Clinical trial NCT04785092: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cartilage Damage
Cartilage Disease
Keywords: cartilage
cartilage defect
articular cartilage repair
All Autologous Cartilage Repair
Autologous Chondrocyte Transplantation
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in knee functionality assessed by KOOS
timeFrame: (before treatment, 6, 12 and 24 months postoperative
Secondary outcomes:
measure: Quality of cartilage repair tissue MRI evaluation
timeFrame: 12 and 24 months
measure: Difference between baseline and follow-up visits of the physical examination
timeFrame: Baseline, 6, 12 and 24 months
measure: Marx activity rating scale (MARS)
timeFrame: Baseline, 6, 12 and 24 months
measure: Numeric Rating Scale (NRS) for pain
timeFrame: Baseline, 6, 12 and 24 months
measure: Baseline quality of cartilage repair tissue MRI evaluation
timeFrame: baseline
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References:
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.
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.
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.
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.