Cartilage Damage Clinical Trial
Official title:
All Autologous Cartilage Regeneration in the Treatment of the Knee Cartilage Defects: Pilot Study
NCT number | NCT04785092 |
Other study ID # | AACR |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2021 |
Est. completion date | July 1, 2024 |
Verified date | June 2024 |
Source | Istituto Ortopedico Rizzoli |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | July 1, 2024 |
Est. primary completion date | March 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Istituto Ortopedico Rizzoli | Bologna |
Lead Sponsor | Collaborator |
---|---|
Istituto Ortopedico Rizzoli |
Italy,
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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). |
(before treatment, 6, 12 and 24 months postoperative | |
Secondary | 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. | 12 and 24 months | |
Secondary | Difference between baseline and follow-up visits of the physical examination | The physical examination will evaluate the knee swelling, dynamic and static alignment. | Baseline, 6, 12 and 24 months | |
Secondary | 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). | Baseline, 6, 12 and 24 months | |
Secondary | 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, 6, 12 and 24 months | |
Secondary | 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). | baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03755388 -
Clinical Trial of an MRI Based Patient Specific Focal Knee Resurfacing Implant
|
N/A | |
Recruiting |
NCT04716140 -
Prospective Study: The Effect on Clinical Outcome After Treatment of MTP Cartilage Lesions in Hallux Valgus Surgery
|
N/A | |
Recruiting |
NCT06185036 -
Histological Validation of dGEMRIC Indices as a Quantitative Biomarker for Cartilage Damage in the Hip Joint
|
||
Completed |
NCT04889443 -
Spontaneous Healing of ARticular Cartilage (SHARC)
|
||
Completed |
NCT04118023 -
7T MRI to Evaluate Cartilage Defects in the Knee
|
||
Completed |
NCT01473199 -
BioPoly RS Knee Registry Study for Cartilage Defect Replacement
|
N/A | |
Terminated |
NCT05082831 -
Human ECM Implanted Within Microfracture Interstices & the Cartilage Defect in the Knee to Regenerate Hyaline Cartilage
|
Phase 1 | |
Recruiting |
NCT05124613 -
The Impact of Covid-19 on Patients Waiting for Knee Surgery
|
||
Recruiting |
NCT05660161 -
This is a Study to Evaluate Nanofractures Technique in the Treatment of Cartilage Lesions
|
N/A | |
Active, not recruiting |
NCT03873545 -
Prospective Evaluation of ProChondrix CR for Repair of Articular Cartilage Defects on Femoral Condyle and Patella
|
||
Recruiting |
NCT05328674 -
Clinical and Comparative Evaluation of the Treatment Results of Arthroscopic Reconstruction of Cartilage Defects in the Knee Joint With the Use of Autogenous Cartilage Graft With PRP GF (Platelet-rich Plasma With Growth Factors)
|
N/A | |
Not yet recruiting |
NCT02776943 -
UCMSC Transplantation in the Treatment of Cartilage Damage
|
Phase 1/Phase 2 | |
Recruiting |
NCT04236739 -
Comparing Clinical Outcomes of the One-step Cartilage Transplantation in Cartilage Defects of the Knee With Conservative Treatment
|
Phase 3 | |
Completed |
NCT02189408 -
Clinical Study of Pain Reduction by Peri-arthroscopic PRP Application in Knee Degeneration
|
Phase 4 | |
Recruiting |
NCT04626999 -
Single and Double Bundle ACL Reconstructions, in Term of Cartilage Damage Due to Remaining Instability After Surgery.
|
N/A | |
Terminated |
NCT04301258 -
ProChondrix® CR Articular Cartilage Restoration Evaluation (PACE) Registry
|
||
Withdrawn |
NCT04875767 -
Cartilage Repair Using a Hyaluronic Acid-Based Scaffold With Bone Marrow Aspirate Compared With Microfracture for Focal Articular Cartilage Damage of the Hip
|
N/A | |
Recruiting |
NCT05186935 -
Advanced Cartilage Treatment With Injectable-hydrogel Validation of the Effect
|
N/A | |
Not yet recruiting |
NCT02640144 -
The Influence of Hyaluronic Acid Injection Following Knee Arthroscopy
|
Phase 4 | |
Terminated |
NCT04212650 -
Losartan to Improve Hip Microfracture
|
Phase 1/Phase 2 |