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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by Shetty-Kim Research Foundation
Sponsor:
Information provided by (Responsible Party):
Shetty-Kim Research Foundation
ClinicalTrials.gov Identifier:
NCT01984450
First received: October 11, 2013
Last updated: November 13, 2013
Last verified: November 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Shetty-Kim Research Foundation
ClinicalTrials.gov Identifier: NCT01984450     History of Changes
Other Study ID Numbers: SKRF 002
Study First Received: October 11, 2013
Last Updated: November 13, 2013
Health Authority: United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014