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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age15-50
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

BMI> 30 kg / m2

Systemic inflammatory diseases

Inflammatory arthritis

Advanced osteoarthritis

Trial population

Specialized care

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Fresh osteochondral allografting

    Procedure/Surgery

    Transplantation of a fresh osteochondral allograft in the knee

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Fresh osteochondral allografting1 intervention

Trial outcomes

Primary outcomes

1

International Knee Documentation Committee (IKDC) Score

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).

Time frame
15 months
2

Kujala Score

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.

Time frame
15 months
3

Western Ontario Meniscal Evaluation Tool (WOMET)

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.

Time frame
15 months
4

Tegner Activity Scale

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.

Time frame
15 months

Secondary outcomes

1

Age

Years

Time frame
15 months
2

Sex at birth

Man or female

Time frame
baseline
3

IMC

kg/m\^2

Time frame
baseline
4

Concomitant procedures

Concomitant procedures (osteotomy, ligamentous repair/reconstruction, meniscal allograft transplantation) are recorded at the time of surgery.

Time frame
At the surgery

Other outcomes

Sponsors and contacts

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