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

200 Participants Needed

Trial Summary

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.

What data supports the idea that Osteochondral Allograft for Arthritis is an effective treatment?

The available research shows that Osteochondral Allograft (OCA) transplantation is an effective treatment for knee issues, particularly for chondral and osteochondral defects. One study highlights that OCA is a useful option for treating these defects in the knee, suggesting it can restore function by transferring healthy tissue to damaged areas. Another study indicates that OCA is often used when other treatments have failed, implying its effectiveness as a backup option. However, the research also notes that while OCA can be beneficial, it may have a higher failure rate in the ankle, especially in young patients, and sometimes requires additional procedures. ^{1 2 3 4 5}

What safety data is available for osteochondral allograft transplantation?

Osteochondral allograft transplantation (OCA) is generally considered a safe and effective treatment for large, full-thickness cartilage defects in the knee. Studies indicate satisfactory clinical outcomes and a reasonable rate of return to play among athletes. Factors such as young age and prior bony realignment procedures may decrease the risk of failure. However, variability in outcomes and graft survival rates has been noted, and OCA is often used as a salvage procedure after other treatments have failed. ^{2 3 5 6 7}

Is Osteochondral Allograft a promising treatment for arthritis?

Yes, Osteochondral Allograft is a promising treatment for arthritis. It is effective for repairing knee cartilage damage, helping patients regain function and even allowing athletes to return to play. ^{3 4 6 8 9}

What is the purpose of this trial?

This is a study comparing the current standard of care surgical treatment to a newer surgical procedure involving the implantation of osteochondral allograft at the base of the thumb. Patients will be followed at 1, 3, 6 months and 1 year post-operatively.

Research Team

Melvin P Rosenwasser, MD

Principal Investigator

Columbia University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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 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]

References

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

Long-term Follow-up of Revision Osteochondral Allograft Transplantation of the Ankle. [2019]

2. United States 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Comparison of clinical outcomes following osteochondral allograft transplantation for osteochondral versus chondral defects in the knee. [2022]

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

Fresh osteochondral allograft transplantation for bipolar reciprocal osteochondral lesions of the knee. [2022]

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

Fresh osteochondral allografts in the knee: comparison of primary transplantation versus transplantation after failure of previous subchondral marrow stimulation. [2022]

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

Return to Play Among Elite Basketball Players After Osteochondral Allograft Transplantation of Full-Thickness Cartilage Lesions. [2022]

7. United States 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. [2023]

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

Osteochondral Allograft Transplantation of the Femoral Trochlea. [2022]

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

Outcomes of Total Knee Arthroplasty After Osteochondral Allograft Transplantation. [2020]