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A Study of Collagen Scaffold for the Repair of Elbow Cartilage Injury

NCT07149896 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-09-02

No results posted yet for this study

Summary

The goal of this clinical trial is to test whether adding a collagen protein scaffold can improve cartilage repair in elbow joint injuries, compared to standard surgery alone. The study will enroll 90 patients (aged 18-55) with elbow 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 and 6 months)?
* Do patients experience better pain relief and elbow 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, and 6 months
* Have MRI scans and functional assessments
* Report pain levels and daily activity limitations through questionnaires

Conditions

  • Cartilage Defect
  • Elbow Injury

Interventions

DEVICE

Collagen Scaffold (Colla-Plug)

The collagen cartilage scaffold(COLTRIX® CartiRegen) used in this study consist of an injection needle, a syringe, and a collagen gel prefilled in a syringe. The collagen gel contains phosphate buffer and type Ⅰ collagen which the telopeptides are removed.. After the product is implanted in the body, it forms a degradable three-dimensional scaffold to provide an environment for cells to adhere, proliferate, migrate, differentiate and secrete, thereby promoting cartilage repair. At present, it has been commercially applied to clinical repair of knee cartilage defect.

PROCEDURE

microfracture

Microfracture to repair cartilage defect is a minimally invasive procedure that is usually done arthroscopically. The doctor first cleans the damaged cartilage area, and then uses a special microfracture cone to drill vertically in the subchondral bone plate, forming multiple tiny holes, allowing mesenchymal stem cells and growth factors in the bone marrow to overflow, forming a blood clot rich in repair components, and finally stimulating fibrocartilage regeneration to fill the defect area.

Sponsors & Collaborators

  • Beijing Jishuitan Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07149896 on ClinicalTrials.gov