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

Condition(s) studied

Investigational drug(s) / intervention(s)

Fresh osteochondral allografting: Transplantation of a fresh osteochondral allograft in the knee

Study 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.

Eligibility

Primary outcome measure(s)

• 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).
• 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.
• 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.
• 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).
• 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.
• 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.

Trial sites (1)

More Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau trials in Spain