Osteochondral Allograft for Arthritis

Overseen By Melvin P Rosenwasser, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Pregnancy, Prisoners, Previous surgery, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new surgical method for treating arthritis at the base of the thumb. Researchers compare the usual surgery, Ligament Reconstruction Tendon Interposition (LRTI), which involves moving a tendon to support the thumb, with a new approach called Osteochondral Allograft. This new method uses a bone graft from a donor to replace the damaged bone. The goal is to determine if the new method provides better long-term results. Individuals diagnosed with arthritis at the thumb base and considering surgery might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to explore innovative surgical options that could improve quality of life.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that osteochondral allograft transplantation is generally safe and effective for treating cartilage problems. Studies have found that it produces good results. For instance, one study discovered that patients who started walking immediately after surgery did just as well as those who delayed weight-bearing, indicating the procedure is well-tolerated.

Another study focused on individuals who underwent this procedure for knee issues and found positive long-term results, meaning they did well for an extended period after surgery. Reports also support the safety of osteochondral allografts and highlight their use in treating joint problems like osteonecrosis, a condition where bone tissue dies.

Overall, these findings suggest that osteochondral allografts are a safe option for treating joint issues. While every surgery carries some risks, current research supports that this treatment is generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatment for thumb arthritis, which often involves Ligament Reconstruction Tendon Interposition (LRTI), the new osteochondral allograft treatment uses a unique approach. This involves replacing the arthritic trapezium bone with a femoral trochlear osteochondral allograft, known as 'Cartibend©', which closely mimics the natural shape and surface of the human trapezium. Researchers are excited because this innovative method could offer a more natural joint reconstruction, potentially improving joint function and reducing recovery time compared to traditional LRTI procedures.

What evidence suggests that this trial's treatments could be effective for arthritis?

Research has shown that using donor tissue to replace damaged joint surfaces, known as osteochondral allografts, succeeds, especially in knee surgeries. Studies indicate that 89% of these grafts last at least five years without major problems, meaning most transplants work well for this duration. Patients often experience good to excellent results, particularly for single joint issues. While most research focuses on knees, these positive outcomes suggest potential benefits for other joints, like the thumb. In this trial, one group of participants will receive the Osteochondral Allograft procedure to assess its effectiveness for thumb arthritis. ^{1 3 6 7 8}

Who Is on the Research Team?

Melvin P Rosenwasser, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need surgery to manage basal joint arthritis, which affects the base of the thumb. Participants must be suitable candidates for surgical intervention.

Inclusion Criteria

I am recommended surgery for thumb arthritis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Treatment

Participants undergo either Ligament Reconstruction Tendon Interposition (LRTI) or Osteochondral Allograft procedure

Surgical procedure

Post-operative Follow-up

Participants are monitored at 1, 3, 6 months and 1 year post-operatively for safety and effectiveness

1 year

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Ligament Reconstruction Tendon Interposition
• Osteochondral Allograft

Trial Overview The study compares traditional ligament reconstruction and tendon interposition (LRTI) surgery with a newer procedure that uses an osteochondral allograft implant at the thumb's base. Progress is monitored up to one year after surgery.

How Is the Trial Designed?

Group I: Osteochondral Allograft Experimental Treatment 1 Intervention

Selected randomly,100 patients will receive this treatment. In this procedure, the arthritic bone that the thumb rests on (the trapezium) is removed and replaced with femoral trochlear osteochondral allograft that is designed to be similar in morphology to the human trapezium articular surface, known as the 'Cartibend©' .

Group II: Ligament Reconstruction Tendon Interposition (LRTI) Active Control 1 Intervention

Selected randomly, 100 patients will receive this treatment. During the LRTI (standard of care procedure), the arthritic bone that the thumb rests on (the trapezium) is removed. A small cut is made in the forearm to release a tendon, which is moved to the base of the thumb to fill in the area from which the trapezium bone was removed. A small suture anchor is then placed into a thumb bone which holds everything together.

