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The objective of the present study is to evaluate the clinical results of reconstructive treatment of knee OCD defects treated with osteochondral scaffolds implanted with specific instrumentation.The evaluation will be performed through clinical, subjective and objective assessments.
30 patients affected by OCD of the knee will be included in observational, perspective, monocentric trial. Patients will undergo clinical follow-up visits and administration of questionnaires before surgery and at 6, 12, 24 and 60 months after surgery. A CRF (Case Report Form) related to the patient's specific evaluation will be completed for each visit. Patients will also have imaging (MRI) examinations before surgery and at 12, 24 and 60 months after surgery as per normal clinical practice. Evaluation of the quality of cartilage repair will be assessed by specific MRI radiographic scores.
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| Measure | Description | Time Frame |
|---|---|---|
| IKDC-Subjective Score | This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathologies. All questions examines 3 categories: symptoms, sports activity, and knee function | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| IKDC-Subjective Score | This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathologies. All questions examines 3 categories: symptoms, sports activity, and knee function | baseline, 6 months, 12 months, 60 months |
| IKDC-Objective Score |
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Inclusion Criteria
Exclusion Criteria:
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Patients with knee OCD (ICRS OCD 3-4) with surgical indication for treatment of these lesions by biological reconstructive technique with osteochondral scaffolds will be enrolled. The estimated number of patients enrolled is 30, of which we expect from epidemiological data that about one third (10 patients) are between 15 and 18 years old.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luca Andriolo, MD | Contact | 0516366567 | luca.andriolo@ior.it | |
| Roberta Licciardi, MSc | Contact | 6366567 | 051 | roberta.licciardi@ior.it |
| Name | Affiliation | Role |
|---|---|---|
| Luca Andriolo, MD | Istituto Ortopedico Rizzoli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Rizzoli | Recruiting | Bologna | 40136 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29998741 | Background | Andriolo L, Crawford DC, Reale D, Zaffagnini S, Candrian C, Cavicchioli A, Filardo G. Osteochondritis Dissecans of the Knee: Etiology and Pathogenetic Mechanisms. A Systematic Review. Cartilage. 2020 Jul;11(3):273-290. doi: 10.1177/1947603518786557. Epub 2018 Jul 12. | |
| 29468901 | Background | Andriolo L, Candrian C, Papio T, Cavicchioli A, Perdisa F, Filardo G. Osteochondritis Dissecans of the Knee - Conservative Treatment Strategies: A Systematic Review. Cartilage. 2019 Jul;10(3):267-277. doi: 10.1177/1947603518758435. Epub 2018 Feb 22. |
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| ID | Term |
|---|---|
| D010008 | Osteochondritis Dissecans |
| ID | Term |
|---|---|
| D010007 | Osteochondritis |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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The objective rating scale has seven parameters related to knee function. The presence of effusions and degree of knee motion are assessed; the worst value of any of these parameters determines the final IKDC grade. There are four grades (A, B, C, D) that identify a knee rated as normal, near normal, abnormal, and severely abnormal, respectively; |
| baseline, 6 months, 12 months, 24 months, 60 months |
| KOOS Score | KOOS SCORE consists of 5 subscales and covers: pain (9 items), symptoms (7 items, two of which are related to stiffness), functions and activities of daily living (17 items), physical function, sports and leisure activities (5 items) and quality of life in relation to the knee (4 items). | baseline, 6 months, 12 months, 24 months, 60 months |
