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

Summary

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.

Conditions

• The Focus of the Study is the Quality and Amount of Regenerated Articular Cartilage.

Interventions

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.

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.

Sponsors & Collaborators

• Shetty-Kim Research Foundation

  lead OTHER

Principal Investigators

• Asode A Shetty, MD, MCh, PhD, FRCS · Canterbury Christ Church University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-01-31

Primary Completion

2016-12-31

Completion

2017-06-30

Countries

• United Kingdom

Study Locations