Study Protocol to Evaluate Clinical and Imaging Results of Knee Fresh Osteochondral Allografts
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|ClinicalTrials.gov Identifier: NCT04236492|
Recruitment Status : Recruiting
First Posted : January 22, 2020
Last Update Posted : February 11, 2021
|Condition or disease||Intervention/treatment|
|Osteochondral Defect||Procedure: Fresh osteochondral allografting|
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.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|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|
|Actual Study Start Date :||June 6, 2018|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||June 2021|
Fresh osteochondral allografting
Transplantation of a fresh osteochondral allograft in the knee
Procedure: Fresh osteochondral allografting
Transplantation of a fresh osteochondral allograft in the knee
- International Knee Documentation Committee (IKDC) Score [ Time Frame: 15 months ]The IKDC is a patient-completed tool, which contains three domains divided on 18 (7 items for symptoms, 1 item for sport participation, 9 items for daily activities, and 1 item for current knee function). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
- Kujala Score [ Time Frame: 15 months ]The Kujala score is a 13-item questionnaire for the patient-reported assessment of anterior knee pain. The Kujala score asks about the ability to do several activities (squatting, stair climbing, running) and also the presence of symptoms/disabilities as noticed by the patient (limping, thigh atrophy, swelling, etc.). The items are summed up to give a total score ranging from 0 to 100, with high scores indicating good outcome.
- Western Ontario Meniscal Evaluation Tool (WOMET) [ Time Frame: 15 months ]WOMET is a disease-specific health-related quality of life questionnaire to measure physical symptoms, sports/reaction/work/lifestyle, and emotions of patients with meniscal pathology. It has 16 items representing the domains of physical symptoms (nine items), sports/recreation/work/lifestyle (four items), and emotions (three items). Lower scores indicate better outcome.
- Tegner Activity Scale [ Time Frame: 15 months ]Tegner activity level scale is a scale that aims to provide a standardized method of grading work and sporting activities. The patient selects the level of participation that best describes their current level of activity. A score of 0 represents "sick leave or disability pension because of knee problems," whereas a score of 10 corresponds to participation in national and international elite competitive sports. Activity levels 6-10 can only be achieved if the person participates in recreational or competitive sport.
- Patient satisfaction [ Time Frame: 15 months ]Patient satisfaction was captured using a 4-item categorical scale, with responses including extremely satisfied (4), satisfied (3), somewhat dissatisfied (2) and dissatisfied (1).
- OCAMRISS [ Time Frame: 15 months ]MRI will be performed at 9 and 15 months postoperatively. All MRI scans will be assessed by a musculoskeletal radiologist blinded to the patient's medical history and treatment using the OCAMRISS.
- Bone integration [ Time Frame: 15 months ]CT will be performed at 1 day postoperatively and at 3 months postoperatively, 6 months postoperatively and 12 months postoperatively. All CT scans will be assessed by a musculoskeletal radiologist blinded to the patient's medical history and treatment evaluating the subchondral bone and osseous integration. Collimation will be done in all CT to increase image quality and reduce the patient's overall radiation exposure.
- Age [ Time Frame: 15 months ]Years
- Sex at birth [ Time Frame: baseline ]Man or female
- IMC [ Time Frame: baseline ]kg/m^2
- Concomitant procedures [ Time Frame: At the surgery ]Concomitant procedures (osteotomy, ligamentous repair/reconstruction, meniscal allograft transplantation) are recorded at the time of surgery.
- Osteochondral allograft type [ Time Frame: At the surgery ]Patellar, femoral or tibial
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04236492
|Contact: Àlex Grau Blanesfirstname.lastname@example.org|
|Contact: Aránzazu González-Osunaemail@example.com|
|Hospital de la Santa Creu i Sant Pau||Recruiting|
|Barcelona, Catalunya, Spain, 08026|
|Sub-Investigator: Aránzazu González-Osuna|
|Sub-Investigator: Eduard Ramírez Bermejo|
|Sub-Investigator: Àlex Grau Blanes|
|Principal Investigator:||Pablo Gelber||Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau|