NCT06915233Phase 3Recruiting

A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2030-07Estimated

Enrollment · participants309Estimated

Source updated2026-07-23Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2025-12-18 · 2 fields changed

Primary completion date changed

− Before

~~Apr 2030~~

+ After

Jul 2030

Recruitment status changed

− Before

~~Not yet recruiting~~

+ After

Recruiting

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Study details

Conditions studied

Chondral Defect; Articular Cartilage Defect

Treatments or interventions studied

autologous cultured chondrocytes on porcine collagen membraneBiological

Primary outcomes · main study measures

Read the study measures

measure: Change from Baseline to Week 104 in the FAOS Pain and Function (SRA) subscale scores; description: The FAOS is a 42-item, patient-reported outcome measure that assesses foot and ankle health in the past week. There are five FAOS subscales: Pain, Symptoms, Function (Daily Living), Function (SRA), and Foot and Ankle Related Quality of Life. The FAOS has been validated for a variety of foot and ankle conditions, including OLT. Responses to each question on the FAOS are recorded on a 5-point Likert scale. A normalized score out of 100 is calculated for each subscale, with 0 indicating extreme symptoms and 100 no symptoms. Selection of this composite primary endpoint is consistent with FDA guidance recommending selection of primary endpoints that evaluate changes in Pain and Function (SRA) subscale scores as they represent clinically meaningful outcomes for participants who receive products intended to repair or replace damaged cartilage in the knee.; timeFrame: Baseline to Week 104

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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