Osteochondral Allograft is already approved in United States, European Union for the following indications:

Approved in United States as Osteochondral Allograft for:

• Large full-thickness chondral defects
• Osteochondritis dissecans
• Focal avascular necrosis
• Post-traumatic osteoarthritis

Approved in European Union as Osteochondral Allograft for:

• Symptomatic full-thickness osteochondral lesions larger than 3 cm
• Chondral lesions associated with diseased subchondral bone

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Published Research Related to This Trial

In a study of 11 elite collegiate and professional basketball players who underwent osteochondral allograft transplantation (OCA) for knee cartilage defects, the overall return-to-play rate was 80%, indicating that this procedure is effective for athletes.

The median time for these players to return to competition was 14 months, and there was no significant decline in performance metrics post-surgery, suggesting that OCA can maintain athletic performance levels after recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Return to Play Among Elite Basketball Players After Osteochondral Allograft Transplantation of Full-Thickness Cartilage Lesions. Balazs, GC., Wang, D., Burge, AJ., et al.[2022]

In a study comparing 46 knees undergoing primary osteochondral allograft (OCA) transplantation to 46 knees that had OCA after failed subchondral marrow stimulation, the primary group had a lower reoperation rate (24%) compared to the secondary group (44%), indicating that primary OCA may be more favorable.

Both groups showed significant improvements in pain and function after surgery, with high patient satisfaction rates (87% in the primary group and 97% in the secondary group), suggesting that OCA transplantation is effective regardless of prior treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fresh osteochondral allografts in the knee: comparison of primary transplantation versus transplantation after failure of previous subchondral marrow stimulation. Gracitelli, GC., Meric, G., Briggs, DT., et al.[2022]

Osteochondral allograft (OCA) transplantation is an effective salvage treatment for bipolar cartilage lesions in the knee, showing significant clinical improvement in patients with surviving allografts, as evidenced by improved scores in pain and function after a mean follow-up of 7 years.

Despite a 64.1% survivorship rate at 5 years and a high reoperation rate (46% of knees considered failures), the procedure resulted in meaningful improvements in knee function and pain for those whose allografts remained intact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fresh osteochondral allograft transplantation for bipolar reciprocal osteochondral lesions of the knee. Meric, G., Gracitelli, GC., Görtz, S., et al.[2022]

In a study of 29 knees from 28 patients who underwent osteochondral allograft (OCA) transplantation for femoral trochlea cartilage damage, the graft survivorship was 100% at 5 years and 91.7% at 10 years, indicating long-term effectiveness of the procedure.

Patients reported significant improvements in pain and function, with high satisfaction rates (89% satisfied or extremely satisfied), demonstrating that fresh OCA transplantation can lead to excellent clinical outcomes for this specific type of cartilage damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteochondral Allograft Transplantation of the Femoral Trochlea. Cameron, JI., Pulido, PA., McCauley, JC., et al.[2022]

In a study of 35 patients who underwent total knee arthroplasty (TKA) after fresh osteochondral allograft (OCA) transplantation, there was a notable failure rate of 31.4% after a mean follow-up of 9.2 years, indicating that prior OCA may not guarantee better outcomes for subsequent TKA.

Patients with multiple knee surgeries before TKA experienced more functional limitations and higher failure rates, suggesting that the number of prior surgeries is a significant factor influencing TKA outcomes, while OCA transplantation itself did not increase surgical complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Total Knee Arthroplasty After Osteochondral Allograft Transplantation. Steinhoff, AK., Bugbee, WD.[2020]

Patients treated with osteochondral allograft (OCA) transplantation for osteochondral defects showed significantly better functional outcomes, as measured by KOOS JR. and IKDC scores, compared to those with isolated chondral pathology, based on a study of 86 patients over an average follow-up of 5.4 years.

The rate of failure was lower in the osteochondral group (8.3%) compared to the chondral group (32.3%), suggesting that OCA is a more effective option for osteochondral defects in terms of both outcomes and durability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of clinical outcomes following osteochondral allograft transplantation for osteochondral versus chondral defects in the knee. Matthews, JR., Brutico, J., Heard, J., et al.[2022]

In a study of 6,391 patients who underwent osteochondral allograft (OCA) transplantation, the cumulative 5-year salvage surgery rate was only 1.71%, indicating that OCA is a durable option for restoring knee cartilage.

