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NCT Number: NCT04236492

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

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.

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Key information

Age range

15 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08026, Spain

Location status: Recruiting

Location contact

Aránzazu González-Osuna

SUB_INVESTIGATOR

Eduard Ramírez Bermejo

SUB_INVESTIGATOR

Àlex Grau Blanes

SUB_INVESTIGATOR

CONTACT

932919000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fresh osteochondral allografting

Procedure

Transplantation of a fresh osteochondral allograft in the knee

Primary outcomes

  1. International Knee Documentation Committee (IKDC) Score

    Time frame: 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).

  2. Kujala Score

    Time frame: 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.

  3. Western Ontario Meniscal Evaluation Tool (WOMET)

    Time frame: 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.

  4. Tegner Activity Scale

    Time frame: 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.

  5. Patient satisfaction

    Time frame: 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).

  6. OCAMRISS

    Time frame: 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.

  7. Bone integration

    Time frame: 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.

Secondary outcomes

  1. Age

    Time frame: 15 months

    Years

  2. Sex at birth

    Time frame: baseline

    Man or female

  3. IMC

    Time frame: baseline

    kg/m^2

  4. Concomitant procedures

    Time frame: At the surgery

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

  5. Osteochondral allograft type

    Time frame: At the surgery

    Patellar, femoral or tibial

Study contacts

Contact information is provided by the study sponsor or research team.

Aránzazu González-Osuna

CONTACT

[email protected]

+34935537031

Àlex Grau Blanes

CONTACT

[email protected]

+34935537031

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Banc de Sang i Teixits

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2020
Registry last updated
Mar 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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