All Autologous Cartilage Regeneration in the Treatment of the Knee Cartilage Defects
Primary Purpose
Cartilage Damage, Cartilage Disease
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
All Autologous Cartilage Regeneration
Sponsored by
About this trial
This is an interventional treatment trial for Cartilage Damage focused on measuring cartilage, cartilage defect, articular cartilage repair, All Autologous Cartilage Repair, Autologous Chondrocyte Transplantation
Eligibility Criteria
Inclusion Criteria:
- Singular symptomatic chondral lesion classified as ICRS III or IV at the femoral condyle with less than 3 mm bone damage under the subchondral plate;
- Lesion between 1 and 8 cm2;
- BMI ≤ 34;
- Ability and will to actively participate in a strict rehabilitation protocol and follow-up.
Exclusion Criteria:
- Previous cartilage operation on the injured knee
- Additional grade III or IV lesion on the same knee
- Previous arthroscopic treatments that affect the AACR technique
- Ligamentous/patellofemoral instability/malposition, varus or valgus malposition ≤3° which cannot be treated/corrected simultaneously
- Previous tendon repair, ligament reconstruction or realignment within the last 6 months
- Any known human immunodeficiency virus, hepatitis, syphilis, malignancy or uncontrolled diabetes
- Uncooperative patients who disregard or cannot follow instructions, including those who abuse drugs and/or alcohol
- Participation in a clinical drug or medical device trial that clinically interferes with the present observational study
- Inability to follow procedures (i.e. dementia)
- Inability to give consent
- No understanding of German language
- Pregnant or lactating women
Sites / Locations
- Istituto Ortopedico RizzoliRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment - All Autologous Cartilage Regeneration
Arm Description
Outcomes
Primary Outcome Measures
Change in knee functionality assessed by KOOS
The primary clinical outcome is the change in knee functionality assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire over 2 years (before treatment, at baseline, versus 6, 12 and 24 months postoperative). The KOOS is a Patient Reported Outcome Measure (PROM) designed to asses patient-relevant outcomes following knee injury.
It is a self-completion questionnaire with a 1-week-recall-period with 42 items and 5 subscales (pain, symptoms, activities of daily life, sport and leisure, quality of life associated with the knee joint). Each question has five answering options, scored with a numerical value of 0 - 4. In average, it takes 10 minutes to complete. The calculation of the respective sub-score is done by adding up the marked items of the relevant subscales. These numerical values are then converted into a scale value between 0 (extreme knee problems) and 100 (free of knee joint complaints).
Secondary Outcome Measures
Quality of cartilage repair tissue MRI evaluation
The quality of cartilage repair tissue will be assessed with the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART). The MOCART score is the variable of primary interest because it allows both the evaluation of cartilage repair tissue and the surrounding structures. The MOCART score is based on nine variables measured on a standard MRI and added up to a score, ranging from 0 to 100, where 100 represents the best score and a score of 0 represents the worst score.
Difference between baseline and follow-up visits of the physical examination
The physical examination will evaluate the knee swelling, dynamic and static alignment.
Marx activity rating scale (MARS)
is patient-administered and takes only 1 minute to complete. It includes 4 items that assess the frequency of running, cutting, decelerating, and pivoting based on the subjects "healthiest and most active state in the past year." Each question has five answering options, scored with a numerical value of 0 - 4. The score of all items is summed up for the total score, which ranges from 0 (lowest physical or sporting activity) to 16 (highest physical or sporting activity).
Numeric Rating Scale (NRS) for pain
is a single item question about the average pain on ordinary days with average physical activity, where numerical answers are anchored by 0 (no pain) and 10 (worst possible pain)
Baseline quality of cartilage repair tissue MRI evaluation
The AMADEUS (Area Measurement And DEpth & Underlying Structures) scoring system includes the three most important different parameters that describe a focal chondral or osteochondral defect prior to possible cartilage repair surgery: (1) the cartilage defect area, which is measured ("area measurement"); (2) the cartilage defect morphology/depth ("depth"); and (3) the underlying structures with presence of adjacent osseous defects/subchondral cysts and bone marrow edema-like lesions (BME) ("under- lying structures"). In addition to the resulting AMADEUS code, sub-scores were defined for each feature, which sum up to a total score of 100 (no osteochondral defect) to 0 (worst score).
