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Chondro-Gide® for Knee Cartilage Injury (SECURE Trial)

N/A
Recruiting
Led By Kevin Plancher, MD
Research Sponsored by Geistlich Pharma AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
One symptomatic knee with cartilage defect on the medial femoral condyle, lateral femoral condyle, or trochlea, identified MRI or arthroscopy
Between 18 and 55 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
Awards & highlights

SECURE Trial Summary

This trial found that treating large chondral lesions in the knee with microfracture plus the Chondro-Gide® ACC is non-inferior to treating small chondral lesions treated with microfracture alone.

Who is the study for?
This trial is for individuals aged 18-55 with knee pain due to cartilage defects, who can follow the study's procedures and rehab protocol. They must not be overweight (BMI <30), have no severe knee issues on the other side, no allergies to porcine collagen, or recent treatments that could affect results like steroids or joint injections.Check my eligibility
What is being tested?
The study tests if treating large knee cartilage lesions with microfracture surgery plus Chondro-Gide® ACC is as effective as treating smaller lesions with just microfracture. It's a multi-center, non-randomized trial where patients and assessors don't know which treatment was given.See study design
What are the potential side effects?
Possible side effects may include discomfort at the surgery site, swelling in the knee, allergic reactions to materials used (if there's an unknown allergy), and typical surgical risks such as infection.

SECURE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a knee injury identified by MRI or arthroscopy.
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I am between 18 and 55 years old.
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I am willing and able to follow all study requirements.

SECURE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patients achieving composite clinical success (CCS) at 24 months follow-up, with CCS
Secondary outcome measures
Employment status
EuroQol-5 Dimension (EQ-5D)
Knee Injury and Osteoarthritis Outcome Score
+3 more

SECURE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Investigational GroupExperimental Treatment1 Intervention
Patients with large chondral lesions of the knee
Group II: Control ArmActive Control1 Intervention
Patients with small chondral lesions of the knee

Find a Location

Who is running the clinical trial?

Telos PartnersUNKNOWN
Geistlich Pharma AGLead Sponsor
41 Previous Clinical Trials
1,842 Total Patients Enrolled
1 Trials studying Cartilage Injury
67 Patients Enrolled for Cartilage Injury
Despoina Natsiou Schmiady, PhDStudy DirectorGeistlich Pharma AG

Media Library

Microfracture Clinical Trial Eligibility Overview. Trial Name: NCT04537013 — N/A
Cartilage Injury Research Study Groups: Investigational Group, Control Arm
Cartilage Injury Clinical Trial 2023: Microfracture Highlights & Side Effects. Trial Name: NCT04537013 — N/A
Microfracture 2023 Treatment Timeline for Medical Study. Trial Name: NCT04537013 — N/A
Cartilage Injury Patient Testimony for trial: Trial Name: NCT04537013 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the program currently recruiting participants?

"Affirmative. Clinicaltrials.gov suggests this experiment is currently recruiting for participants, which was initially announced on August 26th 2020 and most recently updated on January 3rd 2022. The study requires the recruitment of 234 patients from 7 different medical sites."

Answered by AI

To what extent has this trial recruited participants?

"Affirmative. This medical trial is still enrolling participants, as evidenced by the records on clinicaltrials.gov which were first posted on August 26th 2020 and edited most recently on January 3rd 2022. The study seeks to recruit 234 subjects from seven different sites across America."

Answered by AI

Is this clinical research accommodating individuals older than 55 years of age?

"The age bracket that is eligible to partake in this trial sits between 18 and 55. However, there are 129 separate studies dedicated to minors and 608 clinical trials for seniors."

Answered by AI

Do I conform to the criteria for enrollment in this inquiry?

"Those with chondromalacia and aged between 18-55 may register for this clinical trial, which is slated to accept 234 participants."

Answered by AI

Can you tell me how many Canadian medical facilities are engaging in this clinical research?

"This study is recruiting participants across 7 different sites, amongst them St. Joseph's Healthcare Hamilton in Hamilton, MedStar Orthopaedics Institute in Timonium and CORE Orthopaedic Medical Center in Encinitas."

Answered by AI

Who else is applying?

What state do they live in?
California
Ontario
What site did they apply to?
CORE Orthopaedic Medical Center
St. Joseph's Healthcare Hamilton
Other
University of Toronto Orthopaedics
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

I would like to know more about my condition. I have had 4 knee surgeries on my right knee. 2 ACL repairs and 2 menisectomies. My knee, after countless hours of rehab, still does not feel stable during sports.
PatientReceived no prior treatments
~33 spots leftby Nov 2024