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

NCT01984450 | Unknown DMC

• 1 other identifier: SKRF 002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Articular Cartilage Defect

Keywords

Articular cartilage; Autologous collagen; BMAC

Outcome Measures

Primary Outcomes (4)

• Clinical outcome

  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

  2 years

• Radiological outcome

  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

  2 years

• Clinical outcome

  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

  2 years

• Clinical outcome

  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

  2 years

Study Arms (2)

ACIC

ACTIVE COMPARATOR

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; Device: implant with a collagen + fibrin gel mixture

MCIC

ACTIVE COMPARATOR

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

Interventions

ACIC PROCEDURE

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.

ACIC

MCIC PROCEDURE

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.

MCIC

implant with a collagen + fibrin gel mixture DEVICE

ACIC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shetty-Kim Research Foundation: lead

Study Sites (1)

Kent Knee Unit

Walderslade, Kent, ME5 9PG, United Kingdom

Location

MeSH Terms

Interventions

Acyclovir; Mutagenesis, Insertional

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Protein Engineering; Genetic Engineering; Genetic Techniques; Investigative Techniques; Mutation; Genetic Variation; Genetic Phenomena; Mutagenesis

Study Officials

• Asode A Shetty, MD, PhD, MCh, FRCS

  Canterbury Christ Church University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asode A Shetty, MD, PhD, MCh, FRCS

CONTACT

01634 662813; aashetty@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2013
• First Posted: November 14, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: November 14, 2013

Record last verified: 2013-11

Locations

GB (1)