NCT02736318

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2017

Longer than P75 for phase_1

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 13, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

January 27, 2017

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2021

Completed
Last Updated

January 14, 2022

Status Verified

December 1, 2021

Enrollment Period

4.6 years

First QC Date

April 1, 2016

Last Update Submit

December 28, 2021

Conditions

Talus Osteochondral Defect

Outcome Measures

Primary Outcomes (1)

  • 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 (3)

  • Clinical and functional improvement of the ankle by AOFAS score

    3 months, 6 months, 12 months, 18 months,24 months

  • Impairment improvement by FASS ( foot and ankle severity score)

    3 months, 6 months, 12 months, 18 months,24 months

  • Evaluate osteochondral graft integration with imaging

    12 months, 18 months, 24 monts

Study Arms (1)

processed osteochondral allograft

EXPERIMENTAL

Implantation of 1 to 3 osteochondral products in osteochondral lesion of talus.

Biological: OD-PHOENIX

Interventions

OD-PHOENIXBIOLOGICAL

Decellularized, freeze-dried, irradiated osteochondral allograft

Also known as: Osteochondral allograft
processed osteochondral allograft

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)
  • 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.

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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AZ Monica

Antwerp, 2100, Belgium

Location

Poriya Medical Center

Tiberias, 1528001, Israel

Location

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 1, 2016

First Posted

April 13, 2016

Study Start

January 27, 2017

Primary Completion

September 7, 2021

Study Completion

September 7, 2021

Last Updated

January 14, 2022

Record last verified: 2021-12

Locations

IL(1)BE(1)