Study Protocol to Evaluate Clinical and Imaging Results of Knee Fresh Osteochondral Allografts
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fresh osteochondral allografting.
- Who it may be relevant to
- Registry conditions: Osteochondral Defect. Basic parameters: 15 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Study Protocol for a Prospective Observational Study to Evaluate the Clinical and Imaging Results of the Fresh Osteochondral Allograft Transplantation for Osteochondral Knee Lesions
Overview
The main objective of this study is to assess the clinical and radiological results after carrying out a transplant of fresh osteochondral allograft in the knee.
Detailed description
Fresh osteochondral allograft transplantation allows treatment of large osteochondral lesions of the knee in young patients. Real-world, patient-centered data on clinical and imaging results after fresh osteochondral allograft transplantation are needed.
This study is a prospective, observational, unicenter, patient-centered outcomes research study. Patients undergoing cartilage repair with fresh osteochondral allograft transplantation for osteochondral knee lesions are eligible to participate.
Clinical results are evaluated from baseline to 3 months, 6 months, 9 months, 12 months and 15 months postoperatively. At each time point, participants respond to several patient-reported outcome instruments to measure clinical results (IKDC, Kujala, Womet and Tegner) and patient satisfaction is captured.
Imaging results are evaluated with MRI (9 months and 15 months postoperatively) using the OCAMRISS evaluating cartilage features, bone features and ancillary features; and with CT (1 day, 3 months, 6 months and 12 months postoperatively) evaluating subchondral bone and osseous integration.
Variations will be explored using additional or alternative covariates such as concomitant surgery procedures, osteochondral allograft morphology, age, sex at birth, IMC, living situation and employment status.
Interventions
- Procedure Fresh osteochondral allografting
Transplantation of a fresh osteochondral allograft in the knee
Primary outcome measures
- International Knee Documentation Committee (IKDC) Score [Time frame: 15 months]
- Kujala Score [Time frame: 15 months]
- Western Ontario Meniscal Evaluation Tool (WOMET) [Time frame: 15 months]
- Tegner Activity Scale [Time frame: 15 months]
- Patient satisfaction [Time frame: 15 months]
- OCAMRISS [Time frame: 15 months]
- Bone integration [Time frame: 15 months]
Secondary outcome measures (5)
- Age [Time frame: 15 months]
- Sex at birth [Time frame: baseline]
- IMC [Time frame: baseline]
- Concomitant procedures [Time frame: At the surgery]
- Osteochondral allograft type [Time frame: At the surgery]
Eligibility criteria
Inclusion criteria
Patients undergoing cartilage repair with fresh osteochondral allograft transplantation for large focal full-thickness chondral and osteochondral defects (>2 cm2) on the tibial plateau, femoral condyles, trochlea and/or patella Bipolar lesions are included.
Exclusion criteria
- BMI> 30 kg / m2
- Systemic inflammatory diseases
- Inflammatory arthritis
- Advanced osteoarthritis
- Tricompartmental degenerative process
- Active infection
- Patients who are unable to provide written informed consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- Hospital de la Santa Creu i Sant Pau — Barcelona
Publications
- Flanigan DC, Harris JD, Trinh TQ, Siston RA, Brophy RH. Prevalence of chondral defects in athletes' knees: a systematic review. Med Sci Sports Exerc. 2010 Oct;42(10):1795-801. doi: 10.1249/MSS.0b013e3181d9eea0. PMID 20216470
- Mankin HJ. The response of articular cartilage to mechanical injury. J Bone Joint Surg Am. 1982 Mar;64(3):460-6. No abstract available. PMID 6174527
- Sherman SL, Garrity J, Bauer K, Cook J, Stannard J, Bugbee W. Fresh osteochondral allograft transplantation for the knee: current concepts. J Am Acad Orthop Surg. 2014 Feb;22(2):121-33. doi: 10.5435/JAAOS-22-02-121. PMID 24486758
- Widuchowski W, Widuchowski J, Trzaska T. Articular cartilage defects: study of 25,124 knee arthroscopies. Knee. 2007 Jun;14(3):177-82. doi: 10.1016/j.knee.2007.02.001. Epub 2007 Apr 10. PMID 17428666
- Bugbee WD, Convery FR. Osteochondral allograft transplantation. Clin Sports Med. 1999 Jan;18(1):67-75. doi: 10.1016/s0278-5919(05)70130-7. PMID 10028117
- Oakeshott RD, Farine I, Pritzker KP, Langer F, Gross AE. A clinical and histologic analysis of failed fresh osteochondral allografts. Clin Orthop Relat Res. 1988 Aug;(233):283-94. PMID 3042234
- Czitrom AA, Keating S, Gross AE. The viability of articular cartilage in fresh osteochondral allografts after clinical transplantation. J Bone Joint Surg Am. 1990 Apr;72(4):574-81. PMID 2324145
- Maury AC, Safir O, Heras FL, Pritzker KP, Gross AE. Twenty-five-year chondrocyte viability in fresh osteochondral allograft. A case report. J Bone Joint Surg Am. 2007 Jan;89(1):159-65. doi: 10.2106/JBJS.E.00815. No abstract available. PMID 17200323
Identifiers
NCT: NCT04236492 · IIBSP-ALO-2018-21