Osteochondral DefectNCT04236492
Study Protocol to Evaluate Clinical and Imaging Results of Knee Fresh Osteochondral Allografts
An observational study of Osteochondral Defect, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Osteochondral Defect
- What is being tested?
- Fresh osteochondral allografting
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 6 Jun 2018to 10 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Specialized care
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08026
932919000
Aránzazu González-Osuna
About this study
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
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.
Read the 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.
- Conditions
- Osteochondral Defect
- Being tested
- Fresh osteochondral allografting
- Keywords
- fresh osteochondral allografts, integration, osteochondral defect, knee, chondral lesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh osteochondral allograftingProcedure or surgery
Transplantation of a fresh osteochondral allograft in the knee
| Study group | Role | What they receive |
|---|---|---|
| Fresh osteochondral allografting | Transplantation of a fresh osteochondral allograft in the knee Receives: Procedure: Fresh osteochondral allografting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 15 months
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.
Measured: 15 months
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.
Measured: 15 months
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.
Measured: 15 months
Patient satisfaction
Patient satisfaction was captured using a 4-item categorical scale, with responses including extremely satisfied (4), satisfied (3), somewhat dissatisfied (2) and dissatisfied (1).
Measured: 15 months
OCAMRISS
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.
Measured: 15 months
Bone integration
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.
Measured: 15 months
Secondary outcomes (5)
Age
Years
Measured: 15 months
Sex at birth
Man or female
Measured: baseline
IMC
kg/m^2
Measured: baseline
Concomitant procedures
Concomitant procedures (osteotomy, ligamentous repair/reconstruction, meniscal allograft transplantation) are recorded at the time of surgery.
Measured: At the surgery
Osteochondral allograft type
Patellar, femoral or tibial
Measured: At the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start6 Jun 2018
- Primary completion10 Mar 2026 (estimated)
- Study completion10 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Osteochondral DefectStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Banc de Sang i Teixits
- Responsible party
- Sponsor
- Investigators
- Pablo Gelber, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236492
- Sponsor's protocol ID
- IIBSP-ALO-2018-21
- Status last verified
- Mar 2023
- First submitted
- 31 Jul 2018
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Flanigan DC, Harris JD, Trinh TQ, Siston RA, Brophy RH. Prevalence of chondral defects in athletes' knees: a systematic review. Med Sci Sports Exerc. 2010 Oct;42(10):1795-801. doi: 10.1249/MSS.0b013e3181d9eea0.
PubMed 20216470Mankin HJ. The response of articular cartilage to mechanical injury. J Bone Joint Surg Am. 1982 Mar;64(3):460-6. No abstract available.
PubMed 6174527Sherman SL, Garrity J, Bauer K, Cook J, Stannard J, Bugbee W. Fresh osteochondral allograft transplantation for the knee: current concepts. J Am Acad Orthop Surg. 2014 Feb;22(2):121-33. doi: 10.5435/JAAOS-22-02-121.
PubMed 24486758Widuchowski W, Widuchowski J, Trzaska T. Articular cartilage defects: study of 25,124 knee arthroscopies. Knee. 2007 Jun;14(3):177-82. doi: 10.1016/j.knee.2007.02.001. Epub 2007 Apr 10.
PubMed 17428666Bugbee WD, Convery FR. Osteochondral allograft transplantation. Clin Sports Med. 1999 Jan;18(1):67-75. doi: 10.1016/s0278-5919(05)70130-7.
PubMed 10028117Oakeshott RD, Farine I, Pritzker KP, Langer F, Gross AE. A clinical and histologic analysis of failed fresh osteochondral allografts. Clin Orthop Relat Res. 1988 Aug;(233):283-94.
PubMed 3042234Czitrom AA, Keating S, Gross AE. The viability of articular cartilage in fresh osteochondral allografts after clinical transplantation. J Bone Joint Surg Am. 1990 Apr;72(4):574-81.
PubMed 2324145Maury AC, Safir O, Heras FL, Pritzker KP, Gross AE. Twenty-five-year chondrocyte viability in fresh osteochondral allograft. A case report. J Bone Joint Surg Am. 2007 Jan;89(1):159-65. doi: 10.2106/JBJS.E.00815. No abstract available.
PubMed 17200323Sirlin CB, Brossmann J, Boutin RD, Pathria MN, Convery FR, Bugbee W, Deutsch R, Lebeck LK, Resnick D. Shell osteochondral allografts of the knee: comparison of mr imaging findings and immunologic responses. Radiology. 2001 Apr;219(1):35-43. doi: 10.1148/radiology.219.1.r01ap0435.
PubMed 11274532Gross AE, Kim W, Las Heras F, Backstein D, Safir O, Pritzker KP. Fresh osteochondral allografts for posttraumatic knee defects: long-term followup. Clin Orthop Relat Res. 2008 Aug;466(8):1863-70. doi: 10.1007/s11999-008-0282-8. Epub 2008 May 9.
PubMed 18465182Torga Spak R, Teitge RA. Fresh osteochondral allografts for patellofemoral arthritis: long-term followup. Clin Orthop Relat Res. 2006 Mar;444:193-200. doi: 10.1097/01.blo.0000201152.98830.ed.
PubMed 16523140Chu CR, Convery FR, Akeson WH, Meyers M, Amiel D. Articular cartilage transplantation. Clinical results in the knee. Clin Orthop Relat Res. 1999 Mar;(360):159-68.
PubMed 10101321Jamali AA, Emmerson BC, Chung C, Convery FR, Bugbee WD. Fresh osteochondral allografts: results in the patellofemoral joint. Clin Orthop Relat Res. 2005 Aug;(437):176-85.
PubMed 16056047Locht RC, Gross AE, Langer F. Late osteochondral allograft resurfacing for tibial plateau fractures. J Bone Joint Surg Am. 1984 Mar;66(3):328-35.
PubMed 6699046Shasha N, Krywulak S, Backstein D, Pressman A, Gross AE. Long-term follow-up of fresh tibial osteochondral allografts for failed tibial plateau fractures. J Bone Joint Surg Am. 2003;85-A Suppl 2:33-9. doi: 10.2106/00004623-200300002-00005.
PubMed 12721343
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04236492
- Acronym / sponsor ID
- IIBSP-ALO-2018-21
- Conditions
- Osteochondral Defect
- Keywords
- fresh osteochondral allografts, integration, osteochondral defect, knee, chondral lesion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Banc de Sang i Teixits
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 10 Mar 2026 (estimated)
- Study completion
- 10 Nov 2026 (estimated)
- First posted
- 22 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fresh osteochondral allografting | – | Procedure: Fresh osteochondral allograftingTransplantation of a fresh osteochondral allograft in the knee |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Specialized care
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- BMI> 30 kg / m2
- Systemic inflammatory diseases
- Inflammatory arthritis
- Advanced osteoarthritis
- Tricompartmental degenerative process
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fresh osteochondral allograftingTransplantation of a fresh osteochondral allograft in the knee | Procedure or surgery | Fresh osteochondral allografting |
Primary outcome
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).
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.
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.
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.
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).
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.
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.
5 secondary outcomes
Age
Time frame: 15 months
Sex at birth
Time frame: baseline
IMC
Time frame: baseline
Concomitant procedures
Time frame: At the surgery
Osteochondral allograft type
Time frame: At the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Background: PubMed 20216470Flanigan DC, Harris JD, Trinh TQ, Siston RA, Brophy RH. Prevalence of chondral defects in athletes' knees: a systematic review. Med Sci Sports Exerc. 2010 Oct;42(10):1795-801. doi: 10.1249/MSS.0b013e3181d9eea0.
- Background: PubMed 6174527Mankin HJ. The response of articular cartilage to mechanical injury. J Bone Joint Surg Am. 1982 Mar;64(3):460-6. No abstract available.
- Background: PubMed 24486758Sherman SL, Garrity J, Bauer K, Cook J, Stannard J, Bugbee W. Fresh osteochondral allograft transplantation for the knee: current concepts. J Am Acad Orthop Surg. 2014 Feb;22(2):121-33. doi: 10.5435/JAAOS-22-02-121.
- Background: PubMed 17428666Widuchowski W, Widuchowski J, Trzaska T. Articular cartilage defects: study of 25,124 knee arthroscopies. Knee. 2007 Jun;14(3):177-82. doi: 10.1016/j.knee.2007.02.001. Epub 2007 Apr 10.
- Background: PubMed 10028117Bugbee WD, Convery FR. Osteochondral allograft transplantation. Clin Sports Med. 1999 Jan;18(1):67-75. doi: 10.1016/s0278-5919(05)70130-7.
- Background: PubMed 3042234Oakeshott RD, Farine I, Pritzker KP, Langer F, Gross AE. A clinical and histologic analysis of failed fresh osteochondral allografts. Clin Orthop Relat Res. 1988 Aug;(233):283-94.
- Background: PubMed 2324145Czitrom AA, Keating S, Gross AE. The viability of articular cartilage in fresh osteochondral allografts after clinical transplantation. J Bone Joint Surg Am. 1990 Apr;72(4):574-81.
- Background: PubMed 17200323Maury AC, Safir O, Heras FL, Pritzker KP, Gross AE. Twenty-five-year chondrocyte viability in fresh osteochondral allograft. A case report. J Bone Joint Surg Am. 2007 Jan;89(1):159-65. doi: 10.2106/JBJS.E.00815. No abstract available.
- Background: PubMed 11274532Sirlin CB, Brossmann J, Boutin RD, Pathria MN, Convery FR, Bugbee W, Deutsch R, Lebeck LK, Resnick D. Shell osteochondral allografts of the knee: comparison of mr imaging findings and immunologic responses. Radiology. 2001 Apr;219(1):35-43. doi: 10.1148/radiology.219.1.r01ap0435.
- Background: PubMed 18465182Gross AE, Kim W, Las Heras F, Backstein D, Safir O, Pritzker KP. Fresh osteochondral allografts for posttraumatic knee defects: long-term followup. Clin Orthop Relat Res. 2008 Aug;466(8):1863-70. doi: 10.1007/s11999-008-0282-8. Epub 2008 May 9.
- Background: PubMed 16523140Torga Spak R, Teitge RA. Fresh osteochondral allografts for patellofemoral arthritis: long-term followup. Clin Orthop Relat Res. 2006 Mar;444:193-200. doi: 10.1097/01.blo.0000201152.98830.ed.
- Background: PubMed 10101321Chu CR, Convery FR, Akeson WH, Meyers M, Amiel D. Articular cartilage transplantation. Clinical results in the knee. Clin Orthop Relat Res. 1999 Mar;(360):159-68.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pablo Gelber principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteochondral Defect, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Àlex Grau Blanes (+34935537031, agraub@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Knee Documentation Committee (IKDC) Score (time frame: 15 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04236492, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.