Study Protocol to Evaluate Clinical and Imaging Results of Knee Fresh Osteochondral Allografts

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status: Enrolling

Conditions: Osteochondral Defect

Treatments: Procedure: Fresh osteochondral allografting

Study type: Observational

Funder types: Other

Identifiers

NCT04236492

IIBSP-ALO-2018-21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 15 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

40 participants in 1 patient group

Fresh osteochondral allografting

Description:

Transplantation of a fresh osteochondral allograft in the knee

Treatment:

Procedure: Fresh osteochondral allografting