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A Study to Compare Two Techniques for Articular Cartilage Repair:ACIC Vs. MCIC

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2013 by Shetty-Kim Research Foundation.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01984450
First Posted: November 14, 2013
Last Update Posted: November 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shetty-Kim Research Foundation
  Purpose

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.


Condition Intervention
Articular Cartilage Defect Procedure: ACIC Procedure: MCIC Device: implant with a collagen + fibrin gel mixture

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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).

Resource links provided by NLM:


Further study details as provided by Shetty-Kim Research Foundation:

Primary Outcome Measures:
  • Clinical outcome [ Time Frame: 2 years ]
    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 IKDC score measured pre- and post-operatively

  • Radiological outcome [ Time Frame: 2 years ]
    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 MOCART score measured pre- and post-operatively

  • Clinical outcome [ Time Frame: 2 years ]
    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 KOOS score measured pre- and post-operatively

  • Clinical outcome [ Time Frame: 2 years ]
    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 Lysholm score measured pre- and post-operatively


Estimated Enrollment: 100
Study Start Date: January 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ACIC
The patients in this group will be treated by the ACIC technique, which uses autologous collagen to regenerate articular cartilage. ACIC is a single stage arthroscopic procedure. It is done as a day case procedure. The cartilage defect is debrided and implanted with a collagen + fibrin gel mixture under CO2 insufflation.
Procedure: ACIC

Autologous Collagen Induced Chondrogenesis (ACIC):

ACIC is a single stage arthroscopic procedure. It is done as a day case procedure. The cartilage defect is debrided and implanted with a collagen + fibrin gel mixture under CO2 insufflation.

Device: implant with a collagen + fibrin gel mixture
Active Comparator: MCIC
The patients in this group will be treated by the MCIC technique, which uses concentrated BMAC to regenerate articular cartilage. MCIC is a single stage arthroscopic procedure. It is done as a day case procedure. BMAC is harvested intraoperatively and concentrated. It is then mixed with a fibrin gel and implanted under CO2 insufflation.
Procedure: MCIC

Mesenchymal Cell Induced Chondrogenesis (MCIC):

MCIC is a single stage arthroscopic procedure. It is done as a day case procedure. BMAC is harvested intraoperatively and concentrated. It is then mixed with a fibrin gel and implanted under CO2 insufflation.


  Hide Detailed Description

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 years to 65 years.
  • Diagnosed with articular cartilage defect in the knee (ICRS/Outerbridge grade III/IV cartilage lesions as assessed on MRI scan).
  • No other significant medical co-morbidities, as assessed by pre-operatively, that could interfere with surgery results of trial eg. Hypertension, COPD etc.
  • Participant has clinically acceptable laboratory and ECG tests at pre-assessment clinic.
  • Able (in the Investigators opinion) and willing to comply with all study requirements.
  • Up to 3 lesions of sizes 2-8 square cm.

Exclusion Criteria:

  • Generalized and/or inflammatory arthritis
  • Active joint inflammation
  • More than 5 degrees of varus or valgus deformity
  • Age below 18 and over 65 years
  • More than 4 lesions
  • Lesions more than 8 square cm.
  • Significant co-morbidities or classified as ASA grade 3/4
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01984450


Contacts
Contact: Asode A Shetty, MD, PhD, MCh, FRCS 01634 662813 aashetty@hotmail.com

Locations
United Kingdom
Kent Knee Unit
Walderslade, Kent, United Kingdom, ME5 9PG
Sponsors and Collaborators
Shetty-Kim Research Foundation
Investigators
Principal Investigator: Asode A Shetty, MD, PhD, MCh, FRCS Canterbury Christ Church University
  More Information

Responsible Party: Shetty-Kim Research Foundation
ClinicalTrials.gov Identifier: NCT01984450     History of Changes
Other Study ID Numbers: SKRF 002
First Submitted: October 11, 2013
First Posted: November 14, 2013
Last Update Posted: November 14, 2013
Last Verified: November 2013

Keywords provided by Shetty-Kim Research Foundation:
Articular cartilage
Autologous collagen
BMAC

Additional relevant MeSH terms:
Cartilage Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Acyclovir
Antiviral Agents
Anti-Infective Agents