Trial Summary
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.
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.
12345What 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.
23567Eligibility 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 18 years old or older.
I am recommended surgery for thumb arthritis.
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Columbia University Irving Medical CenterNew York, NY
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Who Is Running the Clinical Trial?
Columbia UniversityLead Sponsor
References
Long-term Follow-up of Revision Osteochondral Allograft Transplantation of the Ankle. [2019]Osteochondral allograft (OCA) transplantation is a useful alternative for treatment of posttraumatic ankle arthritis in young patients but has a relatively high failure rate and further procedures are often required. The purpose of this study was to evaluate outcomes of patients who underwent revision OCA transplantation of the ankle after failed primary OCA transplantation.
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]Osteochondral allograft (OCA) transplantation is a restorative surgical option for large, full-thickness chondral or osteochondral defects in the knee. Variability in outcomes reporting has led to a broad range of graft survival rates. Using rate of salvage surgery following OCA as a failure metric, the purpose of this study was to analyze the incidence and risk factors for failure in a nationwide cohort.
Comparison of clinical outcomes following osteochondral allograft transplantation for osteochondral versus chondral defects in the knee. [2022]Osteochondral allograft (OCA) transplantation is a restorative technique for addressing articular cartilage defects by transferring mature viable chondrocytes with subchondral bone into size-matched lesions. The purpose of this study was to compare differences in clinical and functional outcomes in patients treated with OCA for osteochondral defects compared with isolated chondral pathology.
Fresh osteochondral allograft transplantation for bipolar reciprocal osteochondral lesions of the knee. [2022]Osteochondral allograft (OCA) transplantation is an effective treatment option for chondral and osteochondral defects of the knee.
Fresh osteochondral allografts in the knee: comparison of primary transplantation versus transplantation after failure of previous subchondral marrow stimulation. [2022]In most treatment algorithms, osteochondral allograft (OCA) transplantation is regarded as an alternative salvage procedure when other, previous reparative treatments have failed.
Return to Play Among Elite Basketball Players After Osteochondral Allograft Transplantation of Full-Thickness Cartilage Lesions. [2022]Osteochondral allograft transplantation (OCA) is a recognized option for full-thickness articular cartilage defects of the knee, especially in the setting of large lesions or those involving the subchondral bone. Previous heterogenous studies of athletes have shown a 75% to 79% rate of return to play after the procedure.
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 (OCA) treats symptomatic focal cartilage defects with satisfactory clinical results.
Osteochondral Allograft Transplantation of the Femoral Trochlea. [2022]Osteochondral allograft (OCA) transplantation is a recognized treatment modality for cartilage damage in the knee. Few reports are available on outcomes of OCA in the patellofemoral joint, and there are no reports on lesions isolated to the femoral trochlea.
Outcomes of Total Knee Arthroplasty After Osteochondral Allograft Transplantation. [2020]Fresh osteochondral allograft (OCA) transplantation is an effective treatment for osteochondral defects. Some patients require further surgical intervention, such as total knee arthroplasty (TKA). The effects of prior OCA transplantation on TKA outcomes are unknown.