed osteochondral allograft

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determine the improvement in ankle function based on the OMAS at 24 months	questionnaire	3 months, 6 months, 12 months, 18 months, 24 months

Secondary Outcomes

Measure	Description	Time Frame
Clinical and functional improvement of the ankle by AOFAS score	questionnaire and clinical evaluation	3 months, 6 months, 12 months, 18 months,24 months
Impairment improvement by FASS ( foot and ankle severity score)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female patients between the ages of 18 and 50
Isolated osteochondral lesion of the talus due to trauma (fracture) or osteochondritis dissecans
Osteochondral lesion > Anderson Grade I (MRI)
1 to 3 cm2 lesion
Presence of disabling and clinically meaningful symptoms (subjective OMAS < 50)
Patient who has been treated previously for this lesion, except if this treatment consisted of autologous osteochondral grafting
No significant obesity (BMI < 30)
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.
Previous mosaicplasty treatment of this lesion
Fracture or bone defect or subchondral lesion without cartilage involvement, untreated osteonecrosis, collapse of talar dome
Presence of osteoarthritis, rheumatoid arthritis, excessive hindfoot deformity or any other condition of the talocural 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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
AZ Monica		Antwerp		2100	Belgium
Poriya Medical Center