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OpenTrials
Completed

NCT Number: NCT00560664

Comparison of Autologous Chondrocyte Implantation Versus Mosaicoplasty: a Randomized Trial

Numerous surgical techniques have been developped for the treatment of chondral and osteochondral defects of the knee. Among those techniques autologous chondrocyte transplantation (ACT) was promising but have potential drawbacks. A novel development by TBF is available. The aim of this randomized trial is to compared this new ACT technique to mosaicoplasty. Final outcomes were measured at 2 years using clinical evaluation scoring system (International Knee Documentation Committee), MRI and arthroscopy with biopsy. 64 patients are needed to detect a mean IKDC difference of at least 15 points with 90% power at a 5% alpha level. Twelve surgical centers in France are involved.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU de Lyon, Lyon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • isolated femoral osteochondral lesion
  • aged 18 to 50
  • grade 3 or 4 lesion (ICRS) sized 2,5 cm2 to 7,5 cm2.
  • IKDC score below 55

Exclusion criteria

  • pregnancy
  • allergy
  • arthrosis
  • varus or valgus angle greater than 10°
  • ACL laxity
  • Severe chronic disease
  • BMI > 30 Kg/m2
  • HIV, B or C Hepatitis

Treatment and study plan

Autologous chondrocytes transplantation

Procedure

Cartilage was harvested, then transferred for cell isolation and culture. Cells are suspended in agarose and transferred to cylindrical molds and surgically implanted 4 weeks later.

Other names: Tissue Bank France

Mosaicoplasty

Procedure

Osteochondral patch are sampled and then implanted during the same surgical procedure

Primary outcomes

  1. Clinical evaluation scoring system

    Time frame: IKDC

Secondary outcomes

  1. MRI

    Time frame: at 2 years

  2. Arthroscopy with biopsy

    Time frame: at 2 years

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

Phase 3 Study Comparison of Autologous Chondrocyte Implantation Versus Mosaicoplasty

Acronym: Cartipatch

Important dates

Study start
2007
Primary completion
2012
Study completion
2013
First posted
Nov 20, 2007
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.