Articular Cartilage Defect Clinical Trial
Official title:
A Study to Compare Two Articular Cartilage Repair Techniques in the Knee Joint: Autologous Collagen Induced Chondrogenesis (ACIC) Vs. Mesenchymal Cell Induced Chondrogenesis (MCIC).
Study Title: A study to compare two articular cartilage repair techniques in the knee joint:
Autologous Collagen Induced Chondrogenesis (ACIC) Vs. Mesenchymal Cell Induced
Chondrogenesis (MCIC).
Study hypothesis: We start with the hypothesis that both treatments are equally effective.
Trial Design: This is a prospective study. The participating patients will be divided into
two groups, each group receiving either one of the treatment modalities. This study will not
be randomised or blinded. Both procedures will be done at the Spire Alexandra Hospital by
Professor A. A Shetty, who is one half of the team that devised both techniques.
Trial Participants: All participants will be from patients attending Professor Shetty's
clinic at the Spire Alexandra Hospital.
Planned Sample Size: 50 patients in each arm.
Follow-up duration: The participating patients will be followed up at 2 weeks, 6 weeks, 3
months, 6 months, 1 year and 2 years following the surgery by visits to the clinic and
assessed clinically. The surgical outcomes will be measured by by IKDC, KOOS and Lysholm
scores; cartilage growth will be measured by the MOCART score.
Planned Trial Period: Two to three years
Primary Objective: To establish superiority, if any, of either procedure over the other.
Primary Endpoint: At the end of the 2 year follow up for all participating patients.
BACKGROUND: Articular cartilage repair in the knee is aimed at young patients with area(s)
of cartilage loss and no deformity of the knee. These patients aren't indicated for a knee
replacement. Articular cartilage repair leads to improvement of symptoms of pain, locking
and function. Traditionally, articular cartilage repair has always involved exposing the
entire knee joint with an arthrotomy. This, though effective, would lead to a large scar,
longer hospital stay, longer rehabilitation and its associated complications. Also, the use
of Bone Marrow Aspirate Cells (BMAC) for the purpose of cartilage repair has long been
debated with both sides having valid arguments and good surgical results.
RATIONALE: Both procedures in this study are performed in one stage, arthroscopically and as
day case procedures, which offers minimal scarring and quicker recovery. This automatically
confers a significant advantage over the traditional surgical techniques.
To correct the articular cartilage defect, the ACIC method requires autologous
Atellocollagen (a protein based structure), while the MCIC method uses concentrated BMAC
taken from the patient's iliac crest.
Both procedures have shown encouraging results in terms of pain relief, cartilage growth and
improved function. Since one technique utilises a protein based reagent and the other
involves mesenchymal cells, this study aims to ascertain if either technique is superior to
the other.
STUDY DESIGN: This study aims to compare two techniques of articular cartilage repair in the
knee, namely Autologous Collagen Induced Chondrogenesis (ACIC) and Mesenchymal Cell Induced
Chondrogenesis (MCIC). The principal objective of is to ascertain and assess the
superiority, if any, of either surgical technique over the other. The superiority will be
assessed with by the certain scoring systems (IKDC, KOOS, Lysholm and MOCART) measured pre-
and post-operatively.
Depending on which procedure the patient chooses to have, they will be allotted to either
the ACIC or the MCIC group. The patient is followed up in the clinic at the Spire Alexandra
Hospital at 2 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years following the surgery
and their progress is documented by questionnaires and clinical examination. MRI scans are
done at one and two years to assess the extent of cartilage growth.
SURGICAL TECHNIQUES
Autologous Collagen Induced Chondrogenesis (ACIC):
ACIC is a single stage arthroscopic procedure. It is done as a day case? procedure and the
patient is admitted a few hours before the procedure. The anaesthetic method depends is the
Anaesthesiologist's prerogative and depends on the patient's general health. Under sterile
conditions in an operating theatre, the arthroscopic instruments are introduced inside the
knee joint. As assessed previously by MRI scans, the area of cartilage defect is debrided by
curettage, shaving and burring and then microfractured. The ACIC method utilises autologous
Atellocollagen, a protein based structure, mixed with thrombin and fibrinogen to form a gel
which coats the area with a cartilage defect. The entry ports are then closed and the knee
is covered with a sterile dressing. The patient is transferred to the surgical recovery ward
and, when medically stable, then transferred to their room on the ward.
After discharge from the hospital, the patient is advised partial weight bearing on the
operated leg for 6 weeks after the surgery. They also undergo 5 sessions of physiotherapy.
Surgical clips and sutures are removed at 2 weeks following the surgery.
Mesenchymal Cell Induced Chondrogenesis (MCIC):
MCIC is a single stage arthroscopic procedure. It is done as a day case? procedure and the
patient is admitted a few hours before the procedure. The anaesthetic method depends is the
Anaesthesiologist's prerogative and depends on the patient's general health. Under sterile
conditions in an operating theatre, the arthroscopic instruments are introduced inside the
knee joint. As assessed previously by MRI scans, the area of cartilage defect is debrided by
curettage, shaving and burring and then microfractured. The MCIC method involves aspiration
of Bone Marrow Aspirate Cells (BMAC) from the patient's iliac crest (hip bone) and
concentrating the cells by centrifugation in the operation theatre itself. The BMAC are then
mixed with thrombin and fibrinogen to form a gel which coats the area with a cartilage
defect.
After discharge from the hospital, the patient is advised partial weight bearing on the
operated leg for 6 weeks after the surgery. They also undergo 5 sessions of physiotherapy.
Surgical clips and sutures are removed at 2 weeks following the surgery.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04840147 -
A Comparison of JointRep® and Microfracture in Repair of Cartilage Lesions on the Femoral Condyle or Trochlea,
|
N/A | |
| Recruiting |
NCT05942430 -
Autologous Costal Osteochondral Transplantation for Talar Osteochondral Lesions
|
N/A | |
| Recruiting |
NCT04296487 -
Introduction of ACI for Cartilage Repair
|
N/A | |
| Recruiting |
NCT04744402 -
Phase 2 Clinical Trial of CartiLife® in the United States
|
Phase 2 | |
| Recruiting |
NCT03588975 -
A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee
|
Phase 3 | |
| Recruiting |
NCT03219307 -
NOVOCART 3D Treatment Following Microfracture Failure
|
Phase 3 | |
| Active, not recruiting |
NCT05051332 -
Phase 3 Clinical Trial of CartiLife® in Korea
|
Phase 3 | |
| Recruiting |
NCT05402072 -
AMIC Compared With Microfracture for Focal Articular Cartilage Damage of the Hip
|
Phase 1 | |
| Not yet recruiting |
NCT05651997 -
Study Comparing Two Methods for the Treatment of Large Chondral and Osteochondral Defects of the Knee
|
N/A | |
| Completed |
NCT00719576 -
Superiority of MACI® Versus Microfracture Treatment in Patients With Symptomatic Articular Cartilage Defects in the Knee
|
Phase 3 |