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

NCT04236492 | Recruiting

• 1 other identifier: IIBSP-ALO-2018-21
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteochondral Defect

Keywords

fresh osteochondral allografts; integration; osteochondral defect; knee; chondral lesion

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• Age

  15 months

• Sex at birth

  baseline

• IMC

  baseline

• Concomitant procedures

  At the surgery

• Osteochondral allograft type

  At the surgery

Study Arms (1)

Fresh osteochondral allografting

Transplantation of a fresh osteochondral allograft in the knee

Procedure: Fresh osteochondral allografting

Interventions

Fresh osteochondral allografting PROCEDURE

Transplantation of a fresh osteochondral allograft in the knee

Fresh osteochondral allografting

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Specialized care

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Banc de Sang i Teixits: collaborator

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08026, Spain

RECRUITING

Related Publications (16)

• 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.

  PMID: 20216470 BACKGROUND

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

  PMID: 6174527 BACKGROUND

• 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.

  PMID: 24486758 BACKGROUND

• 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.

  PMID: 17428666 BACKGROUND

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

  PMID: 10028117 BACKGROUND

• 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.

  PMID: 3042234 BACKGROUND

• 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.

  PMID: 2324145 BACKGROUND

• 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.

  PMID: 17200323 BACKGROUND

• 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.

  PMID: 11274532 BACKGROUND

• 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.

  PMID: 18465182 BACKGROUND

• 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.

  PMID: 16523140 BACKGROUND

• 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.

  PMID: 10101321 BACKGROUND

• 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.

  PMID: 16056047 BACKGROUND

• 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.

  PMID: 6699046 BACKGROUND

• 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.

  PMID: 12721343 BACKGROUND

• 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.

  PMID: 15317888 BACKGROUND

Study Officials

• Pablo Gelber

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Àlex Grau Blanes

CONTACT

+34935537031; agraub@santpau.cat

Aránzazu González-Osuna

CONTACT

+34935537031; agonzalezo@santpau.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: January 22, 2020
• Study Start: June 6, 2018
• Primary Completion: March 10, 2026
• Study Completion (Estimated): November 10, 2026
• Last Updated: March 16, 2023

Record last verified: 2023-03

Locations

ES (1)