Triphasic Osteochondral Scaffold for the Treatment of the OCD of the Knee: Observational Study

Recruiting

• Conditions: Osteochondritis Dissecans Knee

• Registration Number: NCT05332288
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2022-04-11
• Study First Submitted QC: 2022-04-11
• Study First Posted: 2022-04-18
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-18
• Primary Completion: 2024-08
• Study Completion: 2029-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

• -Additional grade III or IV cartilage injury on the knee being treated;
• Advanced osteoarthritis
• Systemic or localized infection
• Systemic (e.g. rheumatoid arthritis) or local (e.g. synovitis) inflammatory diseases and cardiovascular diseases
• Immune system disorders
• Degenerative or vascular bone pathology (e.g. osteonecrosis)
• Coagulation disorders
• Systemic conditions that alter wound healing
• Established allergy to equine collagen and calcium phosphate salts
• Presence of ligamentous/patellofemoral instability/malignment, varus or valgus malalignment ≤ 3° that cannot be treated/corrected simultaneously;
• Previous tendon repair, ligamentous reconstruction, or realignment procedures within the past 12 months;
• Presence of any known human immunodeficiency virus, hepatitis, syphilis, malignant neoplasms and ongoing anti-neoplastic chemotherapy and radiation treatment; Uncontrolled diabetes; Uncontrolled thyroid function changes; Uncontrolled metabolic disorders; Renal disease and hypercalcemia
• Uncooperative patients, including those with a history of alcohol and drug abuse; Participation in another clinical trial or medical device trial that clinically interferes with the present pilot study;
• Incapacitated patients;
• Pregnant or lactating women. In particular, in the case of a suspected pregnancy in a patient of childbearing age, this will be excluded by serological testing (hCG).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IKDC-Subjective Score	24 months	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

Secondary Outcome Measures

Name	Time	Method
IKDC-Subjective Score	baseline, 6 months, 12 months, 60 months	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
IKDC-Objective Score	baseline, 6 months, 12 months, 24 months, 60 months	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;
EQ-5D (EuroQoL) Current Health Assessment	baseline, 6 months, 12 months, 24 months, 60 months	The EQ-5D profile, asks patients to classify their health based on self-assessed levels of problems ("no", "some", "extreme") on five dimensions.
TegnerActivity Level Scale	baseline, 6 months, 12 months, 24 months, 60 months	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
Patient Acceptable Symptom State (PASS	baseline, 6 months, 12 months, 24 months, 60 months	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"
KOOS Score	baseline, 6 months, 12 months, 24 months, 60 months	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).
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score	12 months, 24 months, 60 months	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;

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy