A Study to Compare Two Techniques for Articular Cartilage Repair: Cultured Chondrocytes Vs. Cultured BMAC

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by Shetty-Kim Research Foundation
Sponsor:
Information provided by (Responsible Party):
Shetty-Kim Research Foundation
ClinicalTrials.gov Identifier:
NCT01961973
First received: October 10, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  Purpose

Study Title: A study to compare two articular cartilage repair techniques in the knee joint: The use of Cultured Chondrocytes Vs. Cultured bone marrow aspiration cells.

Study hypothesis: We start with the hypothesis that both treatments are equally effective.

Trial Design: 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. The post-operative rehabilitation process will be the same for both groups.

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 group

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 by studying pain relief, cartilage growth and improvement in function.

Primary Endpoint: At the end of the 2 year follow up for all participating patients.


Condition Intervention
The Focus of the Study is the Quality and Amount of Regenerated Articular Cartilage.
Procedure: Cultured Chondrocytes
Procedure: Cultured BMAC

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: Trial to Compare the Efficacy of Two Surgical Techniques for Articular Cartilage Repair in the Knee: The Use of Cultured Chondrocytes Vs. the Use of Cultured Bone Marrow Aspirate Cells.

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 the use of cultured chondrocytes and the use of cultured bone marrow aspirate cells (BMAC). 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, KOOS, Lysholm scores 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 the use of cultured chondrocytes and the use of cultured bone marrow aspirate cells (BMAC). The principal objective of is to ascertain and assess the superiority, if any, of either surgical technique over the other. The radiological superiority will be assessed with by MOCART scores 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: Cultured chondrocytes

Cultured chondrocytes:

This method has two stages. In the first stage, a knee arthroscopy is done to harvest viable cartilage cells which are then sent to a lab to be cultured for 6 weeks. In the second stage, an arthrotomy is performed. The area of cartilage deficiency is prepared and the cultured cells are transplanted onto it. After discharge from the hospital, the patient is advised partial weight bearing on the operated leg for 6 weeks after the surgery.

Procedure: Cultured Chondrocytes
This method has two stages. In the first stage, a knee arthroscopy is done to harvest viable cartilage cells which are then sent to a lab to be cultured for 6 weeks. In the second stage, an arthrotomy is performed. The area of cartilage deficiency is prepared and the cultured cells are transplanted onto it. After discharge from the hospital, the patient is advised partial weight bearing on the operated leg for 6 weeks after the surgery.
Active Comparator: Cultured BMAC
This method also has two major stages. The first stage involves harvesting BMAC from the patient's iliac crest (hip bone), which are then sent to the laboratory for culture for 3 weeks. Simultaneously, an arthroscopy is performed on the affected knee and the area of cartilage deficiency is debrided and microfractured. In the second stage, the cultured BMAC are injected into the affected knee and cells attach themselves to the microfractured area. The patient is then recalled at 4, 5 and 6 weeks from the first stage for an injection of Hyaluronic Acid into the operated knee.
Procedure: Cultured BMAC
This method also has two major stages. The first stage involves harvesting BMAC from the patient's iliac crest (hip bone), which are then sent to the laboratory for culture for 3 weeks. Simultaneously, an arthroscopy is performed on the affected knee and the area of cartilage deficiency is debrided and microfractured. In the second stage, the cultured BMAC are injected into the affected knee and cells attach themselves to the microfractured area. The patient is then recalled at 4, 5 and 6 weeks from the first stage for an injection of Hyaluronic Acid into the operated knee.

  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 cm2

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 cm2
  • 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: NCT01961973

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

Locations
United Kingdom
Kent Knee Unit Not yet recruiting
Walderslade, Kent, United Kingdom, ME5 9PG
Contact: Vishvas A Shetty, MBBS, MCh    +44 1634 662813    vishvas.shetty@doctors.org.uk   
Sub-Investigator: Vishvas A Shetty, MBBS, MCh         
Sub-Investigator: Seok-Jung Kim, MD, PhD, FRCS         
Sub-Investigator: Praveen Bilagi, MRCS, FRCR         
Sub-Investigator: Majid Chowdhry, MRCS         
Sponsors and Collaborators
Shetty-Kim Research Foundation
Investigators
Principal Investigator: Asode A Shetty, MD, MCh, PhD, FRCS Canterbury Christ Church University
  More Information

No publications provided

Responsible Party: Shetty-Kim Research Foundation
ClinicalTrials.gov Identifier: NCT01961973     History of Changes
Other Study ID Numbers: ShettyKimRF 001
Study First Received: October 10, 2013
Last Updated: October 10, 2013
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on October 19, 2014