Full Information
NCT ID
NCT04785092
First Posted
February 15, 2021
Last Updated
September 27, 2023
Sponsor
Istituto Ortopedico Rizzoli
1. Study Identification
Unique Protocol Identification Number
NCT04785092
Brief Title
All Autologous Cartilage Regeneration in the Treatment of the Knee Cartilage Defects
Official Title
All Autologous Cartilage Regeneration in the Treatment of the Knee Cartilage Defects: Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The cartilage articular defects of the knee are extremely disabling lesions and represent one of the predisposition causes to the development of articular arthrosis.
When clinical symptoms are present, exist the indication to treat the patient surgically, to this end, several surgical techniques could be performed, as the microfractures, osteochondral transplantation (OCT) or chondrocytes autologous transplantation (ACT).
The aim of this pilot study is to evaluate the clinical performance of a modified version of the ACT technique, the All Autologous Cartilage Repair technique (AACR). A one-step technique in which the healthy cartilage harvested is fragmented directly in situ and then mixed with the autologous platelet concentrate and directly injected in the cartilage defect.. This lead to a less invasive surgery and cost-effective procedure.
The performance will be evaluated through the evaluation of clinical results and complications after surgery other than the evaluation of the quality of the cartilage tissue repaired.
Detailed Description
The aim of the Pilot Study is to describe the clinical performance of the AACR technique in the treatment of the cartilage defects in terms of complications after surgery, quality of the repaired cartilage tissue and clinical results with regard to pain and function of the treated knee.
The quality of the repaired cartilage tissue will be evaluate through MRI and clinical outcomes by the Patient Reported Outcome Measures (PROMs).
All patients will undergo to a blood sample (used to product the patient's own platelet concentrate) and an arthroscopic procedure to debride degenerated cartilage tissue and to the harvesting of the surrounding healthy cartilage. The fragmented healthy cartilage will mixed with the platelet concentrate (PC) and injected directly into the cartilage defect to fill it. The platelet concentrate stimulates the healing of the cartilage most actively.
Before and after surgical treatment all patient will undergo to a follow-up visits after 6, 12 and 24 months. MRI will be performed at pre-surgery visit and at the 12 and 24 follow-up visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cartilage Damage, Cartilage Disease
Keywords
cartilage, cartilage defect, articular cartilage repair, All Autologous Cartilage Repair, Autologous Chondrocyte Transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment - All Autologous Cartilage Regeneration
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
All Autologous Cartilage Regeneration
Other Intervention Name(s)
Autologous cartilage transplantation
Intervention Description
All patients will undergo firstly to a blood sampling and then to the arthroscopic debridement of the damage cartilage and subsequently will be harvested the surrounding healthy cartilage The harvested and healthy cartilage will shredded directly in situ with a shaver. This cartilage will then mixed with the patient's own Platelet Concentrate and may be injected directly into the cartilage defect. The Platelet Concentrate stimulates the healing of the cartilage most effectively. At the same time, the Platelet Concentrate will also used to produce autologous fibrin glue, which can be used to fix the applied cartilage chip / Platelet Concentrate product quickly and safely in the damaged cartilage.
Primary Outcome Measure Information:
Title
Change in knee functionality assessed by KOOS
Description
The primary clinical outcome is the change in knee functionality assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire over 2 years (before treatment, at baseline, versus 6, 12 and 24 months postoperative). The KOOS is a Patient Reported Outcome Measure (PROM) designed to asses patient-relevant outcomes following knee injury.
It is a self-completion questionnaire with a 1-week-recall-period with 42 items and 5 subscales (pain, symptoms, activities of daily life, sport and leisure, quality of life associated with the knee joint). Each question has five answering options, scored with a numerical value of 0 - 4. In average, it takes 10 minutes to complete. The calculation of the respective sub-score is done by adding up the marked items of the relevant subscales. These numerical values are then converted into a scale value between 0 (extreme knee problems) and 100 (free of knee joint complaints).
Time Frame
(before treatment, 6, 12 and 24 months postoperative
Secondary Outcome Measure Information:
Title
Quality of cartilage repair tissue MRI evaluation
Description
The quality of cartilage repair tissue will be assessed with the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART). The MOCART score is the variable of primary interest because it allows both the evaluation of cartilage repair tissue and the surrounding structures. The MOCART score is based on nine variables measured on a standard MRI and added up to a score, ranging from 0 to 100, where 100 represents the best score and a score of 0 represents the worst score.
Time Frame
12 and 24 months
Title
Difference between baseline and follow-up visits of the physical examination
Description
The physical examination will evaluate the knee swelling, dynamic and static alignment.
