Chondro-Gide® for Knee Cartilage Injury

(SECURE Trial)

Recruiting in Palo Alto (17 mi)

+20 other locations

Overseen by Kevin Plancher, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Geistlich Pharma AG

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

Disqualifiers: Obesity, Osteoarthritis, Autoimmune, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial uses a special surgery combined with a protective membrane to treat large knee cartilage damage. It aims to help patients who might not benefit as much from the surgery alone. The treatment encourages new cartilage growth and protects it with the membrane.

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 data supports the effectiveness of the treatment Chondro-Gide® for knee cartilage injury?

A study comparing the combination of microfracture with Chondro-Gide® (AMIC®) to microfracture alone showed improvements in clinical outcomes at 1 and 2 years after surgery, with satisfactory defect filling in most patients. This suggests that enhancing microfracture with Chondro-Gide® is a valid and safe option for repairing small- to medium-sized cartilage defects in the knee. ^{1 2 3 4 5}

Is Chondro-Gide® safe for treating knee cartilage injuries?

In a study comparing Chondro-Gide® combined with microfracture to microfracture alone for knee cartilage repair, no treatment-related adverse events were reported, suggesting it is generally safe for small- to medium-sized cartilage defects. ^{1 2 3 4 6}

How does the Chondro-Gide® treatment for knee cartilage injury differ from other treatments?

Chondro-Gide® enhances the microfracture technique by using a collagen matrix to treat small- to medium-sized cartilage defects, which helps improve the repair process and maintain clinical outcomes over time. This combination, known as Autologous Matrix-Induced Chondrogenesis (AMIC®), is unique because it extends the applicability of microfracture to larger defects and provides a more consistent defect filling compared to microfracture alone. ^{1 2 3 4 6}

Research Team

Kevin Plancher, MD

Principal Investigator

Plancher Orthopedics and Sports Medicine

Despoina Natsiou Schmiady, PhD

Principal Investigator

Geistlich Pharma AG

Eligibility Criteria

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 between 18 and 55 years old.

Exclusion Criteria

You are allergic to porcine collagen.

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

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

Trial Timeline

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

Treatment Details

Interventions

• Chondro-Gide® ACC (Biomaterial)
• Microfracture (Procedure)

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.

Participant Groups

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 Canada for the following indications:

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+

Findings from Research

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The microfracture technique for the treatment of articular cartilage lesions in the knee. A prospective cohort study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Chondral resurfacing of articular cartilage defects in the knee with the microfracture technique. Surgical technique. [2022]

3. United Arab Emirates 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. [2022]

4. United States 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. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Microfracture for treatment of knee cartilage defects in children and adolescents. [2021]

6. England 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. [2012]