200 Participants Needed

Osteochondral Allograft for Arthritis

SS
MP
Overseen ByMelvin P Rosenwasser, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Columbia University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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.12345

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.23567

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.34689

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

MP

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
2Treatment groups
Experimental Treatment
Active Control
Group I: Osteochondral AllograftExperimental Treatment1 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 Control1 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

Find a Clinic Near You

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.
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.
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.
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]

References

Long-term Follow-up of Revision Osteochondral Allograft Transplantation of the Ankle. [2019]
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]
Comparison of clinical outcomes following osteochondral allograft transplantation for osteochondral versus chondral defects in the knee. [2022]
Fresh osteochondral allograft transplantation for bipolar reciprocal osteochondral lesions of the knee. [2022]
Fresh osteochondral allografts in the knee: comparison of primary transplantation versus transplantation after failure of previous subchondral marrow stimulation. [2022]
Return to Play Among Elite Basketball Players After Osteochondral Allograft Transplantation of Full-Thickness Cartilage Lesions. [2022]
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]
Osteochondral Allograft Transplantation of the Femoral Trochlea. [2022]
Outcomes of Total Knee Arthroplasty After Osteochondral Allograft Transplantation. [2020]
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