Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04236492
Recruitment Status : Recruiting
First Posted : January 22, 2020
Last Update Posted : February 11, 2021
Sponsor:
Collaborator:
Banc de Sang i Teixits
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Condition or disease Intervention/treatment
Osteochondral Defect Procedure: Fresh osteochondral allografting

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : June 6, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : June 2021

Group/Cohort Intervention/treatment
Fresh osteochondral allografting
Transplantation of a fresh osteochondral allograft in the knee
Procedure: Fresh osteochondral allografting
Transplantation of a fresh osteochondral allograft in the knee




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Specialized care
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04236492


Contacts
Layout table for location contacts
Contact: Àlex Grau Blanes +34935537031 agraub@santpau.cat
Contact: Aránzazu González-Osuna +34935537031 agonzalezo@santpau.cat

Locations
Layout table for location information
Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Catalunya, Spain, 08026
Contact    932919000      
Sub-Investigator: Aránzazu González-Osuna         
Sub-Investigator: Eduard Ramírez Bermejo         
Sub-Investigator: Àlex Grau Blanes         
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Banc de Sang i Teixits
Investigators
Layout table for investigator information
Principal Investigator: Pablo Gelber Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Publications:

Layout table for additonal information
Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT04236492    
Other Study ID Numbers: IIBSP-ALO-2018-21
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: February 11, 2021
Last Verified: February 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
fresh osteochondral allografts
integration
osteochondral defect
knee
chondral lesion
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteochondrosis
Bone Diseases
Musculoskeletal Diseases