| TegnerActivity Level Scale | Tegner activity level scale allows to know the level of physical activity carried out by the patients. Tegner's activity scale classifies the activity according to work and sports activities on a scale from 0 to 10. Zero represents disability because of knee problems and 10 represents soccer a national or international level | baseline, 6 months, 12 months, 24 months, 60 months |
| EQ-5D (EuroQoL) Current Health Assessment | The EQ-5D profile, asks patients to classify their health based on self-assessed levels of problems ("no", "some", "extreme") on five dimensions. | baseline, 6 months, 12 months, 24 months, 60 months |
| Patient Acceptable Symptom State (PASS | A tool to assess patient satisfaction in consideration of their current degree of pain, function, and daily activity. Patients can express if their state of health will be satisfying, answering "yes" or "no" | baseline, 6 months, 12 months, 24 months, 60 months |
| Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score | The MOCART score 2.0 is a data point of interest because it allows for the assessment of both the repair of the specific cartilage tissue and the structures surrounding it. The MOCART score 2.0 is based on nine variables measured on a standard MRI and summed to a score, ranging from 0 to 100, where 100 represents the best score and a score of 0 represents the worst score. The underlying factors that may influence the MOCART 2.0 score are the severity of the defect prior to cartilage repair surgery; | 12 months, 24 months, 60 months |
| 30523367 | Background | Filardo G, Andriolo L, Soler F, Berruto M, Ferrua P, Verdonk P, Rongieras F, Crawford DC. Treatment of unstable knee osteochondritis dissecans in the young adult: results and limitations of surgical strategies-The advantages of allografts to address an osteochondral challenge. Knee Surg Sports Traumatol Arthrosc. 2019 Jun;27(6):1726-1738. doi: 10.1007/s00167-018-5316-5. Epub 2018 Dec 6. |
| 32809120 | Background | Andriolo L, Di Martino A, Altamura SA, Boffa A, Poggi A, Busacca M, Zaffagnini S, Filardo G. Matrix-assisted chondrocyte transplantation with bone grafting for knee osteochondritis dissecans: stable results at 12 years. Knee Surg Sports Traumatol Arthrosc. 2021 Jun;29(6):1830-1840. doi: 10.1007/s00167-020-06230-y. Epub 2020 Aug 18. |
| 29125919 | Background | Minas T, Ogura T, Headrick J, Bryant T. Autologous Chondrocyte Implantation "Sandwich" Technique Compared With Autologous Bone Grafting for Deep Osteochondral Lesions in the Knee. Am J Sports Med. 2018 Feb;46(2):322-332. doi: 10.1177/0363546517738000. Epub 2017 Nov 10. |
| 34331140 | Background | Boffa A, Solaro L, Poggi A, Andriolo L, Reale D, Di Martino A. Multi-layer cell-free scaffolds for osteochondral defects of the knee: a systematic review and meta-analysis of clinical evidence. J Exp Orthop. 2021 Jul 30;8(1):56. doi: 10.1186/s40634-021-00377-4. |
| 28913600 | Background | Kon E, Filardo G, Brittberg M, Busacca M, Condello V, Engebretsen L, Marlovits S, Niemeyer P, Platzer P, Posthumus M, Verdonk P, Verdonk R, Victor J, van der Merwe W, Widuchowski W, Zorzi C, Marcacci M. A multilayer biomaterial for osteochondral regeneration shows superiority vs microfractures for the treatment of osteochondral lesions in a multicentre randomized trial at 2 years. Knee Surg Sports Traumatol Arthrosc. 2018 Sep;26(9):2704-2715. doi: 10.1007/s00167-017-4707-3. Epub 2017 Sep 14. |
| 34283948 | Background | Di Martino A, Perdisa F, Filardo G, Busacca M, Kon E, Marcacci M, Zaffagnini S. Cell-Free Biomimetic Osteochondral Scaffold for the Treatment of Knee Lesions: Clinical and Imaging Results at 10-Year Follow-up. Am J Sports Med. 2021 Aug;49(10):2645-2650. doi: 10.1177/03635465211029292. Epub 2021 Jul 20. |
| 32021725 | Background | Sessa A, Perdisa F, Di Martino A, Zaffagnini S, Filardo G. Cell-Free Biomimetic Osteochondral Scaffold: Implantation Technique. JBJS Essent Surg Tech. 2019 Aug 14;9(3):e27. doi: 10.2106/JBJS.ST.18.00089. eCollection 2019 Jul-Sep. |