Osteochondral Allografts for Knee Defects

Recruiting at 5 trial locations

Overseen By Nicole Litton, BS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: AlloSource

Must not be taking: Corticosteroids, Hyaluronic acid

Disqualifiers: Obesity, Cancer, Infections, others

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

Compensation: Varies

Number of Visits: 9

Duration: Immediate procedure

68 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to obtain evidence of the effectiveness of Cryopreserved Osteochondral Allograft Core in the treatment of osteochondral lesions on the femoral condyle.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are currently using oral corticosteroids or have received certain injections recently, you may not be eligible to participate.

What data supports the effectiveness of the treatment Cryopreserved Osteochondral Allograft Cores for knee defects?

Cryopreserved osteochondral allografts have shown promising results in treating full-thickness cartilage defects in the knee, with encouraging laboratory data and potential for effective tissue banking. Although fresh grafts have shown the greatest success, cryopreserved grafts are gaining interest due to their availability and potential benefits. ^{1 2 3 4 5}

Is the use of osteochondral allografts for knee defects safe?

Osteochondral allografts, including fresh and cryopreserved types, have been used safely in humans for knee defects. Fresh allografts have shown good long-term safety, with high survival rates over 5, 10, and 20 years. Cryopreserved grafts are being studied for their potential benefits, but more research is needed to fully understand their safety. ^{1 6 7 8 9}

How is the treatment of cryopreserved osteochondral allograft cores for knee defects different from other treatments?

Cryopreserved osteochondral allograft cores are unique because they allow for the preservation and storage of donor tissue, which can be used when fresh grafts are not available, reducing wait times for surgery. This treatment is particularly beneficial for patients with full-thickness cartilage defects in the knee, offering a potential solution when other cartilage repair methods have failed or are not suitable. ^{1 2 3 4 9}

Eligibility Criteria

This trial is for people aged 12-60 with moderate to severe knee pain due to cartilage damage on the femoral condyle, unresponsive to other treatments. Candidates must have stable knees or be able to stabilize them during surgery and intact menisci or correctable malalignment.

Inclusion Criteria

My knee pain is severe and hasn't improved with medication, therapy, or surgery.

My knee's cushioning is mostly intact or slightly trimmed but stable.

My knee alignment is normal or will be corrected to less than 5° off.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one or more cryopreserved osteochondral allograft core transplants to replace damaged cartilage

Immediate procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

8 visits (in-person) at 6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months

Treatment Details

Interventions

• Cryopreserved Osteochondral Allograft Cores

Trial Overview The study tests the effectiveness of Cryopreserved Osteochondral Allograft Cores in treating osteochondral lesions on the femoral condyle by transplanting these cores into patients' knees.

Participant Groups

Group I: Osteochondral transplant on the femoral condyle Experimental Treatment 1 Intervention

Eligible and enrolled patients will receive one or more cryopreserved osteochondral allograft core as part of their osteochondral transplant procedure

Who Is Running the Clinical Trial?

AlloSource

Lead Sponsor

Trials

10

Recruited

700+

Findings from Research

Osteochondral allografts, especially fresh ones, have shown promising results in treating full-thickness cartilage defects in the knee, indicating their efficacy in clinical settings.

There is increasing interest in using cryopreserved grafts due to their potential for better tissue banking and the ability to overcome delays in obtaining fresh grafts, supported by encouraging laboratory data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteochondral allografts in the treatment of articular cartilage injuries of the knee. Hennig, A., Abate, J.[2018]

In a study of 19 patients with full-thickness cartilage defects in the knee, treatment with cryopreserved osteochondral allografts led to significant improvements in knee function and quality of life, as shown by increases in various clinical outcome scores over an average follow-up of 41.9 months.

Despite positive outcomes, the study reported a reoperation rate of 21.1%, indicating that while the treatment can be effective, there is a notable risk of complications, particularly in patients with more complex (bipolar) cartilage lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Outcomes of Cryopreserved Osteochondral Allograft for Patellofemoral Cartilage Defects at Minimum 2-Year Follow-up. Melugin, HP., Ridley, TJ., Bernard, CD., et al.[2022]

Fresh osteochondral allografts have shown over 75% clinical success in treating various knee joint issues, including trauma and chondral injuries, making them a reliable option for patients.

