All Autologous Cartilage Regeneration in the Treatment of the Knee Cartilage Defects

NCT04785092 | Completed

• 1 other identifier: AACR
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cartilage Damage; Cartilage Disease

Keywords

cartilage; cartilage defect; articular cartilage repair; All Autologous Cartilage Repair; Autologous Chondrocyte Transplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Quality of cartilage repair tissue MRI evaluation

  12 and 24 months

• Difference between baseline and follow-up visits of the physical examination

  Baseline, 6, 12 and 24 months

• Marx activity rating scale (MARS)

  Baseline, 6, 12 and 24 months

• Numeric Rating Scale (NRS) for pain

  Baseline, 6, 12 and 24 months

• Baseline quality of cartilage repair tissue MRI evaluation

  baseline

Study Arms (1)

Treatment - All Autologous Cartilage Regeneration

EXPERIMENTAL

Procedure: All Autologous Cartilage Regeneration

Interventions

All Autologous Cartilage Regeneration PROCEDURE

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.

Also known as: Autologous cartilage transplantation

Treatment - All Autologous Cartilage Regeneration

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40124, Italy

Location

Related Publications (4)

• 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.

  PMID: 31220632 BACKGROUND

• 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.

  PMID: 8078550 BACKGROUND

• 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.

  PMID: 31223628 BACKGROUND

• 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.

  PMID: 12925617 BACKGROUND

MeSH Terms

Conditions

Cartilage Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: March 5, 2021
• Study Start: March 1, 2021
• Primary Completion: January 21, 2025
• Study Completion: January 21, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)