Ten Years Follow-up After the Arthroscopic Repair of Osteochondral Lesions of the Talus Via Autologous Matrix-induced Chondrogenesis (AMIC) (AMIC10Y)

This clinical study evaluates the long-term, ten-year clinical and functional outcomes of patients who underwent arthroscopic repair of osteochondral lesions of the talus (OLT) using the autologous matrix-induced chondrogenesis (AMIC) technique. Conducted at the IRCCS Ospedale Galeazzi Sant'Ambrogio in Milan, the research addresses a critical gap in current medical literature. While the AMIC procedure is widely utilized to treat these challenging lesions, consolidated very long-term data at the ten-year mark remains scarce. Consequently, this study aims to verify whether the positive clinical benefits previously observed in the short and medium term remain stable over time or if they undergo a significant deterioration. The project will span a total duration of six months, analyzing a sample size of approximately 40 patients who received this specific treatment between April 2013 and April 2016.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteochondral Defect of Talus

Detailed Description

The target population for this investigation consists of patients treated for osteochondral defects of the talus at the IRCCS Ospedale Galeazzi Sant'Ambrogio within the specified timeframe from April 2013 to April 2016. To be eligible for inclusion, patients must have undergone the repair procedure via the AMIC technique utilizing a specific porcine collagen I/III membrane, commercially known as Chondro-Gide. Conversely, the study excludes individuals with irrelevant post-operative diagnoses, such as pigmented villonodular synovitis, as well as cases where it is impossible to retrieve the necessary follow-up data.The study protocol relies on the retrospective and longitudinal analysis of clinical and functional outpatient data gathered at four distinct time points. These checkpoints consist of a pre-operative baseline assessment followed by three post-operative follow-up evaluations conducted at one year, five years, and ten years. Throughout these intervals, patient pain levels are quantified using the Visual Analog Scale. Functional and clinical outcomes are measured through the American Orthopaedic Foot and Ankle Score to determine overall functionality, and the 17-item Italian Foot Function Index to evaluate disability and functional limitations. Additionally, the European Foot and Ankle Score is administered specifically at the five and ten-year follow-ups to provide further validation aligned with the most recent international standards. Safety and procedure survival are also strictly monitored by recording all complications, clinical failures, and surgical revisions that occurred over the ten-year span. Finally, demographic and biometric data-including age at surgery, sex, BMI, smoking habits, and lesion characteristics such as localization and volume-are gathered to perform correlation analyses.The statistical approach is designed around the primary objective of evaluating clinical parameters across the four established time points. This will be achieved by measuring within-patient effects using a one-way repeated measures ANOVA. The sample size calculation was performed assuming a medium effect size of Cohen's $d = 0.3$, which corresponds to $\eta^2 = 0.059$. With a Type I error ($\alpha$) set at 0.05, a statistical power of 0.9, and a within-subject correlation of measures of 0.5, the minimum required sample size was determined to be 30 subjects. To safely account for a potential 20% rate of patient dropouts and missing data, this requirement was increased to 38 subjects, which aligns with the planned cohort of approximately 40 patients. All sample size calculations were executed using R software, version 4.5.2, utilizing the pwrss package, version 1.0.0.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy
    • IRCCS Ospedale Galeazzi-Sant'Ambrogio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients treated for OLT between April 2013 and April 2016 at the IRCCS Ospedale Galeazzi Sant'Ambrogio.

Description

Inclusion Criteria:

- Patients who underwent repair of an osteochondral defect via the AMIC® procedure utilizing a porcine collagen I/III membrane (Chondro-Gide®).

Exclusion Criteria:

- Irrelevant post-operative diagnoses (e.g., pigmented villonodular synovitis) or the inability to retrieve follow-up data.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ten years follow-up after the arthroscopic repair of osteochondral lesions of the talus via autologous matrix-induced chondrogenesis (AMIC)	Clinical Outcomes (AOFAS - VAS)	10 years

Collaborators and Investigators

• Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2026
• Primary Completion (Actual): July 21, 2026
• Study Completion (Estimated): September 21, 2026

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Cartilage repair
• Other Study ID Numbers: CET 261-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No