Time Frame
Baseline, 6, 12 and 24 months
Title
Marx activity rating scale (MARS)
Description
is patient-administered and takes only 1 minute to complete. It includes 4 items that assess the frequency of running, cutting, decelerating, and pivoting based on the subjects "healthiest and most active state in the past year." Each question has five answering options, scored with a numerical value of 0 - 4. The score of all items is summed up for the total score, which ranges from 0 (lowest physical or sporting activity) to 16 (highest physical or sporting activity).
Time Frame
Baseline, 6, 12 and 24 months
Title
Numeric Rating Scale (NRS) for pain
Description
is a single item question about the average pain on ordinary days with average physical activity, where numerical answers are anchored by 0 (no pain) and 10 (worst possible pain)
Time Frame
Baseline, 6, 12 and 24 months
Title
Baseline quality of cartilage repair tissue MRI evaluation
Description
The AMADEUS (Area Measurement And DEpth & Underlying Structures) scoring system includes the three most important different parameters that describe a focal chondral or osteochondral defect prior to possible cartilage repair surgery: (1) the cartilage defect area, which is measured ("area measurement"); (2) the cartilage defect morphology/depth ("depth"); and (3) the underlying structures with presence of adjacent osseous defects/subchondral cysts and bone marrow edema-like lesions (BME) ("under- lying structures"). In addition to the resulting AMADEUS code, sub-scores were defined for each feature, which sum up to a total score of 100 (no osteochondral defect) to 0 (worst score).
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Singular symptomatic chondral lesion classified as ICRS III or IV at the femoral condyle with less than 3 mm bone damage under the subchondral plate;
Lesion between 1 and 8 cm2;
BMI ≤ 34;
Ability and will to actively participate in a strict rehabilitation protocol and follow-up.
Exclusion Criteria:
Previous cartilage operation on the injured knee
Additional grade III or IV lesion on the same knee
Previous arthroscopic treatments that affect the AACR technique
Ligamentous/patellofemoral instability/malposition, varus or valgus malposition ≤3° which cannot be treated/corrected simultaneously
Previous tendon repair, ligament reconstruction or realignment within the last 6 months
Any known human immunodeficiency virus, hepatitis, syphilis, malignancy or uncontrolled diabetes
Uncooperative patients who disregard or cannot follow instructions, including those who abuse drugs and/or alcohol
Participation in a clinical drug or medical device trial that clinically interferes with the present observational study
Inability to follow procedures (i.e. dementia)
Inability to give consent
No understanding of German language
Pregnant or lactating women
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Zaffagnini, Prof. MD.
Phone
6366567
Ext
051
Email
stefano.zaffagnini@ior.it
First Name & Middle Initial & Last Name & Degree
Daniele Andreani, M.Sc
Phone
0516336072
Email
daniele.andreani@ior.it
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31220632
Citation
Na Y, Shi Y, Liu W, Jia Y, Kong L, Zhang T, Han C, Ren Y. Is implantation of autologous chondrocytes superior to microfracture for articular-cartilage defects of the knee? A systematic review of 5-year follow-up data. Int J Surg. 2019 Aug;68:56-62. doi: 10.1016/j.ijsu.2019.06.007. Epub 2019 Jun 18.
Results Reference
background
PubMed Identifier
8078550
Citation
Brittberg M, Lindahl A, Nilsson A, Ohlsson C, Isaksson O, Peterson L. Treatment of deep cartilage defects in the knee with autologous chondrocyte transplantation. N Engl J Med. 1994 Oct 6;331(14):889-95. doi: 10.1056/NEJM199410063311401.
Results Reference
background
PubMed Identifier
31223628
Citation
Massen FK, Inauen CR, Harder LP, Runer A, Preiss S, Salzmann GM. One-Step Autologous Minced Cartilage Procedure for the Treatment of Knee Joint Chondral and Osteochondral Lesions: A Series of 27 Patients With 2-Year Follow-up. Orthop J Sports Med. 2019 Jun 13;7(6):2325967119853773. doi: 10.1177/2325967119853773. eCollection 2019 Jun.
Results Reference
background
PubMed Identifier
12925617
Citation
Brittberg M, Peterson L, Sjogren-Jansson E, Tallheden T, Lindahl A. Articular cartilage engineering with autologous chondrocyte transplantation. A review of recent developments. J Bone Joint Surg Am. 2003;85-A Suppl 3:109-15. doi: 10.2106/00004623-200300003-00017. No abstract available.
Results Reference
background
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All Autologous Cartilage Regeneration in the Treatment of the Knee Cartilage Defects
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