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

Osteochondral Defect Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04236492
• Other study ID #: IIBSP-ALO-2018-21
• Status: Recruiting
• Start date: June 6, 2018
• Est. completion date: November 10, 2026

Study information

• Verified date: March 2023
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Àlex Grau Blanes
• Phone: +34935537031
• Email: agraub[@]santpau.cat
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 10, 2026
• Est. primary completion date: March 10, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteochondral Defect

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona	Catalunya

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Banc de Sang i Teixits

Country where clinical trial is conducted

Spain, 

References & Publications (16)

Bugbee WD, Convery FR. Osteochondral allograft transplantation. Clin Sports Med. 1999 Jan;18(1):67-75. doi: 10.1016/s0278-5919(05)70130-7. — View Citation

Chu 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. — View Citation

Czitrom 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. — View Citation

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. — View Citation

Gross 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. — View Citation

Jamali 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. — View Citation

Locht RC, Gross AE, Langer F. Late osteochondral allograft resurfacing for tibial plateau fractures. J Bone Joint Surg Am. 1984 Mar;66(3):328-35. — View Citation

Mankin HJ. The response of articular cartilage to mechanical injury. J Bone Joint Surg Am. 1982 Mar;64(3):460-6. No abstract available. — View Citation

Maury 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. — View Citation

Oakeshott 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. — View Citation

Shasha 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. — View Citation

Sherman 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. Erratum In: J Am Acad Orthop Surg. 2014 Mar;22(3):199. — View Citation

Sirlin 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. — View Citation

Torga 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. — View Citation

Widuchowski 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. — View Citation

Zou S, Dodd RY, Stramer SL, Strong DM; Tissue Safety Study Group. Probability of viremia with HBV, HCV, HIV, and HTLV among tissue donors in the United States. N Engl J Med. 2004 Aug 19;351(8):751-9. doi: 10.1056/NEJMoa032510. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	15 months
Primary	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.	15 months
Primary	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.	15 months
Primary	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.	15 months
Primary	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).	15 months
Primary	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.	15 months
Primary	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.	15 months
Secondary	Age	Years	15 months
Secondary	Sex at birth	Man or female	baseline
Secondary	IMC	kg/m^2	baseline
Secondary	Concomitant procedures	Concomitant procedures (osteotomy, ligamentous repair/reconstruction, meniscal allograft transplantation) are recorded at the time of surgery.	At the surgery
Secondary	Osteochondral allograft type	Patellar, femoral or tibial	At the surgery