New Trial – Collagen Scaffold for Repair of Talus Cartilage Injury

Trial at a glance

• Sponsor: Beijing Jishuitan Hospital, China.
• Phase/Status: Phase 3; enrolling by invitation.
• Indication: Talus cartilage damage in adults aged 18–55 who have not responded to conservative treatments; estimated enrollment of 40 participants.
• Arms/Dosing: Microfracture surgery plus implantation of Collagen Scaffold (Colla-Plug). The scaffold (COLTRIX® CartiRegen) consists of an injection needle, a syringe and prefilled collagen gel containing phosphate buffer and type I collagen with telopeptides removed.
• Control: Microfracture surgery alone (active comparator).
• Endpoints: Primary: MOCART score assessing cartilage repair, preoperatively and at 3 and 6 months and 1 and 2 years postoperatively. Secondary: range of motion and Visual Analogue Scale pain score, preoperatively and at 1 week, 1 month, 3 months, 6 months, 1 year and 2 years postoperatively.
• Timing: Actual start: October 1, 2026; estimated primary completion: August 1, 2028; estimated study completion: August 1, 2028.

Trial Summary

ClinicalTrials.gov lists the following summary for the study:

The goal of this clinical trial is to test whether adding a collagen protein scaffold can improve cartilage repair of talus injury, compared to standard surgery alone. The study will enroll 40 patients (aged 18-55) with talus cartilage damage who haven’t responded to conservative treatments.

The main questions it aims to answer are:

* Does the collagen scaffold help regenerate better-quality cartilage (measured by MRI scans at 3/6 months and 1/2 years)?

* Do patients experience better pain relief and ankle function after this combined treatment?

Researchers will compare two groups:

* Experimental group: Receives microfracture surgery + collagen scaffold implant

* Active Comparator group: Receives microfracture surgery alone

Participants will:

* Undergo arthroscopic surgery (either procedure)

* Complete follow-up visits at 1 week, 1 month, 3 months, 6 months, 1 year and 2 years

* Have MRI scans and functional assessments

* Report pain levels and daily activity limitations through questionnaires

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