Study Protocol to Evaluate Clinical and Imaging Results of Knee Fresh Osteochondral Allografts
- Conditions
- Osteochondral Defect
- Interventions
- Procedure: Fresh osteochondral allografting
- Registration Number
- NCT04236492
- Lead Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Brief Summary
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Fresh osteochondral allografting Fresh osteochondral allografting Transplantation of a fresh osteochondral allograft in the knee
- Primary Outcome Measures
Name Time Method International Knee Documentation Committee (IKDC) Score 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).
Western Ontario Meniscal Evaluation Tool (WOMET) 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.
Bone integration 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.
Kujala Score 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.
OCAMRISS 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.
Tegner Activity Scale 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 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).
- Secondary Outcome Measures
Name Time Method Age 15 months Years
Concomitant procedures At the surgery Concomitant procedures (osteotomy, ligamentous repair/reconstruction, meniscal allograft transplantation) are recorded at the time of surgery.
Osteochondral allograft type At the surgery Patellar, femoral or tibial
Sex at birth baseline Man or female
IMC baseline kg/m\^2
Trial Locations
- Locations (1)
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Catalunya, Spain