Younger patients (ages 20 to 29) and those who had prior bony realignment procedures showed significantly lower rates of needing salvage surgery, suggesting that these factors may enhance the success of OCA procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Young Age and Concomitant or Prior Bony Realignment Procedures are Associated with Decreased Risk of Failure of Osteochondral Allograft Transplantation in the Knee: A Nationwide Database Study. Byrne, RA., Albright, JA., Reiad, TA., et al.[2023]

Osteochondral allograft transplantation (OCA) has shown satisfactory long-term outcomes for treating articular cartilage defects, with 83.1% of patients reporting positive results after a mean follow-up of 54.39 months across 105 studies involving 5952 patients.

The procedure is particularly effective for knee cartilage defects, especially in young male adults with a mean age of 34.2 years, and has a relatively low failure rate of 18.8%, with high allograft survival rates at various time points up to 25 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and Clinical Outcomes After Osteochondral Allograft Transplantation for Treating Articular Cartilage Defects: Systematic Review and Single-Arm Meta-analysis of Studies From 2001 to 2020. Wang, X., Ren, Z., Liu, Y., et al.[2023]

In a study of 20 patients who underwent revision osteochondral allograft (OCA) transplantation for failed primary procedures, 30% experienced further surgical failures, indicating a significant risk of complications such as arthrodesis or amputation.

Despite a 65% graft survivorship at 10 years and an average satisfaction score of 70.5, many patients reported moderate to severe pain, highlighting the need for careful patient selection and evaluation of OCA as a revision option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Follow-up of Revision Osteochondral Allograft Transplantation of the Ankle. Gaul, F., Tírico, LEP., McCauley, JC., et al.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40671241/

A Multivariable Analysis of 560 Knees Treatment failure occurred in 89 knees (15.9%) at a median of 3.9 years postoperatively. Graft survivorship was 89% at 5 years, 83% at 10 years, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2667254525000046

Combination of osteochondral allograft transplantation and ... Rodriguez-Merchan et al completed a systematic review of OCAs for large lesions of the knee and found a survivorship of 89% at 5 years. OCA is ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02308358

Long Term Outcomes of Osteochondral Allografts for ... Clinical outcome of osteochondral autografts has been documented in various studies as good to excellent, particularly in subjects with isolated femoral lesions ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10515554/

Characteristics and Clinical Outcomes After Osteochondral ... Allograft survival rates at 2, 5, 10, 15, 20, and 25 years were 94%, 87.9%, 80%, 73%, 55%, and 59.4%, respectively. OCA was mainly performed on the knee (88.9%) ...

5. kneesurgrelatres.biomedcentral.com kneesurgrelatres.biomedcentral.com/articles/10.1186/s43019-022-00149-z

Comparison of clinical outcomes following osteochondral ... The findings of this study indicate that patients undergoing OCA for osteochondral defects may have greater functional outcomes and similar failure rates.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11363230/

Comparison of Patient-Reported Outcomes for Immediate ... Results indicated that immediate unrestricted WBAT after OCA transplantation to the distal femur was equally safe and effective compared to restricted TTWB.

7. hca.wa.gov hca.wa.gov/assets/program/oats_final_report%5B1%5D.pdf

Osteochondral Allograft/Autograft Transplantation (OAT) Summary of findings of safety outcomes for osteochondral allograft transplantation (using dowel, cylindrical press-fit plugs without ...

8. arthroscopysportsmedicineandrehabilitation.org arthroscopysportsmedicineandrehabilitation.org/article/S2666-061X(25)00077-X/fulltext

Current Techniques for Processing Osteochondral ... They are a safe and effective option for the treatment of osteochondral lesions, posttraumatic arthritis, osteonecrosis, failed fixation of osteochondritis ...