These allografts are particularly beneficial for younger, active individuals who may not be suitable candidates for joint replacement surgery, and ongoing improvements in the procedure and understanding of their biology are expected to enhance outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fresh osteochondral allografts. Bugbee, WD.[2022]

Fresh osteochondral allograft (OCA) transplantation is an effective single-stage procedure for treating knee cartilage defects, showing reliable long-term improvements in patient outcomes and graft survival.

Using fresh precut OCA cores for smaller lesions allows for quicker treatment without the complications of donor site morbidity, making it a practical alternative to traditional grafting methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fresh Precut Osteochondral Allograft Core Transplantation for the Treatment of Femoral Cartilage Defects. Jones, KJ., Mosich, GM., Williams, RJ.[2020]

Fresh osteochondral allografts for treating larger lesions (>2.5-cm2) show good durability, with 88% of patients returning to sports and over 75% having a 10-year survival rate.

The effectiveness of these allografts is significantly affected by chondrocyte viability and density, which decline during preservation, leading to higher failure rates when the tissue is acellular.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial Commentary: The Acellular Osteochondral Allograft, the Emperor Has New Clothes. Mandelbaum, BR., Chahla, J.[2019]

The novel cryopreserved viable osteochondral allograft (CVOCA) retains viable chondrocytes and essential growth factors, which are crucial for cartilage repair, and shows improved outcomes in a goat model when combined with marrow stimulation.

Histological analysis confirmed that the CVOCA preserves the architecture of native hyaline cartilage, enhancing mesenchymal stem cell migration and chondrogenesis, leading to better cartilage repair compared to marrow stimulation alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel, cryopreserved, viable osteochondral allograft designed to augment marrow stimulation for articular cartilage repair. Geraghty, S., Kuang, JQ., Yoo, D., et al.[2018]

In a study involving 36 adult sheep, different cryopreservation methods for osteochondral allografts showed no significant differences in cartilage integration after 6 months, indicating that the methods tested may not be effective.

The results suggest that the cryopreservation protocols used in this study do not support successful integration of osteochondral allografts in clinical practice, leading to a recommendation against their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scanty integration of osteochondral allografts cryopreserved at low temperatures with dimethyl sulfoxide. Forriol, F., Longo, UG., Alvarez, E., et al.[2021]

In a study of 19 patients treated with fresh osteochondral allografts for knee defects, significant improvements in functional outcomes were observed, with scores on the Activities of Daily Living Scale and Short Form-36 increasing notably after an average follow-up of 48 months.

The study found that fresh allografts stored for 17 to 42 days were effective in maintaining cartilage structure and function, with most grafts showing preserved cartilage thickness and positive correlations between graft incorporation and functional scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fresh stored allografts for the treatment of osteochondral defects of the knee. Williams, RJ., Ranawat, AS., Potter, HG., et al.[2022]

Fresh osteochondral allografts, harvested within 24 hours of donor death and preserved for up to 4 days, maintain 100% viability of cartilage and provide a strong structural support for knee defect repairs, making them suitable for younger, active patients.

Long-term survival rates for these allografts are promising, with 95% survival at 5 years, 71% at 10 years, and 66% at 20 years, although factors like patient age and specific conditions can negatively impact outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term clinical experience with fresh osteochondral allografts for articular knee defects in high demand patients. Shasha, N., Aubin, PP., Cheah, HK., et al.[2022]

References

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

Osteochondral allografts in the treatment of articular cartilage injuries of the knee. [2018]

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

Prospective Outcomes of Cryopreserved Osteochondral Allograft for Patellofemoral Cartilage Defects at Minimum 2-Year Follow-up. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Fresh osteochondral allografts. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Fresh Precut Osteochondral Allograft Core Transplantation for the Treatment of Femoral Cartilage Defects. [2020]

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

Editorial Commentary: The Acellular Osteochondral Allograft, the Emperor Has New Clothes. [2019]

6. England pubmed.ncbi.nlm.nih.gov

A novel, cryopreserved, viable osteochondral allograft designed to augment marrow stimulation for articular cartilage repair. [2018]

7. Germany pubmed.ncbi.nlm.nih.gov

Scanty integration of osteochondral allografts cryopreserved at low temperatures with dimethyl sulfoxide. [2021]

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

Fresh stored allografts for the treatment of osteochondral defects of the knee. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Long-term clinical experience with fresh osteochondral allografts for articular knee defects in high demand patients. [2022]