Clinical trial NCT04236492: Study Protocol to Evaluate Clinical and Imaging Results of Knee Fresh Osteochondral Allografts
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteochondral Defect
Keywords: fresh osteochondral allografts
integration
osteochondral defect
knee
chondral lesion
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Banc de Sang i Teixits
First posted: 2020-01-22
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Specialized care

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.

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.

Primary outcomes:
measure: International Knee Documentation Committee (IKDC) Score
timeFrame: 15 months
measure: Kujala Score
timeFrame: 15 months
measure: Western Ontario Meniscal Evaluation Tool (WOMET)
timeFrame: 15 months
measure: Tegner Activity Scale
timeFrame: 15 months
measure: Patient satisfaction
timeFrame: 15 months
measure: OCAMRISS
timeFrame: 15 months
measure: Bone integration
timeFrame: 15 months
Secondary outcomes:
measure: Age
timeFrame: 15 months
measure: Sex at birth
timeFrame: baseline
measure: IMC
timeFrame: baseline
measure: Concomitant procedures
timeFrame: At the surgery
measure: Osteochondral allograft type
timeFrame: At the surgery
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Catalunya
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Pablo Gelber
role: PRINCIPAL_INVESTIGATOR
References:
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