Chondro-Gide® for Knee Cartilage Injury

(SECURE Trial)

Not currently recruiting at 20 trial locations

Overseen By Kevin Plancher, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Geistlich Pharma AG

Must not be taking: Steroids, Immunosuppressants, Chemotherapy, others

Disqualifiers: Obesity, Osteoarthritis, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for treating knee cartilage injuries using microfracture (an articular cartilage repair technique), with or without a special cover called Chondro-Gide®. The researchers aim to determine if treating larger cartilage injuries with this cover is as effective as treating smaller injuries without it. The study seeks participants who have experienced knee pain from cartilage damage for less than three years and have not undergone certain types of knee surgery. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance future treatment options for knee cartilage injuries.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using certain treatments like radiation, chemotherapy, immunosuppression, or high-dose steroids. Also, you must not have used intra-articular steroids or other injections in the knee within 3 months before joining.

What prior data suggests that the Chondro-Gide® ACC is safe for treating knee cartilage injuries?

Research has shown that the Chondro-Gide® collagen membrane is generally safe for knee cartilage repair. Studies have found that it can improve pain and knee function when combined with microfracture surgery. In one study, patients using Chondro-Gide® reported better pain relief and knee function over two years. However, like any medical procedure, risks exist, though specific side effects are not often detailed in the research.

Microfracture is a common procedure for addressing knee cartilage issues. Most evidence for its safety and effectiveness comes from detailed patient reports. Some studies have noted it may not be as effective as other treatments, but it is generally considered safe. Both treatments have been tested in various studies, indicating they are well-tolerated by many patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for knee cartilage injuries, which often involve traditional surgery or physical therapy, the use of Chondro-Gide® with microfracture offers a novel approach by combining a biological scaffold with a minimally invasive technique. Researchers are excited about this treatment because the Chondro-Gide® scaffold provides a supportive environment for new cartilage growth, potentially enhancing the healing process and improving outcomes over time. This combination could lead to faster recovery and better long-term knee function compared to conventional methods.

What evidence suggests that Chondro-Gide® ACC is effective for knee cartilage injury?

Research has shown that Chondro-Gide® can improve knee function, with many patients benefiting for up to 10 years after treatment. In the first two years, 67% to 85% of patients reported better knee function. In this trial, participants in the investigational group will receive Chondro-Gide® for large chondral lesions. The control arm will receive microfracture treatment, which is effective, especially for smaller knee injuries, leading to significant improvements. However, larger injuries might not heal as effectively with microfracture alone. Combining microfracture with Chondro-Gide® may offer a promising option for treating larger knee cartilage injuries. ^{1 3 4 6 7}

Who Is on the Research Team?

Fabiana Martinelli

Principal Investigator

Geistlich Pharma AG

Kevin Plancher, MD

Principal Investigator

Plancher Orthopedics and Sports Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Signed written informed consent

I have a knee injury identified by MRI or arthroscopy.

I am willing and able to follow all study requirements.

Exclusion Criteria

You have a history of drug or alcohol abuse, as defined by the DSM-V.

You are allergic to porcine collagen.

Enrolled in another study, involved in the study (as a researcher/investigator/sponsor), or relative of someone directly involved in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Eligible patients with large chondral lesions will be treated with microfracture plus the Chondro-Gide® ACC, while control patients with small lesions will be treated with microfracture alone.

6 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including KOOS, IKDC, and MOCART scores.

24 months

Multiple visits at 3, 6, 12, 18, and 24 months (in-person and virtual)

Long-term follow-up

Continued monitoring of patient outcomes and adverse events beyond the primary follow-up period.

Additional 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Chondro-Gide® ACC
• Microfracture

Trial Overview 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.

How Is the Trial Designed?

Group I: Investigational Group Experimental Treatment 1 Intervention

Patients with large chondral lesions of the knee

Group II: Control Arm Active Control 1 Intervention

Patients with small chondral lesions of the knee

Microfracture is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Microfracture for:

• Symptomatic focal articular cartilage lesions in the knee (femoral condyles or trochlea)

Approved in European Union as Microfracture for:

• Full-thickness defects or loss of the articular surface of a joint, usually the knee joint

Approved in Canada as Microfracture for:

• Damaged articular cartilage of the knee

Who Is Running the Clinical Trial?

Geistlich Pharma AG

Lead Sponsor

Trials

45

Recruited

2,300+

Telos Partners

Collaborator

Trials

1

Recruited

230+

Published Research Related to This Trial

Microfracture surgery for knee cartilage repair led to significant functional improvement in 67% of patients after at least two years, with better outcomes linked to good repair-tissue fill and lower body-mass index.

Patients with a body-mass index over 30 kg/m² experienced worse results, and those with symptoms lasting less than twelve months before surgery had more frequent improvements in daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The microfracture technique for the treatment of articular cartilage lesions in the knee. A prospective cohort study. Mithoefer, K., Williams, RJ., Warren, RF., et al.[2022]

Microfracture surgery for knee cartilage repair led to significant functional improvements in 67% of patients after at least two years, with better outcomes linked to good repair-tissue fill and lower body-mass index.

Patients with a body-mass index over 30 kg/m² and those with longer preoperative symptom durations experienced poorer outcomes, highlighting the importance of these factors in predicting recovery success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chondral resurfacing of articular cartilage defects in the knee with the microfracture technique. Surgical technique. Mithoefer, K., Williams, RJ., Warren, RF., et al.[2022]

A systematic review of five comparative studies involving autologous chondrocyte implantation (ACI) and microfracture for knee cartilage lesions showed that both treatments significantly improve clinical outcomes after 5 years.

Modified versions of ACI, such as ACI with a collagen membrane (ACI-C) or matrix-applied chondrocyte implantation (MACI), resulted in better clinical results compared to microfracture, although the treatment failure rates were similar between the two methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is implantation of autologous chondrocytes superior to microfracture for articular-cartilage defects of the knee? A systematic review of 5-year follow-up data. Na, Y., Shi, Y., Liu, W., et al.[2019]

A randomized controlled trial involving 38 patients with medium-sized cartilage defects (average size 3.4 cm²) showed that Autologous Matrix-Induced Chondrogenesis (AMIC®) is effective and safe, with significant improvements in clinical outcomes maintained from 1 to 2 years post-operation.

MRI assessments indicated satisfactory defect filling in most patients, and no treatment-related adverse events were reported, supporting the use of AMIC® as a valid option for cartilage repair in the knee.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized, Controlled Trial Comparing Autologous Matrix-Induced Chondrogenesis (AMIC®) to Microfracture: Analysis of 1- and 2-Year Follow-Up Data of 2 Centers. Anders, S., Volz, M., Frick, H., et al.[2022]

Microfracture, combined with a cell-free cartilage implant (chondrotissue), was used to treat a post-traumatic cartilage defect in a 26-year-old male, showing promising clinical and histological results after 18 months to 2 years.

This approach highlights the potential of using microfracture along with innovative materials like polyglycolic acid and hyaluronic acid to enhance cartilage repair in traumatic injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repair of a post-traumatic cartilage defect with a cell-free polymer-based cartilage implant: a follow-up at two years by MRI and histological review. Patrascu, JM., Freymann, U., Kaps, C., et al.[2012]

In a study of 10 children who underwent microfracture surgery for knee cartilage defects, the average postoperative Lysholm score was 92.1, indicating good functional outcomes, and the Tegner activity score was 7.0, suggesting a high level of physical activity post-surgery.

The results suggest that arthroscopic microfracture is a reasonable surgical option for treating knee cartilage defects in children and adolescents, but further research with larger groups and long-term follow-up is necessary to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microfracture for treatment of knee cartilage defects in children and adolescents. Salzmann, GM., Sah, BR., Schmal, H., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04537013

NCT04537013 | Clinical Study of Chondro-Gide® for Large ... Improvement in the Pain sub-scale of the Knee Injury and Osteoarthritis Outcomes Score (KOOS) between baseline to 24 months follow-up · Improvement in function, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8808829/

Systematic Review and Meta-Analysis of the Clinical ... Knee function consistently improved in the first 24 months; however only 67% to 85% of patients continued to report improved outcomes between 2 and 5 years ...

3. geistlich.com geistlich.com/fileadmin/content/International_Pharma/PDF/Orthopedic/AMIC_Chondro-Gide_in_the_Knee_-_More_than_10_Years_of_C.pdf

AMIC® Chondro-Gide® in the Knee Backed by more than 10 years of clinical success, AMIC. Chondro-Gide is an effective and cost-effective2,3 treatment for repairing cartilage lesions, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11291581/

10-year follow-up The AMIC procedure results in improved patient outcomes in comparison with microfracture up to 10 years following surgery for the repair of focal chondral ...

5. withpower.com withpower.com/trial/phase-cartilage-diseases-7-2020-e3bfc

Chondro-Gide® for Knee Cartilage Injury (SECURE Trial) Microfracture surgery for knee cartilage repair led to significant functional improvement in 67% of patients after at least two years, with better outcomes ...

6. geistlich.com geistlich.com/orthopedic/cartilage-regeneration/amic-chondro-gide

AMIC Chondro-Gide AMIC Chondro-Gide is a minimally-invasive 1-step procedure that can be performed either by mini-open surgery, or in an arthroscopic manner.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02993510?id=NCT01076673%20OR%20NCT00414700%20OR%20NCT02430558%20OR%20NCT00719576%20OR%20NCT01225575%20OR%20NCT03334812%20OR%20NCT02993510&viewType=Table&rank=3

A Randomized Controlled Trial Comparing Chondro-Gide ... The purpose of this study is to evaluate the safety and effectiveness of using Chondro-Gide® collagen membrane either sutured or glued compared to microfracture ...